IRVINE, Calif., Sept. 16 /PRNewswire/ — ISTA Pharmaceuticals,
Inc. (Nasdaq:
ISTA), today announced that it has initiated a Phase 3 clinical
program of ISTA’s proprietary formulation of REMURA™
(bromfenac ophthalmic solution for dry eye) for alleviating the
signs and symptoms of dry eye disease. The Phase 3 efficacy studies
are being conducted under a Special Protocol Assessment (SPA)
agreed upon with the U.S. Food and Drug Administration (FDA).
“We are pleased by the initiation of our pivotal REMURA dry eye
efficacy program. Further, reaching agreement with the FDA on the
SPA for REMURA efficacy studies provides additional clarity
regarding the path to approval, which will help us to bring a safe
and effective treatment to patients suffering from dry eye,” stated
Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of
ISTA. “Dry eye is a large and growing market, with 2010
worldwide prescription sales expected to be about $600 million.
Dry eye also is an underserved market, as patients suffering
from chronic dry eye syndrome have few quality therapy options.
We are very excited by the potential of REMURA as a new
treatment modality for dry eye patients.”
At this time, ISTA plans to assess the safety and efficacy of
REMURA in alleviating the signs and symptoms of dry eye disease by
conducting four randomized, double-masked, placebo-controlled Phase
3 studies. The recently initiated Phase 3 studies will evaluate the
efficacy and safety of bromfenac in two simultaneous studies
operating under a common protocol in approximately 1000 patients
with mild or moderate dry eye disease. The multi-center trials will
be conducted at more than 30 sites in the U.S. Two concentrations
of bromfenac (both lower than the currently marketed Xibrom
(bromfenac ophthalmic solution)® 0.09%), will be dosed in
addition to placebo. Patients will be ra
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