TAMPA, Fla., June 24 — Sirion Therapeutics, Inc., a
privately held ophthalmic-focused biopharmaceutical company, announced
today that the U.S. Food and Drug Administration (FDA) has approved its new
drug application for Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%,
a topical steroid for the treatment of postoperative ocular inflammation
and pain. The approval came after a six month priority review.
“Durezol, our first product to be approved by the FDA, is a potent
topical steroid that works rapidly and effectively to resolve postoperative
inflammation and pain,” said Barry Butler, President and CEO of Sirion
Therapeutics, Inc. “We look forward to launching the first innovation in
the strong steroid class in more than 35 years, and the first steroid to
have an indication for the treatment of postoperative pain. We believe that
having access to a steroid that treats both inflammation and pain gives
physicians a more complete treatment approach.”
In two Phase 3 trials evaluating Durezol in patients diagnosed with
significant postoperative inflammation (more than 10 anterior chamber
cells), Durezol rapidly reduced inflammation and pain. Mean intraocular
pressure (IOP) for all study groups remained within the normal range
throughout the study.
“Rapid resolution of inflammation and pain is very important following
ocular surgery,” said Dr. Michael Korenfeld, M.D., Assistant Clinical
Professor of Ophthalmology and Visual Sciences, Washington University, St.
Louis, MO, and principal investigator for the Phase 3 trials. “It is
important to point out that in these Phase 3 studies, patients were dosed
for the first time after the ocular trauma from surgery had occurred. The
results from these studies, particularly the ability to eliminate
postoperative pain demonstrate that Durezol is a powerful option for
postoperative care.”
Sirion Therapeutics plans to make Durezol commercially available in
late 2008.
Phase 3 Program Results
The two U.S. Phase 3 multi-center studies evaluated the safety and
efficacy of Durezol compared to placebo dosed twice a day (BID) and four
times a day (QID) beginning 24 hours after intraocular surgery. Treatment
occurred over 4 weeks and included tapering. The studies included 438
subjects who presented with significant inflammation as evidenced by an
anterior chamber cell grade 2 or higher (greater than 10 cells) the day
after surgery.
Both regimens (BID and QID) had similar overall efficacy in the
reduction of anterior chamber cells two weeks following surgery (86% in BID
and 87% in QID). The QID regimen had a small numerical advantage in the
number of patients who were completely free of inflammation and pain at the
one week time point. Because of this numerical advantage, and the desire to
treat inflammation aggressively, the QID dosing regimen was chosen for
recommendation to doctors.
Durezol was well tolerated with few treatment related adverse events.
One of the most common side effects seen with steroids in ophthalmic use is
a rise in IOP. Three percent of subjects in each of the BID and QID groups,
and one percent of subjects in the placebo group met the criterion for a
clinically significant rise in IOP, defined as an observed value of greater
than or equal to 21 mm Hg and a change from baseline of 10 mm Hg.
About Postoperative Inflammation
More than five million ophthalmic surgeries are performed each year in
the United States. Postoperative inflammation and pain are common
occurrences following these procedures and if left untreated, can interfere
with a patient’s visual rehabilitation or lead to further complications.
Corticosteroids and non-steroidal anti-inflammatory drugs are commonly used
by healthcare professionals following ophthalmic surgery.
About Durezol
Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical
ophthalmic corticosteroid for the treatment of postoperative inflammation
and pain associated ocular surgery. Durezol is a difluorinated derivative
of prednisolone and has potent anti-inflammatory activity. Prior to U.S.
approval, the efficacy and safety of Durezol in ocular inflammatory
diseases had been demonstrated in an extensive preclinical and clinical
program in Japan.
Two Phase 3b studies evaluating Durezol for the management of
inflammation and pain after intraocular surgery have been completed in
which Durezol treatment was initiated one day prior to surgery. Durezol is
also being studied in other ocular inflammatory diseases, including a U.S.
Phase 3 study evaluating Durezol for the treatment of anterior uveitis.
About Sirion Therapeutics, Inc.
Sirion Therapeutics is a privately held biopharmaceutical company
pursuing the discovery, development, and commercialization of products
addressing unmet medical needs in the protection and preservation of
eyesight. Sirion’s product portfolio includes: Durezol, a topical steroid
for postoperative inflammation and pain and in development for uveitis;
ganciclovir, a topical antiviral in development for herpetic keratitis;
cyclosporine, a topical immunomodulator in development for dry eye; and
fenretinide, a first-in-class oral vitamin A binding protein antagonist in
development for geographic atrophy associated with dry AMD. For more
information, please visit http://www.siriontherapeutics.com .
SOURCE Sirion Therapeutics, Inc.