RHEOTHERAPY/RHEOPHERESIS

Rheopheresis® - OccuLogixSM Corporation, through its subsidiary Apheresis Technology, Inc. (ATI), is currently enrolling patients in a final phase multi-center clinical trial on Rheopheresis using Membrane Differential Filtration for the Treatment of Dry Age-related Macular Degeneration. For details.

RheoTherapy

Posted by Richard C. Davis MD on April 08, 1998 at 14:05:30:

Dear Sirs,
We would like to take this opportunity to introduce you to an exciting treatment modality for AMD. RheoTherapy is a therapeutic apheresis methodology we have developed which appears to be effective in improving sight in most of the patients we have treated. In the US, we began treatment in September 1997 and have treated approximately 100 patients to date, with over 90% reporting improvement in their vision. Objectively we have documented significant changes in many standard measures including improvements in angiograms, fundus photos, perimetry, EDTRS & Snellen visual acuity, and others.

Despite the apparent success of the treatment, we have encountered an unfortunate amount of criticism from a subset of less than disinterested retina specialists. Fortunately, they have been unsuccessful in their attempts to malign the company and this unique physiological approach to the treatment of this devastating disease.

A significant portion of our mission is to educate both professionals and the public alike concerning this treatment option. A brochure and patient video are available, as well as telephone consultations.

This is an important breakthrough and needs to be explored fully. In addition to the research conducted over the past 8 years, we are supporting FDA regulated clinical trials in the US as well as additional studies in Europe.

If you have any questions please do not hesitate to contact me at your earliest convenience.

Sincerely,
Richard Davis, MD
President

New treatment for AMD, the RheoTherapy Breakthrough

Posted by Richard C. Davis Jr., M.D. on June 23, 1998 at 20:49:58:

This report is a follow-up to my last messsage posted above on 4/8/98.

1. RheoTherapy blood filtration is one of the most exciting breakthroughs in medicine today. It has emerged quickly and in a non-traditional fashion, so don't let your ophthalmologists' lack of awareness concerning RheoTherapy disturb you. Be patient with them. Those who hold their patients' best interests at heart will be recommending this procedure to all of their patients soon. Many are doing so now. As a result, our clinic in Florida, the RheoTherapyCenters of Tampa Bay, is very busy. Every day patients with both "Wet" and "Dry" forms of the disease see improvement in their vision, many patients with dramatic changes.

2. The best news is the incredible safety, in our hands, of the procedure. To date, NO patient has suffered any morbidity from the procedure and best of all, no one who has received full treatment has worsened. Compare this to laser surgery, which is still recommended by most retina specialists and usually causes permanent damage to the retina.

3. Our negotiations with several dozen of the nation's leading ophthalmologists continue to progress. Hopefully RheoTherapy will be readily available nationwide soon!

4. The clinical trial for our second generation filter technology at the University of Utah is nearing completion and the informal preliminary results appear very promising. Many patients treated with the RheoFilter have had a significant improvement in their vision, enabling them to read newspapers and perform other activities of daily living. Most of the patients are also reporting improvement in their color vision, night vision, and many other areas of complex visual functioning. The final results should be released in September. Those ophthalmologists who initially opposed this technology will be forced to "eat their words" when these results are released. It is always sad to see professionals jump to conclusions without knowing the facts.

Inquiries concerning RheoTherapy should be directed to our website at occulogix.com or call us toll-free at: 1-888-464-7436. Our new brochure and video tape are free of charge and will be able to answer many of your questions in more detail. So please do not hesitate to request this information when you contact us.

I will write again next month.

Sincerely,
Richard C. Davis, M.D.
President and CEO
OccuLogix Corporation

Rheotherapy - Questions & Concerns

Posted by T.S. Taylor on July 01, 1998 at 00:17:06:

The posts by Dr. Richard C. Davis, Jr., about Rheotherapy raise some concerns that should be addressed. There is cause to question whether Rheotherapy is an effective treatment for AMD, as no controlled studies have yet been done.

The State of Florida has taken administrative action against Dr. Davis. I had asked him questions about the status of that investigation, and whether he had nominated an expert to appraise the effectiveness of his therapeutic techniques. He did not reply.

As a result of what it considers to be false advertising, the State of Florida has imposed restrictions on Dr. Davis's practice of medicine, and has commenced an administrative action to suspend or revoke his medical license. The State of Florida will provide free information upon inquiry, which can be made by email to.

I would appreciate it if Dr. Davis would provide a response to the questions I raised. While I want to believe that his treatment works, his lack of response to my prior inquiry makes me wonder if he offers nothing but a $25,000 placebo.

Posted by Richard C. Davis Jr., MD on July 01, 1998 at 12:31:43: In Reply to: Rheotherapy - Questions & Concerns posted by T.S. Taylor on July 01, 1998 at 00:17:06:

Dear T.S. Taylor,
You are not correct in any of the statements you have made here. I hope you will find the actual facts interesting. First, I have replied to all questions concerning the State of Florida. I apologize if you did not receive an answer to your questions. Please contact me again so that I can resend you the information.

Next, as you recall, the State's actions were prompted by a series of retina specialists' complaints, not our patients. This was clearly a political attack. They are definitely feeling the pressure of a technology that really works and are very concerned about their laser business. This entire campaign of misinformation, defamation and slander is all about power, ego and money. If anyone wants proof, we have it.

I find it very interesting in your statements above that you fail to finish the story. Do you remember that upon hearing the facts, the State's order was rescinded immediately. Did you know that the State has postponed a final hearing, which we are demanding, several times because they have no evidence and no witnesses to report any wrongdoing whatsoever.

You fail to point out that the State has not determined that any false advertising or any other action is improper at all.

The current "restriction" as you call it, is simply to notify patients that the State is of the opinion that the efficacy of RheoTherapy has not been established by well-controlled published clinical studies. We have always educated our patients concerning the experimental nature of the treatment. They do not mind, they are excited to obtain an improvement in their vision.

You are also wrong about the status of clinincal trials. The operative word here is published. Our controlled trial in Germany is readying for publication, and the controlled trial here in the US will be completed in just 3 more weeks.

Numerous presentations of portions of the data have been made, where were you? Haven't you seen the angiograms and fundus photos of patients with resorbing drusen, PED and geographic atrophy. Haven't you seen the case studies of patients with 4, 5, even 6 lines of visual acuity mprovement. If not, I would like to invite you come to our clinic and see for yourself rather than criticizing something about which you obviously have been misinformed. Check us out for yourself, I am sure that you will be impressed.

Also, did you know that the other "restriction" was fulfilled 2 months ago when the State's apheresis expert toured our center and evaluted the RheoTherapy process for safety and found the center to be "exemplary" in every way. The finest he had ever seen. And that there were no safety issues at all. The same was said by Ms. M. Tourault, previously a senior manager with 20 years at FDA's unit regulating blood products.

Finally, no one has ever spent $25,000 for RheoTherapy. Apheresis is an expensive procedure. Hospitals charge $3,000 to $4,000 for comparable procedures. We are proud of the fact that we are the low-cost providers of this technology, and we are spending millions on research to lower the costs even more.

Before you say anything more, I invite you get your facts straight.

Sincerely,
Richard C. Davis MD

Re: RheoTherapy

Posted by Sean on August 17, 1998 at 14:21:56:

I am a 25 year old male and I developed MD a few years ago in my left eye. I have done a lot of research and the only treatment I have found is called RheoTherapy. This is where they filter your blood and sort of "Clean" it. The process has helped many people with MD, but I am very concerned. You see it is a private pay treatment. Insurance co. will not cover it because it is fairly new. 1 treatment costs $2200.00 and the average patient needs between 7 and 10 treatments. I really do not want to waste 20,000.00 on a treatment that might just be a bunch of hype. If anyone has any info on RheoTherapy please let me know or if you are interested in learning a little more about it, the place I contacted was, RheoTherapy Centers 10950 72nd St. Suite 103 Largo,Fl. 33777. There phone # is 1-888-464-7436. But if you have or you know of someone who has had this treatment, please post a message. Thank You.

Posted by Bud Johnson on August 26, 1998 at 23:23:55: In Reply to: RheoTherapy posted by Sean on August 17, 1998 at 14:21:56:

Rumor has it that Occulogix, the outfit that is promoting RheoTherapy, didn't show up at last month's Fort Lauderdale ARVO conference. If RheoTherapy was truly promising, Occulogix would have been well represented.

Bud

Posted by Richard C. Davis MD on August 31, 1998 at 05:10:59: In Reply to: Re: RheoTherapy posted by Bud Johnson on August 26, 1998 at 23:23:55:

Dear Bud,
OccuLogix has been conducting research into RheoTherapy's applications for AMD and other macular diseases for several years. We did not attend the ARVO conference due to conflicting conference schedules and the data from our pilot study, at the University of Utah, had not been completed. That study is concluded now, and the results will be publicized soon. Please be patient. I am certain that you and anyone else concerned with a new treatment for this devastating disease will be excited with these results.

Sincerely,
Richard Davis, MD

Posted by Bud Johnson on September 05, 1998 at 16:02:33: In Reply to: Re: RheoTherapy posted by Richard C. Davis MD on August 31, 1998 at 05:10:59:

For those of us who can read between the lines, the appearance is quite obvious. You do more damage control than you do convincing. Good news travels fast, and good preliminary results are easily recognizable. If RheoTherapy was truly promising, we'd be hearing good things about it from the entire MD community, not just you.

RheoTherapy's profit factor makes you even more suspicious. I was not surprised to read the medical authorities in Florida are invoking due process to shut down your clinic.

When the results are publicized, tell us where we can find them. Hopefully they will be accessible from the web, not just your clinic.

Posted by Richard C. Davis MD on September 14, 1998 at 08:11:14: In Reply to: Re: RheoTherapy posted by Bud Johnson on September 05, 1998 at 16:02:33:

Dear Mr. Johnson,
I wish you were correct about good news traveling fast, however, this is not the usual case in Medicine today. There are many political and economic forces at work that temper the adoption of any new medical technology. The breakthrough drug Herceptin for breast cancer, antibiotics for use in peptic ulcer disease, the development of the MRI machine and a list of hundreds of other "modern miracles" can be cited as examples of breakthroughs that were viciously opposed by vested interests before the courage of a few pioneers overcame the inertia of the prevailing dogma. This path is just a fact of life in this business. In fact, it is the best ideas that are almost always met with the greatest resistance, and it seems to be so in the case of RheoTherapy blood filtration as well. I can only hope that you are willing to seek the facts and see through the rhetoric. If not, you become part of the problem, not part of the solution.

The objective facts here are simple, globally we are approaching our 500th treated patient, and they have done very well. In point of fact, you have never heard of patients disparaging the technology, only praising it. Think about it, any and all opposition has come from just a few very vocal ophthalmologic "powers that be" who have actively resisited the progress of the technology. Aren't you curious about why they do not speak of treatment failures or of safety problems or of any salient point at all. Did you know that each of them has a financial or other vested interest in other funded research activities or in other technologies? Is it so difficult to understand why they might be upset with a promising new therapy like ours?

I am often saddened that this is the case. I mean, here is a devastating disease that afflicts so many (my family as well) and, until RheoTherapy, there has been no treatment, no significant hope of any kind. And now there is hope. None of us may ever know the full extent of the damage that has been done by these short-sighted individuals. I pray for them and especially for their patients who are the ones losing vision.

However, I believe that there is always hope for these people. I am confident that the two upcoming publications of clinical results regarding RheoTherapy blood filtration for its use in AMD will help to change these attitudes about this technology. Five years of work and millions of research dollars have been invested into these studies and we are only weeks away from beginning to publicly unveil their results. I have consistently asked people to be patient, but many have been unable to resist criticizing this technology before having all of the available information concerning it. I often wonder why? You, yourself are critical and yet do not cite examples of treatment failure or poor results or other salient problem with the technology's results to date. I am not sure why, but have faith, you should not be disappointed. (Also, you criticize the company for a "profit factor" although I am not exactly sure what you are referring to. If you could be more specific I will address your issue.)

I also want to clarify your statements about the medical authorities in Florida trying to shut down our clinic. I don't know where you got this information but it is entirely untrue. No actions of any kind have ever been taken by any agency against our clinic. In fact, quite the opposite is true. We have the finest free-standing apheresis center in the country as attested to by inspections by the FDA and the State and others.

If you are referring to the complaint by a small group of vocal opthalmologists lodged against me personally, that is quite another matter. That was a purely political attack that failed miserably last February. In fact, all of those opthalmologists under deposition have recanted every substantive thing that they said concerning any and all facts that prompted the State to take their unprecedented action me. This entire episode was so transparent and so absurd that anyone who can "read between the lines" can easily see what this was all about. I hope you can too.

But you are certainly right. It is a necessary part of my role as CEO of OccuLogix to provide the facts in this situation, and all others relating to the technology, to any an all interested parties who wish to be educated. I gladly accept this responsibility and am pleased by the extensive and growing support we are recieving daily from ophthalmologists and optometrists from all over the country and the world as this technology is being increasingly accepted for its merit.

The time has come for all to recognize the true potential of RheoTherapy Blood Filtration. The political bickering must end. It is childish, destructive and unnecessarily obviscates the issues of its safety and efficacy while untreated millions go blind. Who stands for them? Why is their voice being muffled amidst the drone of the political assault?

We, at OccuLogix, are the patients' advocate. We have had the courage and the foresight to stand up against those who would prefer to maintain the status quo and keep us in the dark ages. We have consistently taken the high road despite all of the abuse, all of the insults and ridicule. Our dedicated researchers, doctors, nurses and staff should be commended for their actions. And in the final analysis will be seen as true heroes in this struggle.

Lastly, the detailed results of our clinical trials will be released through standard peer-reviewed channels. We will provide a synopsis here and on our web site. I hope that your efforts will then be spent in helping educate those in need of this technology since we are each seeking the same objective - better vision for all.

Sincerely,

Richard Davis, MD
Chairman, President and CEO

Posted by Dave Pearce on September 14, 1998 at 17:35:16: In Reply to: Re: RheoTherapy posted by Richard C. Davis MD on September 14, 1998 at 08:11:14:

Dear Dr. Davis,
While I may not be convinced yet that your treatment is the panacea that I and many others have been hoping for, I am not about to crucify you either. I am sure that I am not alone in anxiously waiting to see the results of your testing.

I for one, would like to see the pot shots halted for awhile so that you and your staff may complete the testing reports so that we can all evaluate the results. Then, and only then, I will make up my own mind as to whether this treatment is something that will help me.

Perhaps if you would ignore some of the doubtors, we will not be subject to all of the tic for tac fighting that has been going on too long.

Posted by Richard C. Davis M.D. on September 14, 1998 at 20:55:53: In Reply to: Re: RheoTherapy posted by Dave Pearce on September 14, 1998 at 17:35:16:

Dear Mr. Pearce,
I sincerely appreciate your patience and understanding with the tedious research process. It always seems to take too long and cost too much, but such is life. You are right that I probably do spend too much time attempting to educate those who may have already made up their minds about this technology before they know anything about it, but I watched my grandmother go blind in both eyes from this terrible disease and I sincerely believe that if my efforts can help just one person keep faith that some real hope is emerging, and that that person will see improvement in their vision as a result of RheoTherapy treatment, then all of my trouble will have been worthwhile.

You will not have to wait much longer. Clearly, RheoTherapy is no panacea, however, I am confident that you will not be disappointed with the results once announced. We have come far as you will see.

Sincerely,
Richard Davis, MD
Chairman, President and CEO

RheoTherapy US Clinical Trials Show Promise For AMD Patients

Posted by Richard C. Davis M.D. on December 07, 1998 at 17:37:06:

As many of the regular readers of this bulletin board are aware, RheoTherapy blood filtration for the treatment of AMD has been the subject of considerable debate. Over the past two years, our Company has spearheaded the development of this evolving technology and recently completed the first domestic clinical trial of RheoTherapy using a membrane differential filtration system.

Several months ago, I promised that as soon as the results of this pilot study were available, I would share them with you. The following is a brief summary of the findings from this trial.

I must apologize ahead of time that a detailed report or complete analysis of the study cannot be presented here since the study's researchers are in the process of preparing a full paper for submission for peer review in a major ophthalmologic journal. A release of detailed information would potentially jeopardize the ability to have the paper published. However, if you or your physician would like more information, we have been authorized to discuss the details of the study's results privately and confidentially. Dr. Mark Stern, our National Medical Director, can assist you in this regard and can be reached through the Company's website at occulogix.com or by phone at (813) 639-9616.

[It is very important for all of the readers here to understand that while these results are promising, this pilot study, by design, is too small to make any definite conclusions about the utility of the treatment. The multi-center study planned to begin early next year will be the definitive trial that will be designed to be able to conclusively establish whether the treatment is safe and effective.]

SUMMARY OF THE RHEOTHERAPY PILOT STUDY

IDE TITLE:

"A Double masked, Three-Arm, Randomized Pilot Study Comparing the Safety and Efficacy of RheoTherapy Using Membrane Differential Filtration to Sham Apheresis and No-Treatment Controls for the Treatment of Age-related Macular Degeneration."

INVESTIGATORS:

The study was conducted at the University of Utah Health Sciences Center in Salt Lake City, Utah under IDE # G970241 as promulgated by the U.S. Food and Drug Administration (FDA). The University of Utah's Institutional Review Board provided clearance for human experimentation prior to enrollment. Apheresis treatments (column and circuit) were performed at the Kolff Dialysis Center under the direction of Gary Rabetoy, M.D., Associate Professor of Nephrology, who supervised the medical clearance for all study patients. The randomization and ophthalmologic examinations were conducted at the Moran Eye Center, under the direction of Mano Swartz, M.D., Professor of Ophthalmology. Albert Cheung, M.D., Professor of Hematology and Pathology evaluated the performance of the membrane differential filtration system (the RheoFilter and Plasmaflo MDF system, Asahi Medical Co. Ltd., Tokyo, Japan).

DESIGN:

The study was organized as a prospective, randomized, double-masked, three-arm pilot clinical trial designed to compare the safety and efficacy of RheoTherapy treatment using the RheoFilter MDF system compared to sham column apheresis (Circuit Treatment) and No-treatment Controls.

PATIENTS:

To be eligible, patients had to be between the ages of 50 and 85, have baseline visual acuities between 20/40 and 20/100 (inclusive) with large soft Drusen. Patients with concurrent "Wet" AMD, diabetes, or other retinopathies were excluded from enrollment. Numerous other medical inclusionary and exclusionary criteria further defined the study population.

STUDY:

Thirty eligible patients were randomized into 3 groups of 10 patients each: 1) a Column (RheoTherapy) Treatment Group, 2) a Circuit ("Sham Column") Treatment Group, and 3) a No-Treatment Control Group. Apheresis patients (column and circuit) received 10 protocol apheresis treatments over approximately 16 weeks. Column treatments were performed with the RheoFilter MDF system, Circuit Treatment patients underwent extracorporeal circulation of their blood without the RheoFilter MDF system, and patients in the No-treatment arm were followed with serial examinations over the same period without intervention. Final evaluations were performed two weeks after the final treatment visit. The overall study length was approximately 20 weeks.

All patients underwent a battery of ophthalmologic and laboratory tests. Visual function was measured by statistical analysis of changes across three visual assessment measures over the course of the study. These measures were:

(1) Visual Acuity (best spectacle-corrected visual acuity - BSCVA) - using protocol Early Treatment Diabetic Retinopathy Study (ETDRS) refraction with LogMAR score analysis,
(2) Functional vision changes measured by the Pepper Visual Skills Reading Test (PVSRT) scores, and
(3) Subjective assessments using the VF-14 Questionnaire. (In addition, an AMD Questionnaire was developed and used to corroborate VF-14 findings.)

EFFICACY MEASURES:

One of the study's objectives was to determine whether RheoTherapy treatments could provide patients with "improved vision". "Improved vision" is defined as consistent, significant, correlated improvement measured simultaneously in at least three of the following four visual assessment parameters:

(1) >= 2.5 lines of BSCVA improvement in the Study Eye
(2) >= 2.5 lines of BSCVA improvement in both eyes
(3) > 20% increase in PVSRT scores in at least 1 eye
(4) > 20% improvement the VF-14 Questionnaire

RESULTS:

Visual Acuity - As a group, 40% (8/20) of Column Treatment eyes improved by at least 2.5 lines compared to 15% (3/20) of both Circuit Treatment and 15% (3/20) No-treatment eyes. (Of note: all of the Column Treatment eyes that demonstrated this level of improvement occurred in both eyes of each of four patients. This is true only for one patient in the No-treatment group and none in the Circuit Treatment group. All other acuity changes were isolated and not correlated between both eyes.)

Speed Reading Scores - Column Treatment patients demonstrated 28% increases in median percent change in their speed reading scores compared to decreases of 20% and 23% for Circuit and No-treatment patients, respectively.

Subjective assessment - The Column treatment group had an overall increased mean percent change in VF-14 Questionnaire scores of 19% compared to 2% for Circuit Treatment patients and decreased scores of 10% for the No-treatment group. In addition, 80% (8/10) of Column treatment patients reported improvement in at least 2 areas of the AMD Questionnaire compared to 30% (3/10) of Circuit patients and 0% (0/10) of No-treatment patients.

Therefore, based upon the strict definition of "improved vision", 13.3% (4/30) of the patients studied demonstrated "improved vision". Of significance, 100% (4/4) of the patients who improved received RheoTherapy treatment representing 40% (4/10) of that group. No patients (0%) (0/20) in either of the other two groups "improved". In fact, 20% (4/20) of the No-treatment eyes and 10% (2/20) of the Circuit treatment eyes experienced measurable losses of visual acuity over the course of the study. One No-treatment eye experienced severe vision loss of greater than 3.5 lines of ETDRS acuity. Conversely, 100% (20/20) of the patients' eyes in the RheoTherapy treatment group were documented to either improve or maintain acuity.

Patients' serum concentrations of many rheologic proteins were also evaluated with over 84,000 laboratory values collected and analyzed during the study. Significantly, a positive correlation was independently demonstrated between 'improved vision' and elevated baseline serum levels of four of the rheologic proteins measured. These markers were total cholesterol, HDL cholesterol, IgA and fibrinogen. A higher baseline serum level of any one of these factors was positively correlated with both the probability of improvement as well as the degree of improvement (as measured by total increases in ETDRS line change).

Since only Column Treatment patients improved, it is prudent to look for differences in that group. Of note: of the 10 patients in the Column Treatment group, 50% (5/10) presented with elevated threshold values of at least 3 of these 4 rheologic markers. 80% (4/5) of those patients demonstrated "improved vision", exhibiting total increases in ETDRS line change (sum of both eyes) of 5.5, 6.0, 8.0 and 8.5 lines, respectively. Of note, all (4/4) of the patients who "improved" presented with elevated baseline threshold concentrations in each (4/4) of the rheologic markers independently correlated with "vision improvement". This finding was considered to be highly significant.

SAFETY:

No significant treatment-related adverse events occurred.

CONCLUSION:

Membrane differential filtration shows promise as a safe and effective treatment for select patients with dry AMD and elevated baseline threshold concentrations of certain rheologic markers. Further study is warranted.

* * * *

OccuLogix Corporation is committed to developing RheoTherapy for the benefit of improving vision in patients with AMD and other ophthalmologic conditions. As part of this commitment, we are not only supporting the definitive multi-center study designated "MIRA-I" (Multi-center Investigation of RheoTherapy for AMD) here in the US next year, we are also supporting the "MAC-II" clinical trial that was just begun in Europe evaluating RheoTherapy for the treatment of patients with Wet AMD. Both of these studies should be concluded in about one year. Furthermore, we have just received word from our German partners that the long-awaited MAC-I study results are ready for publication submission.

Amidst all of the clamor over publications and clinical trials, I want to emphasize that we are continuing to provide successful treatments to patients in our clinic here in Largo Florida using the existing first generation apheresis technology available in the US. Since opening one year ago, the RheoTherapyCenters of Tampa Bay has become the nation's largest outpatient apheresis facility. In addition, we have developed more expertise than anyone in the world providing therapeutic exchange treatments for elderly patients.

In closing, I want to state that we appreciate how threatening the introduction of new paradigm technologies can be to both patients and physicians alike and how easy it is to be misunderstood in a vacuum of information, or worse yet, a sea of misinformation.

However, we remain steadfastly committed to a number of fundamental principles. First, we are committed to our patients and the excellence of their care. Second, we are committed to defending our patients' rights to be fully informed and to choose the most appropriate treatment for their condition. Third, we will continue to provide the highest level of excellence in apheresis care and to maintain our leadership role in this exciting field of science and technology. Fourth, we will continue to pioneer the development of office-based apheresis delivery systems so that this technology can become a tool that is readily available for every ophthalmologist to easily and inexpensively incorporate into their private practice. And lastly, we are committed to diligently work to make the treatment more available and increasingly affordable for all who suffer with this debilitating disease.

Through our focused dedication to these objectives and by establishing a growing network of relationships with the finest eye care specialists in the world, OccuLogix is poised to maintain its leadership position in this field for the foreseeable future. Our commitment extends to continue to provide the support necessary to our eye care partners so that they can safely and effectively provide treatment where none was available before. And as part of this objective, we remain committed and prepared to do whatever is within our power to advance the promise of this treatment to provide hope to millions where before there has only been frustration and despair.

With God's blessing and everyone's continued support this vision will soon become a reality.

Sincerely,
Richard C. Davis, Jr., M.D.
Chairman, President and Chief Executive Officer

Christmas Wishes and New Year's plans

Posted by Richard C. Davis M.D. on December 23, 1998 at 16:36:36:

Christmas always gives us time for pause and prayer. A time to give thanks for all that we have and a time to set our sights on those things we seek.

At OccuLogix, our New Year is filled with expectation:

1. We anticipate the start of RheoTherapy's definitive US clinical trial as we look forward to continuing to define a real solution for patients who until now have had few options and little hope for a brighter tomorrow. We anticipate that this multi-million dollar, multi-center study will provide irrefutable evidence of the effectiveness of RheoTherapy as a treatment for many patients with AMD.

2. We anticipate the publication of the results of studies here and abroad in peer-reviewed journals so that the retina community will be able to fully appreciate the significance of the work accomplished thus far, and embrace it for the promise it holds.

3. We have signed the first licensing agreements with some of the nations most respected and influential ophthalmologists who will expand the RheoTherapy technology in over a dozen US cities. And we are in negotiations with over 20 others both here and abroad. Our objective is to provide easier access for patients to obtain treatment as we rapidly expand the role of leading eye-care physicians who wish to incorporate RheoTherapy into their practices.

4. In Europe, we will continue our co-sponsorship of additional studies for other forms of AMD and other ophthalmologic diseases.

With the FDA's help and God willing, 1999 should be a landmark year for real progress in establishing a safe and effective treatment in the US for this dreaded disease.

Best wishes,
Richard C. Davis, MD
Chairman, President and CEO
OccuLogix Corporation

RheoTherapy vs. Apheresis

Posted by Naomi B. Friedman on January 16, 1999 at 17:12:22:

What, if anything, is the difference between RheoTherapy and apheresis done at the blood bank?

Posted by Richard C. Davis Jr., M.D. on January 20, 1999 at 16:35:16: In Reply to: RheoTherapy vs. Apheresis posted by Naomi B Friedman on January 16, 1999 at 17:12:22:

Dear Ms. Friedman,
Thank you for your inquiry. As President of OccuLogix Corporation, the US company researching this technology, I would like to state that there are numerous differences in the application of traditional aphereis procedures done at blood centers and those that we use. These relate primaily to the use of apheresis methods in elderly patients with AMD that we and our partners have developed over the years. Things such as: patient selection criteria, patient education, treatment protocol specifics, clinical endpoints, duration of treatment, followup, and a host of other details have been identified that are unique and proprietary. In fact, the company is seeking patent protection for this, the specifics of which is presently maintained as a trade secret.

If you have any further questions please do not hesitate to contact me or you can contact our web site at occulogix.com.

Sincerely,
Richard Davis, MD

Posted by Fred Vasquez on January 27, 1999 at 06:49:52:

I have recently been diagnosed with Macular degeneration and I have been an avid blood donor and particularly apherasis. My question is, should I stop donating? Thank you for any and all help.

Posted by Richard C. Davis, MD on February 05, 1999 at 03:16:34: In Reply to: Fred Vasquez on January 27, 1999 at 06:49:52:

Dear Mr. Vasquez,
I am unaware of any prohibition against blood donation due to AMD. So I see no reason that you should discontinue your generous gifts.

Sincerely,
Richard Davis, MD

Rheotherapy

Posted by Dan Roberts on April 16, 1999 at 08:31:12: In Reply to: Rheo therapy posted by Mary Ann Morrill on April 15, 1999 at 22:44:29:

I recently heard that Dr. Davis has had some problems in connection with his practice in Florida, and he has left the country. This does not necessarily mean that rheotherapy is an ineffective treatment, but i do think that Dr. Davis was the only one in the U.S. who was promoting it. (By the way, the cost for his treatment, which has not yet been approved by the FDA, is approximately $20,000.)

Posted by Richard Davis, MD on April 20, 1999 at 07:47:42: In Reply to: Re: Rheo therapy posted by Dan Roberts on April 16, 1999 at 08:31:12:

Dear Dan,
It never ceases to amaze me how easily distorted "information" can become in the absence of an investigation of the facts. Actually, a lot of very good things are happening at OccuLogix:

First of all, 'news of my departure from the country is premature'. However, I did attend the Second World Congress for the International Society for Apheresis in Saarbrucken, Germany as one of its featured speakers.

Also in attendance was Dr. Richard Brunner and his group from the Department of Ophthalmology at the University of Cologne which presented the final data from their 5 year MAC-1 study. This is the first public unveiling of their long-awaited data and it conclusively demonstrated the ability of the RheoFilter MDF system to significantly improve the natural course of AMD and improve vision.

By the way, given all of the linguistic nomemclatures in apheresis, a new internationally accepted term; "Rheopheresis" has just been adopted to replace the term 'RheoTherapy' so that as new clinical information is collected from the global research activities underway in this area, scientists will recognize the term and will unambiguously understand its meaning.

Also in the news, our research parners at the Apheresis Research Institute have opened their first commercial Rheopheresis treatment facility in Cologne Germany, and a second is under construction in Majorca, Spain. A Mr. Harris from California was referred by us, and is currently receiving treatment as the first American to obtain treatment at the new facility. I understand that he is very pleased with the results thus far.

Furthermore, along with Asahi Medical and Diamed Medizinetecknik GmbH, Occulogix is participating as a co-sponsor in the MAC-2 clinical trial studying the use of Rheopheresis in patients with wet AMD. The study is being conducted at the University of Frankfurt and began enrollment in February.

Of particular note, Dr. Klaus Heimann, the Director of the Department of Ophthalmology at the University of Cologne recently proclaimed that Rheopheresis is no longer considered experimental in Germany. The work underway now is to obtain widespread acceptance and reimbursement. (By the way, Dr. Heimann is a retina specialist and studied under Dr. Don Gass, the ledgendary US retina surgeon, now semi-retired at Vanderbilt.)

Dan, regarding the comment about the actions by the State of Florida regarding my medical license, it all looks pretty silly at this point don't you think? Even those ophthalmologists who initiated the political opposistion against the technology are now eager to see the results of the upcoming definitive trial. In fact, most of them have asked to participate in MIRA-1, but all of the study sites had already been identified.

From our perspective, there appears to be a whole new wave of optimism among ophthalmologists in the know concerning Rheopheresis treatment. The Company's research and education efforts are beginning to take hold as scientists, physicians and the general public at large are beginning to undersatnd the nature of apheresis science and embrace its possibilities.

With respect to the suspension of treatment at the Rheotherapy Centers of Tampa Bay, the FDA asked the Company to change its research format and complete the study of RheoTherapy using therapeutic plasma exchange (TPE) under an IDE prior to continuing to enroll any new patients. Since we are already in the definitive multi-center IDE study for the RheoFilter MDF system and have committed a significant portion of the Company's research resources in that direction, we elected to procede with MIRA-1 as the Company's exclusive domestic research focus at this time. This is especially reasonable since the new RheoFilter MDF technology is going to make TPE obsolete for the treatment of AMD! MDF offers significant cost, safety and patient care advantages with no down-sides compared to the TPE technology we are phasing out. As with most new state-of-the-art selective plasma membrane filters, the RheoFilter MDF system represents the apheresis technology of the future.

The definitive FDA study I referred to above is titled "MIRA-1": the Multi-center Investigation of Rheopheresis for AMD. Coincidently, in Spanish, the word mira means "see".

We expect approval from the FDA to begin MIRA-1 any day now. I will keep you and your members informed on the progress of the study, so we can work together to let patients know where they can get enrollment information as the investigational sites become activated.

As with all of the previous US trials, MIRA-1 is being financed by OccuLogix, and Rheopheresis treatment will be completely free to all qualified enrolled patients.

The study will entail 8 Rheopheresis treatments over a period of about 2 months, with follow up for about 1 year.

Dan, I applaud your work in this area and appreciate your continued interest in Rheopheresis and its application to AMD.

Sincerely,
Richard Davis, MD
Chairman, OccuLogix Corporation

Richard C. Davis, MD on April 27, 1999 at 03:34:28: In Reply to: Re: Rheo therapy posted by Dan Roberts on April 23, 1999 at 20:14:14:

Dan,
Last Wednesday the FDA approved our application to enter the multi-center pivotal clinical trial to obtain approval for the RheoFilter MDF system for the treatment of AMD. They found the data from the pilot study at the University of Utah very compelling.

As soon as we finalize the clinical sites, I will let you know where patients can call to see if they may be eligible.

Thanks,
Richard Davis, MD

FDA authorizes new study to begin for Dry AMD

Posted by Richard C. Davis, Jr. MD on October 12, 1999 at 00:47:29:

MIRA -1 Clinical Trial

Multi-center Investigation of Rheopheresis for AMD

Background: Last year, a 30 patient IDE pilot study, sanctioned by the FDA, conducted at the University of Utah, demonstrated that certain patients with non-exudative age-related macular degeneration and elevated blood levels of certain lipids and macroproteins experienced significant improvement in their visual symptoms when they underwent a series of therapeutic apheresis treatments using an investigational membrane differential blood filtration procedure (Rheopheresis™ blood filtration). In addition, the results of the MAC-1 Trial (a 40-patient, randomized prospective study in Germany) were recently presented that concluded that Rheopheresis safely and effectively improved vision in AMD patients. No serious treatment-related adverse events were reported in either study.

MIRA-1 Study Design: In the current multicenter FDA study, 8 investigational sites will be enrolling up to a total of 180 patients to be randomized into 2 groups. 120 patients will be enrolled in the treatment group, and 60 patients will be enrolled into a placebo comparison group. Patients will receive 8 treatments (actual or placebo) and the results between the groups will be compared after 3, 6, 9 and 12 months of follow-up. If the treatment is determined to be successful, all placebo patients will be offered treatment at no cost.

Study Treatments: Treatments will consist of establishing two IV lines, one in each forearm. The patient's blood will be routed through a microprocessor-controlled apheresis-pumping device containing two blood filters. The first filter separates the plasma from the whole blood and directs the plasma to the second filter. The second filter sieves high molecular weight lipids and proteins (example: LDL cholesterol, a-2 macroglobulin, fibrinogen and others). The macroprotein-depleted plasma is combined with the patient's own blood cells and the reconstituted whole blood is pumped back into the patient through a sterile closed circuit. The entire procedure is essentially painless and takes about 2 hours. Patients get only their own blood back, and no anesthesia is required. Placebo treatments consist of venipunctures only where the patient's blood is not circulated through the filters.

Rationale: The proposed mechanism of action is that the removal of certain high molecular weight proteins and lipids has a number of synergistic effects including: (1) reduction of plasma viscosity; (2) improvement of capillary blood flow; (3) enhancement of endothelial cell function; and (4) improvement of choriocapillary perfusion, each of which is postulated to lead to improved photoreceptor functioning and better vision.

Criteria for entry into the study:

Inclusionary Criteria:

• Patients of any race between the ages of 50 and 85 years inclusive.

• Eyes must have a diagnosis of non-exudative Age-Related Macular Degeneration with > 10 large soft drusen 63 µm in diameter, within 3,000 µm of the foveal center.

• Eyes must have a BSCVA using the ETDRS chart between 20/32 and 20/125 inclusive.

• Patients must have elevated baseline concentrations of 2 of the following 3 rheologic factors:

  1. total serum cholesterol greater than or equal to 200 mg/dl;

  2. a serum fibrinogen level of greater than or equal to 300 mg/dl, or

  3. a serum immunoglobulin A (IgA) level greater than or equal to 200 mg/dl.

• Patients must have a score of no more than 75 on the VFQ-25 Visual Functioning Questionnaire (NEI).

• Eyes must not have conditions that limit the view of the fundus (e.g. vitreous hemorrhage, cataracts, and epiretinal membrane). The degree of lens opacification will be evaluated using the LOCS III system. All patients with greater than or equal to 2+ nuclear opacities and/or significant central opacity (PSC or ASC) greater than or equal to 1+ will undergo Potential Acuity Meter (PAM) testing. If the vision is greater than or equal to 2 lines improved on PAM over standard acuity measurement then the patient will not be eligible for the study.

• Patients must have normal PT & PTT clotting times with the exception of stable patients taking Coumadin at the discretion of the Investigator.
  o Patients must have adequate bilateral antecubital venous access.
  o Patients taking any lipid-lowering medication at the beginning of the treatment phase must agree to continue to take them throughout the treatment phase using their current regimen. Patients not taking lipid-lowering medication must agree to not begin taking any such medication until the conclusion of the treatment phase to avoid confounding of the treatment effect measurement.

• Patients must be available for minimum study duration of approximately 12 months and be willing to make 14 clinic visits during this period.

• Patients must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent.

• Patients must agree to discontinue their current vitamin regimen (including all vitamins, minerals, multivitamins and other ocular-health related supplements) and to substitute their regimen with a uniform supplement regimen provided by the study sponsor.

Patients or eyes must not meet any of the exclusion criteria below.

Exclusionary Criteria:

• Eyes with concomitant retinal or choroidal disorders other than AMD or with indefinite signs of AMD.

• Eyes with significant central lens opacities causing vision decrease.
  o Eyes with a diagnosis of exudative "Wet" Age-Related Macular Degeneration with active subretinal neovascularization (SRNV) or active CNV lesions requiring laser photocoagulation.

• Eyes with optic nerve disease (neuropathy, atrophy, papilledema), potentially occludable anterior chamber angles, unstable glaucoma, history of retina-vitreous surgery, degenerative myopia; active posterior intraocular inflammatory disease, chronic use of steroidal eye medications, vasoproliferative retinopathies (other than AMD), rhegmatologous retinal detachment, and inherited macular dystrophies.

• Patients that are in poor general health, have unstable diseases, are terminally ill, have a life expectancy of less than 12 months, are non-ambulatory or bedridden, live in a geographical location which would likely prevent regular attendance at study visits or are considered not suitable for participation by the investigator.

• Patients with a hematocrit <35%, evidence of active bleeding (e.g. hemorrhaging), a platelet count <100,000 K/uL, a prolonged PT/PTT (unless the patient is taking Coumadin) or significant coagulapathies as determined by the investigator.

• Patients with significant cardiac problems such as unstable angina pectoris, severe congestive heart failure or clinically symptomatic hypotension, etc.

• Patients with uncontrolled hypertension as determined by the investigator and the patient's primary physician.

• Patients with a recent history (within the previous year) of cerebral vascular disease manifested with transient ischemic attacks (TIA's) or cerebral vascular accidents (CVA's).

• Patients with severe hepatic failure, renal failure, pulmonary disease or diabetes.

• Patients with a history of HIV infection, AIDS, hepatitis B or C, or other immunosuppressive disorders.

• Patients allergic to Fluorescein sodium and indocyanine green (ICG), the dyes which are commonly injected intravenously during retinal angiography or allergic to Heparin, ACDA, local anesthetics or adhesive tape

• Patients who are pregnant or breastfeeding.

• Patients exposed to an investigational device or drug within the past 30 days or involved concurrently in other treatment clinical trials. Note: Patients involved with a "natural history" AMD clinical trial are eligible to participate in this study

• Patients unwilling to adhere to visit or examination schedules as described in the study protocol.

• Patients with a known history of alcoholism, drug abuse, psychosis, clinical evidence of depression, poor motivation, emotional or intellectual problems, or any other conditions which would likely limit validity of consent or appropriate responses to participate in the study or who are deemed unsuitable psychologically or physiologically for study participation by the investigator.

If you would be interested in and may qualify for this study, please contact the study sites listed below so that we may begin the screening and evaluation process.

Study Sites: Some of the country's leading retina specialists are overseeing MIRA-1 in the following cities:

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