Sirion Therapeutics, Inc.
Studies of Treatments for Leading Causes of Blindness to Be Presented
TAMPA, FL, November 3, 2008 – Sirion Therapeutics, Inc., a privately held ophthalmic-focused
biopharmaceutical company, announced today that studies of two investigational drugs in
development for treatment of potentially blinding eye diseases will be presented at upcoming
ophthalmology meetings: At the American Uveitis Society’s annual invitational meeting
(November 9, Atlanta Marriott Marquis, Atlanta), preliminary results will be presented from an
anterior uveitis trial that compared Sirion’s ophthalmic corticosteroid Durezol™ (difluprednate
ophthalmic emulsion) 0.05% dosed four times daily (QID) to Pred Forte
®
* (prednisolone acetate
ophthalmic suspension) 1%, dosed eight times daily. Durezol was approved by the US Food and
Drug Administration in June 2008 for the treatment of inflammation and pain associated with
ocular surgery.
In addition, data for Sirion’s ophthalmic gel formulation of ganciclovir as a treatment for herpetic
keratitis will be presented in a poster at the American Academy of Ophthalmology (AAO) Meeting
(November 8-11, Atlanta). The poster’s author is Herbert E. Kaufman, M.D., Ophthalmologist
Emeritus of Sirion Therapeutics and formerly Professor of Ophthalmology and Pharmacology and
Head of the Department of Ophthalmology at LSU Medical Center, and past president of the
Association for Research and Vision in Ophthalmology (ARVO), the International Society of
Refractive Surgery (ISRS) and the Contact Lens Association of Ophthalmologists (CLAO).
“We’re proud to have products in late-stage clinical testing for two of the leading causes of
blindness, uveitis and ocular herpes,” said Barry Butler, President and CEO of Sirion
Therapeutics, Inc. “These medications have the potential to reduce suffering and save the vision
of thousands of patient each year, and exemplify our mission to address unmet medical needs in
the protection and preservation of eyesight.”
The results of the Durezol uveitis study will be presented by investigator Thomas Flynn, M.D.,
Assistant Professor of Clinical Ophthalmology, Columbia University, and Ellsworth Uveitis &
Retina Care, in his presentation, “Durezol Compared to Pred Forte in the Treatment of
Endogenous Anterior Uveitis.” The randomized, multicenter, double-masked trial included 90
subjects with endogenous anterior uveitis having >10 cells and a flare score of ≥ 2 in the anterior
chamber (AC). In the study, Durezol administered QID was as effective as Pred Forte dosed eight
times a day in treating uveitis. Durezol was also safe and well tolerated.
The primary endpoint of the uveitis study was the difference from baseline in AC cell grades
between the Durezol and Pred Forte groups. At Day 14, the Durezol group achieved a mean cell
grade reduction of 2.1, compared to 1.9 in the Pred Forte group, confirming the noninferiority of
Durezol dosed QID to Pred Forte dosed eight times a day.
In addition to reducing mean cell grade, a greater percentage of patients receiving Durezol had
an AC cell grade of 0 (less than or equal to 1 cell) than did the Pred Forte group at Day 14 (69%
vs. 62%, respectively). This trend continued through Day 42.
Pain/ocular discomfort was assessed using a Visual Analog Scale. Durezol demonstrated a
numerical advantage in pain reduction from baseline over Pred Forte at every time point in the
study. As early as Day 3, the Durezol group had a reduction in mean pain score of 58% vs. 51%
in the Pred Forte group. At Day 7, these were 71% and 64%, respectively.
Two patients in each treatment arm experienced criterion increases in intraocular pressure
(defined as a pressure of ≥ 21 mmHg and a change from baseline ≥ 10mmHg at the same visit).
Another important safety finding was the number of patients withdrawn from the study due to lack
of efficacy. In the Pred Forte group, 12.5% of patients were withdrawn from the study, while no
Durezol patients were withdrawn from the study for these reasons. This difference was
significant, P=0.01.
Uveitis is responsible for an estimated 30,000 new cases of legal blindness each year in the US
and up to 15% of all cases of blindness. The most common form of the condition is anterior
uveitis, associated primarily with inflammation of the iris. If left untreated, uveitis can cause
debilitating pain and photophobia as well as permanent damage and vision loss due to the
development of glaucoma, cataract or retinal edema.
Dr. Kaufman’s poster, “Data from Trials Evaluating Ganciclovir Ophthalmic Gel, 0.15% and
Acyclovir Ophthalmic Ointment, 3% for Herpetic Keratitis,” is part of AAO Poster Session 1
(Sunday, November 09, 11:00 AM - 12:30 PM) on Level 1, Hall B-5. Dr. Kaufman’s review of data
from three Phase 2 trials and one Phase 3 trial of ganciclovir and acyclovir for herpetic keratitis
confirms the efficacy of ganciclovir for treatment of acute herpetic keratitis, as well as better
tolerance when compared to acyclovir and low incidence of adverse events.
The efficacy and safety data is from an extensive clinical program conducted outside of the US by
Laboratoires Théa of France, with which Sirion Therapeutics has an exclusive licensing
agreement for the US rights to develop and market ganciclovir ophthalmic gel, available in
Europe for the treatment of ocular viral infections for more than 10 years.
Herpes simplex keratitis is the leading cause of corneal blindness in the US, with 20,000 new
primary cases of diagnosed each year and an additional 28,000 cases of recurrence each year.
The risk of blindness increases with the number and severity of recurrences, so prompt treatment
of herpetic epithelial ulcers is imperative to limit scarring and other more serious complications.
About Durezol
Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmic corticosteroid
approved for the treatment of inflammation and pain associated with ocular surgery.
Difluprednate, the active ingredient in Durezol, is a difluorinated prednisolone derivative that has
potent anti-inflammatory activity. Durezol is not approved for the treatment of uveitis.
Important Safety Information
Like other corticosteroids, Durezol is contraindicated in patients with viral diseases of the cornea
and conjunctiva, and those with fungal or mycobacterial infections of the eye or ocular structures.
Prolonged use of corticosteroids may increase the hazard of secondary ocular bacterial
infections, exacerbate the severity of ocular viral infections, and increase the development of
fungal infections of the cornea. It is important to monitor intraocular pressure when using
ophthalmic steroids. The use of steroids after cataract surgery may delay healing and increase
the incidence of bleb formation.
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure,
which may be associated with optic nerve damage, visual acuity and field defects, posterior
subcapsular cataract formation, secondary ocular infection from pathogens including herpes
simplex, and perforation of the globe where there is thinning of the cornea or sclera.
Ocular adverse reactions occurring in 5–15% of subjects in clinical studies with Durezol included
corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule
opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
Other ocular adverse reactions occurring in 1–5% of patients included reduced visual acuity,
punctate keratitis, eye inflammation, and iritis. Ocular adverse events occurring in < 1% of
patients included application site discomfort or irritation, corneal pigmentation and striae,
episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased
lacrimation, macular edema, scleral hyperemia, and uveitis. Most of these events may have been
the consequence of the surgical procedure.
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 diverse product portfolio includes products that
address ocular diseases and conditions including uveitis, herpetic keratitis, dry eye, and
geographic atrophy associated with dry AMD. For more information, please visit
http://www.siriontherapeutics.com.
* Pred Forte is the registered trademark of Allergan, Inc.
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