OccuLogix, Inc.
NASDAQ : OCCX
TSX : OC

OccuLogix, Inc.

January 29, 2007 07:45 ET

OccuLogix's RHEO-AMD Trial Protocol Cleared by the FDA

Patient Recruitment Expected to Commence Later This Quarter

TORONTO, ONTARIO--(CCNMatthews - Jan. 29, 2007) - OccuLogix, Inc. (NASDAQ:OCCX) (TSX:OC) today announced that it has obtained Investigational Device Exemption clearance from the U.S. Food and Drug Administration ("FDA") to commence its pivotal (phase III) study of the RHEO™ procedure to treat the Dry form of Age-Related Macular Degeneration ("Dry AMD").

The new study, called RHEO-AMD, is a multi-center, prospective, randomized (2:1), double-masked, sham-controlled trial designed to evaluate the safety and efficacy of the RHEO™ procedure in patients with intermediate-to-late stage Dry AMD. If successful, RHEO-AMD is expected to support OccuLogix's application to the FDA for approval to market its RHEO™ System in the United States.

Each patient in RHEO-AMD will receive either eight RHEO™ treatments or eight sham procedures over ten weeks. Patients will be followed to evaluate any sustained benefit of the treatment for the RHEO™ procedure population and the continuing natural course of vision change in the sham population. The study's primary endpoint is the mean change from baseline to 12-months in Best Corrected Visual Acuity applying the Early Treatment Diabetic Retinopathy Scale ("ETDRS BCVA"). Secondary and tertiary endpoints include changes from baseline to 12-months in the National Eye Institute's Visual Function Questionnaire-25, responder analysis of differences between active and sham groups on the gain and loss in ETDRS BCVA of greater than 5 letters (1 line), 10 letters (2 lines) and 15 letters lines (3 lines), and improvement to 20/40 or better.

The study will take place at up to 25 ophthalmic sites. The trial's external monitor will be The EMMES Corporation, a leading contract research organization with extensive experience in ophthalmic studies. The reading center for RHEO-AMD will be the Digital Angiography Reading Center (DARC), the first fully digital reading center for the evaluation of ophthalmic images.

Elias Vamvakas, OccuLogix's Chairman and CEO, commented, "Drawing upon important lessons learned from the analyses of MIRA-1, the new RHEO-AMD protocol was designed in close consultation with our Retinal Scientific Advisory Board and with the FDA. We are confident that a successful new study will lead to FDA approval of the RHEO™ procedure."

Allen C. Ho, MD, a Professor of Ophthalmology at Wills Eye Institute and a member of OccuLogix's Retinal Scientific Advisory Board, said, "I believe that my colleagues in the ophthalmic community are very supportive of this new study, especially in light of the RHEO™ procedure's excellent safety profile to-date and the current lack of treatment options for Dry AMD patients."

Peter K. Kaiser, MD, a RHEO-AMD ophthalmic investigator from the Cole Eye Institute and a member of OccuLogix's Retinal Scientific Advisory Board, said "While there have recently been some very significant advances in the treatment of Wet AMD, the Dry form of the disease continues to represent a larger and growing unmet medical need. Regardless of outcome, the RHEO-AMD study is well designed and has attracted top retinal trial sites and investigators - the results will be believable."

About AMD

Age-related macular degeneration causes damage to the macula - the light-sensitive cells at the center of the retina at the back of the eye. The macula is responsible for our ability to see with enough detail to read, drive, watch television and perform other activities that require focused, straight-ahead vision, as well as providing information that allows us to perceive colors; thus, allowing one to maintain independence in daily activities.

There are two types of AMD - "dry", or non-exudative, and "wet", or exudative. Dry AMD, the most common form of the disease, currently afflicts approximately 13.0 to 13.5 million people in the United States, representing approximately 85% to 90% of all AMD cases in the country. Currently, there is no FDA approved treatment for Dry AMD.

About the RHEO™ Procedure

The RHEO™ procedure is a specific method of apheresis - a treatment in which a patient's blood is drawn outside the body and specific compounds are removed before being returned to the body. Apheresis, which is similar in principle to blood donation, has been used for decades to treat a variety of illnesses, including excessively high cholesterol and rheumatoid arthritis.

Japanese scientists developed the basis for the RHEO™ procedure in the 1970s while looking for a way to treat high cholesterol. About 10 years later, researchers at the University of Cologne in Germany used a newly developed filter, today called the RHEO™ filter, in a treatment study for eye conditions characterized by impaired microcirculation of the retina. The treatment was especially successful in patients who had AMD. Based on those results, experts conducted years of clinical research in order to further develop the RHEO™ procedure into a treatment for Dry AMD.

About OccuLogix, Inc.

OccuLogix is building a leading company focused on evidence-based ophthalmic devices for the diagnosis and treatment of age-related eye diseases. Visit us on the internet at www.occulogix.com (corporate). Additional information on the Company's RHEO™ procedure to treat Dry AMD can be found at www.rheo.com. To learn more about the Company's SOLX® Gold Shunt and SOLX® 790 Laser for the treatment of glaucoma, please visit www.solx.com or www.deeplightsystem.com.

Forward-Looking Statements

This press release may contain forward-looking statements. These statements relate to future events and are subject to risks, uncertainties and assumptions about the Company. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement, including the factors detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Forms 10-K and 10-Q. We do not undertake to update any forward-looking statements.

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