OccuLogix, Inc.

OccuLogix, Inc.

January 03, 2005 08:15 ET

OccuLogix's Pivotal Trial for Dry Age-Related Macular Degeneration Exceeds Patient Recruitment Goal


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: OCCULOGIX, INC.

NASDAQ SYMBOL: RHEO
TSX SYMBOL: RHE

JANUARY 3, 2005 - 08:15 ET

OccuLogix's Pivotal Trial for Dry Age-Related Macular
Degeneration Exceeds Patient Recruitment Goal

TORONTO, ONTARIO--(CCNMatthews - Jan. 3, 2005) -

Company Also Confirms the Filing of PMA Modules 1, 2 and 3 with the U.S.
FDA

OccuLogix, Inc. (NASDAQ:RHEO)(TSX:RHE) announced today that it has
enrolled 185 patients for participation in a pivotal (phase III) stage
clinical trial using its RHEO System to treat the dry form of
age-related macular degeneration, exceeding its goal of 180 patients.
AMD is the leading cause of late onset visual impairment and legal
blindness in people over the age of 50. 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.

Although the precise cause of AMD is not known, researchers have
identified several factors that are associated with the disease,
including poor micro-vascular circulation and the gradual build-up in
the retina of cellular waste material called drusen. OccuLogix's RHEO
System is being evaluated to determine whether it will improve
micro-vascular circulation in the eye by filtering high molecular weight
proteins and other macromolecules from the patient's plasma through a
treatment process known as Rheopheresis.

MIRA-1, or Multicenter Investigation of Rheopheresis for AMD, is a
randomized, 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. If successful, MIRA-1 is expected
to support OccuLogix's application with the U.S. Food and Drug
Administration to obtain approval to market the RHEO System in the
United States.

Each patient in MIRA-1 receives either eight RHEO Therapy or eight
placebo procedures respectively over ten weeks. The study's primary
endpoint is the mean change in Best Spectacle-Corrected Visual Acuity
applying the Early Treatment Diabetic Retinopathy Scale ("ETDRS BCVA").
Secondary and tertiary endpoints include legal driving, vision
improvement, vision loss, drusen reduction and progression to legal
blindness.

"As of December 31, 2004, we had enrolled a total of 185 patients in
MIRA-1 with the goal of obtaining at least 150 complete 12-month data
sets," said Elias Vamvakas, OccuLogix's Chairman and CEO.

Vamvakas continued, "In fact, completion of patient enrollment is the
second major milestone our company has met in the past two weeks. In
December 2004, we also submitted to the FDA the first three of four
modules of our 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."

Success in treating AMD is often only measured by the ability to slow
down or halt the disease's progression. However, with respect to the
first 43 patients in the MIRA-1 study, the twelve-month intent-to-treat
interim analysis showed that eyes treated with Rheopheresis demonstrated
a mean vision gain of 0.74 lines of ETDRS BCVA at 12 months
post-baseline, compared to a mean vision loss of 0.87 lines of ETDRS
BCVA in the eyes in the Placebo group (p equals 0.001). With respect to
the subgroup of 28 patients with worse than legal driving vision, or a
BCVA of worse than 20/40, prior to enrolling in the trial, the
twelve-month intent-to-treat interim analysis showed that eyes treated
with Rheopheresis demonstrated a mean vision gain of 1.1 lines of ETDRS
BCVA at 12 months post-baseline, compared to a mean vision loss of 1.9
lines of ETDRS BCVA in the eyes in the Placebo group (p equals 0.001).
In addition, 57.9% of Rheopheresis-treated eyes in the subgroup improved
after treatment to 20/40 or better and continued to qualify for a
driver's license 12 months post-baseline.

"With the achievement of the milestones announced today, our excitement
continues to grow about the potential Rheopheresis represents in
delivering hope for the first time to the millions of people suffering
from this devastating disease," concluded Vamvakas.

About OccuLogix, Inc.

OccuLogix is an ophthalmic therapeutic company founded to commercialize
innovative treatments for eye diseases, including age-related macular
degeneration. AMD is the leading cause of late onset visual impairment
and legal blindness in people over the age of 50. OccuLogix's common
shares trade on the NASDAQ National Market under the symbol 'RHEO' and
on the Toronto Stock Exchange under the symbol 'RHE'.

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.

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Contact Information

  • FOR FURTHER INFORMATION PLEASE CONTACT:
    OccuLogix, Inc.
    Stephen Kilmer
    VP, Corporate Affairs
    (905) 602-0887 ext. 3904
    stephen.kilmer@occulogix.com