OccuLogix, Inc.

OccuLogix, Inc.

February 28, 2005 08:45 ET

OccuLogix Receives FDA Clearance to Initiate MIRA-1 Crossover Studies


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: OCCULOGIX, INC.

NASDAQ SYMBOL: RHEO
TSX SYMBOL: RHE

FEBRUARY 28, 2005 - 08:45 ET

OccuLogix Receives FDA Clearance to Initiate MIRA-1
Crossover Studies

TORONTO, ONTARIO--(CCNMatthews - Feb. 28, 2005) - OccuLogix, Inc.
(NASDAQ:RHEO)(TSX:RHE) today announced that the U.S. Food and Drug
Administration ("FDA") has completed a review of the Long-term Efficacy
in AMD from Rheopheresis in North America ("LEARN") protocols submitted
to it by OccuLogix on January 21, 2005, and has given OccuLogix
permission to initiate the studies.

MIRA-1 Background

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.

Recently, OccuLogix completed enrollment of 185 patients for
participation in MIRA-1, its pivotal (phase III) stage clinical trial
using its RHEO System to treat Dry AMD. MIRA-1 is a randomized (2:1),
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. 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. If successful, MIRA-1 is expected to
support OccuLogix's application with the FDA to obtain approval to
market the RHEO System in the United States.

Crossover Studies

LEARN-1 is an open-label multi-center study that will enroll up to 120
subjects who have completed the "treatment arm" of the MIRA-1 study.
There will be up to 12 investigational sites where the subjects will be
randomized in a 1:1 fashion to receive either two (2) or four (4) RHEO
Therapy "booster" procedures, and the results between the groups will be
compared after 3, 6, 9, and 12 months of follow-up from baseline.

LEARN-2 is an open-label multi-center study that will enroll up to 60
subjects who have completed the "placebo arm" of the MIRA-1 study. There
will be up to 12 investigational sites where the subjects will receive
eight (8) RHEO Therapy procedures and will have a 3, 6, 9 and 12 month
follow up from baseline evaluation.

Subjects in both LEARN-1 and LEARN-2 must continue to have at least one
eye with Dry AMD and be in good general health.

"We expect to launch patient screening for inclusion in the two
crossover studies in the second quarter of this year," said Elias
Vamavakas, OccuLogix's Chairman and CEO.

Vamvakas concluded, "While the results will not be included in our PMA
application with the FDA, we believe that the additional knowledge
gained from LEARN-1 and LEARN-2 will prove to be extremely valuable. For
example, when enrollment in the crossover studies commences this Spring
from amongst the first group of 85 MIRA-1 patients who completed either
their treatment or placebo arms, up to, and in many cases more than, 5
years will have passed since they had their original baseline examines.
It will be fascinating to see how the treated patients faired relative
to the placebo patients in the progression of their disease over the
long-term."

About OccuLogix, Inc.

OccuLogix is an ophthalmic therapeutic company founded to commercialize
innovative and evidence based 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