TORONTO, ONTARIO--(CCNMatthews - June 12, 2006) - OccuLogix, Inc. (NASDAQ:RHEO)(TSX:RHE) today announced that representatives of the Company met with the U.S. Food and Drug Administration (“FDA”) on June 8, 2006 to discuss the results of MIRA-1, the Company’s recently completed clinical trial using its RHEOTM System to treat the dry form of age-related macular degeneration, and the impact those results will have on its application to market its RHEOTM System in the United States.
As expected, at the meeting, the FDA advised that it would require an additional study of the RHEOTM System to be performed. Accordingly, the Company expects to submit its application for an Investigational Device Exemption (“IDE”) with a new protocol to the Agency within the next 60 days. Details of the new study will be released when the IDE is filed by the Company and accepted by the FDA.
Elias Vamvakas, OccuLogix’s Chairman & CEO, commented, “We had a very positive and constructive meeting with the Agency and gained some valuable clarity on the regulatory pathway for the RHEOTM System. The FDA also indicated its willingness to allow the substitution of the new polysulfone RheofilterTM for the older cellulose acetate filter in the upcoming study. This removes the regulatory uncertainties presented by making the substitution following FDA approval and eliminates the need to continue to build and maintain adequate inventories of the older filter in preparation for commercial launch.”
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.