Monday June 12, 8:40 am ET TORONTO, ONTARIO--(MARKET WIRE)--Jun 12, 2006 -- OccuLogix, Inc. (NasdaqNM: RHEO )(TSX:RHE.TO) 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 RHEO(TM) System to treat the dry form of age-related macular degeneration, and the impact those results will have on its application to market its RHEO(TM) System in the United States.
As expected, at the meeting, the FDA advised that it would require an additional study of the RHEO(TM) 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 RHEO(TM) System. The FDA also indicated its willingness to allow the substitution of the new polysulfone Rheofilter(TM) 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). <<
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