Durezol(TM) in the Treatment of Uveitis and Ganciclovir in the Treatment of Herpetic Keratitis: Studies of Treatments for Leading Causes of Blindness to Be Presented

Tuesday, November 4, 2008 General News
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TAMPA, Fla., Nov. 3 Sirion Therapeutics, Inc., a privatelyheld ophthalmic-focused biopharmaceutical company, announced today thatstudies of two investigational drugs in development for treatment ofpotentially blinding eye diseases will be presented at upcoming ophthalmologymeetings: At the American Uveitis Society's annual invitational meeting(November 9, Atlanta Marriott Marquis, Atlanta), preliminary results will bepresented from an anterior uveitis trial that compared Sirion's ophthalmiccorticosteroid Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% dosedfour times daily (QID) to Pred Forte(R)* (prednisolone acetate ophthalmicsuspension) 1%, dosed eight times daily. Durezol was approved by the US Foodand Drug Administration in June 2008 for the treatment of inflammation andpain associated with ocular surgery.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080220/CLW064LOGO )

In addition, data for Sirion's ophthalmic gel formulation of gancicloviras a treatment for herpetic keratitis will be presented in a poster at theAmerican Academy of Ophthalmology (AAO) Meeting (November 8-11, Atlanta). Theposter's author is Herbert E. Kaufman, M.D., Ophthalmologist Emeritus ofSirion Therapeutics and formerly Professor of Ophthalmology and Pharmacologyand Head of the Department of Ophthalmology at LSU Medical Center, and pastpresident of the Association for Research and Vision in Ophthalmology (ARVO),the International Society of Refractive Surgery (ISRS) and the Contact LensAssociation of Ophthalmologists (CLAO).

"We're proud to have products in late-stage clinical testing for two ofthe leading causes of blindness, uveitis and ocular herpes," said BarryButler, President and CEO of Sirion Therapeutics, Inc. "These medications havethe potential to reduce suffering and save the vision of thousands of patienteach year, and exemplify our mission to address unmet medical needs in theprotection and preservation of eyesight."

The results of the Durezol uveitis study will be presented by investigatorThomas Flynn, M.D., Assistant Professor of Clinical Ophthalmology, ColumbiaUniversity, and Ellsworth Uveitis & Retina Care, in his presentation, "DurezolCompared to Pred Forte in the Treatment of Endogenous Anterior Uveitis." Therandomized, multicenter, double-masked trial included 90 subjects withendogenous anterior uveitis having greater than 10 cells and a flare score ofgreater than or equal to 2 in the anterior chamber (AC). In the study, Durezoladministered QID was as effective as Pred Forte dosed eight times a day intreating uveitis. Durezol was also safe and well tolerated.

The primary endpoint of the uveitis study was the difference from baselinein AC cell grades between the Durezol and Pred Forte groups. At Day 14, theDurezol group achieved a mean cell grade reduction of 2.1, compared to 1.9 inthe Pred Forte group, confirming the noninferiority of Durezol dosed QID toPred Forte dosed eight times a day.

In addition to reducing mean cell grade, a greater percentage of patientsreceiving 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). Thistrend continued through Day 42.

Pain/ocular discomfort was assessed using a Visual Analog Scale. Durezoldemonstrated a numerical advantage in pain reduction from baseline over PredForte at every time point in the study. As early as Day 3, the Durezol grouphad a reduction in mean pain score of 58% vs. 51% in the Pred Forte group. AtDay 7, these were 71% and 64%, respectively.

Two patients in each treatment arm experienced criterion increases inintraocular pressure (defined as a pressure of greater than or equal to 21mmHg and a change from baseline greater than or equal to 10mmHg at the samevisit). Another important safety finding was the number of patients withdrawnfrom the study due to lack of efficacy. In the Pred Forte group, 12.5% ofpatients were withdrawn from the study, while no Durezol patients werewithdrawn from the study for these reasons. This difference was significant,P=0.01.

Uveitis is responsible for an estimated 30,000 new cases of legalblindness each year in the US and up to 15% of all cases of blindness. Themost common form of the condition is anterior uveitis, associated primarilywith inflammation of the iris. If left untreated, uveitis can causedebilitating pain and photophobia as well as permanent damage and vision lossdue to the development of glaucoma, cataract or retinal edema.

Dr. Kaufman's poster, "Data from Trials Evaluating Ganciclovir OphthalmicGel, 0.15% and Acyclovir Ophthalmic Ointment, 3% for Herpetic Keratitis," ispart of AAO Poster Session 1 (Sunday, November 09, 11:00 AM - 12:30 PM) onLevel 1, Hall B-5. Dr. Kaufman's review of data from three Phase 2 trials andone Phase 3 trial of ganciclovir and acyclovir for herpetic keratitis confirmsthe efficacy of ganciclovir for treatment of acute herpetic keratitis, as wellas better tolerance when compared to acyclovir and low incidence of adverseevents.

The efficacy and safety data is from an extensive clinical programconducted outside of the US by Laboratoires Thea of France, with which SirionTherapeutics has an exclusive licensing agreement for the US rights to developand market ganciclovir ophthalmic gel, available in Europe for the treatmentof ocular viral infections for more than 10 years.

Herpes simplex keratitis is the leading cause of corneal blindness in theUS, with 20,000 new primary cases of diagnosed each year and an additional28,000 cases of recurrence each year. The risk of blindness increases with thenumber and severity of recurrences, so prompt treatment of herpetic epithelialulcers is imperative to limit scarring and other more serious complications.

About Durezol

Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmiccorticosteroid approved for the treatment of inflammation and pain associatedwith ocular surgery. Difluprednate, the active ingredient in Durezol, is adifluorinated prednisolone derivative that has potent anti-inflammatoryactivity. Durezol is not approved for the treatment of uveitis.

Important Safety Information

Like other corticosteroids, Durezol is contraindicated in patients withviral diseases of the cornea and conjunctiva, and those with fungal ormycobacterial infections of the eye or ocular structures. Prolonged use ofcorticosteroids may increase the hazard of secondary ocular bacterialinfections, exacerbate the severity of ocular viral infections, and increasethe development of fungal infections of the cornea. It is important to monitorintraocular pressure when using ophthalmic steroids. The use of steroids aftercataract surgery may delay healing and increase the incidence of blebformation.

Adverse reactions associated with ophthalmic steroids include elevatedintraocular pressure, which may be associated with optic nerve damage, visualacuity and field defects, posterior subcapsular cataract formation, secondaryocular infection from pathogens including herpes simplex, and perforation ofthe globe where there is thinning of the cornea or sclera.

Ocular adverse reactions occurring in 5-15% of subjects in clinicalstudies with Durezol included corneal edema, ciliary and conjunctivalhyperemia, eye pain, photophobia, posterior capsule opacification, anteriorchamber cells, anterior chamber flare, conjunctival edema, and blepharitis.Other ocular adverse reactions occurring in 1-5% of patients included reducedvisual acuity, punctate keratitis, eye inflammation, and iritis. Ocularadverse events occurring in less than 1% of patients included application sitediscomfort or irritation, corneal pigmentation and striae, episcleritis, eyepruritis, eyelid irritation and crusting, foreign body sensation, increasedlacrimation, macular edema, scleral hyperemia, and uveitis. Most of theseevents may have been the consequence of the surgical procedure.

About Sirion Therapeutics, Inc.

Sirion Therapeutics is a privately held biopharmaceutical company pursuingthe discovery, development, and commercialization of products addressing unmetmedical needs in the protection and preservation of eyesight. Sirion's diverseproduct portfolio includes products that address ocular diseases andconditions including uveitis, herpetic keratitis, dry eye, and geographicatrophy associated with dry AMD. For more information, please visithttp://www.siriontherapeutics.com.

* Pred Forte is the registered trademark of Allergan, Inc.

SOURCE Sirion Therapeutics, Inc.

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