FDA and OccuLogix Agree on Statistical Analysis & Filing Plans

Business Wire, Oct 11, 2005

TORONTO -- OccuLogix, Inc. (NASDAQ:RHEO)(TSX:RHE) today announced that the U.S. Food and Drug Administration ("FDA") and the Company have agreed on a Statistical Analysis Plan and a Filing Plan with respect to the clinical module of OccuLogix's Pre-Market Approval Application ("PMA") for its RHEO(TM) System.

In the fourth quarter of 2004, the Company submitted to the FDA the first three of four modules of its PMA filing. These modules contained non-clinical results of bench tests and quality assurance, and documented manufacturing processes on the components of the RHEO System.

In December 2004, OccuLogix also completed enrollment for participation in MIRA-1, its pivotal (phase III) stage clinical trial using its RHEO System to treat the dry form of age-related macular degeneration ("Dry AMD"). MIRA-1 is a multi-center, randomized (2:1), double-masked and placebo-controlled trial designed to evaluate the safety and efficiency of RHEO Therapy in patients with intermediate-to-late stage, or Category 3 and Category 4, Dry AMD.

Elias Vamvakas, OccuLogix's Chairman and CEO, commented "In order to satisfy new FDA rules designed to help reduce pre-market review times, the Company has elected to file only one PMA clinical module following completion of twelve-month data collection, subject unmasking and analysis on at least 150 MIRA-1 patient data sets. With 135 patients having already completed their 12-month follow-up exams at the end of September 2005, and with all remaining 12-month follow up exams scheduled to take place before year-end, we remain on track to submit that final module of our PMA in the first quarter of 2006."

About OccuLogix, Inc.

OccuLogix is a health care company that brings innovative and evidenced-based medical therapies to market. OccuLogix's common shares trade on the NASDAQ National Market under the symbol 'RHEO' and on the Toronto Stock Exchange under the symbol 'RHE'. Visit us on the internet at www.occulogix.com (corporate) and www.rheo.com (healthcare professionals, patients and caregivers).

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 regulatory authorities, including our Registration Statement on Form S-1. We do not undertake to update any forward-looking statements.

OccuLogix, Inc. (NASDAQ:RHEO) (TSX:RHE)