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Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)

TAMPA, Fla., Oct. 14 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today preliminary results from a pivotal anterior uveitis trial that compared Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% dosed four times daily (QID) to Pred Forte(R) (prednisolone acetate ophthalmic suspension) 1%, dosed eight times daily. Durezol is a topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery; it was approved by the US Food and Drug Administration in June 2008. Pred Forte(R) is the registered trademark of Allergan, Inc.

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Ninety patients with endogenous anterior uveitis were studied in a multicenter, randomized, double-masked trial that compared the efficacy and safety of Durezol QID with Pred Forte eight times a day. Treatment for both study groups was administered for 14 days, with 2 weeks of tapering at half the dose and 2 weeks of follow-up (for a total 42 days) after initiation of therapy.

The primary endpoint was the difference from baseline in anterior chamber (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.

"This study shows that Durezol is a potent steroid that can be used effectively four times a day to reduce inflammation in patients with moderate to severe uveitis," explained C. Stephen Foster, MD, an investigator in the trial and the founder and president of the Massachusetts Eye Research and Surgery Institution. "This is especially important since the US standard of care currently necessitates dosing steroids every hour -- and as frequently as every 15-30 minutes in more severe cases. In addition, Durezol does not contain benzalkonium chloride (BAK), a common ocular preservative known to cause corneal toxicity with long-term use. This is especially important for patients with uveitis, which is a chronic disease. A strong steroid like Durezol will be a very valuable tool for ophthalmologists everywhere, allow patients to have an easier dosing regimen, and will most likely become the new standard of care for treating uveitis."

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.

Ocular discomfort and pain is a debilitating symptom of uveitis. In this study, pain 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.

Durezol was also very effective in reducing the symptoms of anterior ocular inflammation (pain/ocular discomfort, photophobia, blurred vision, and lacrimation). The Durezol group achieved a mean reduction in total symptom score of 76% vs 71% for Pred Forte at Day 14. This numerical difference was maintained through Day 42 with the Durezol group reducing the total symptom score by 86% vs 76% for the Pred Forte group.

The total sign score was also reduced to a greater degree in the Durezol group when compared to the Pred Forte group: 6.5 vs 6.1 at Day 14, respectively. Total sign score included the sums of posterior synechiae, hypopyon, limbal injection, peripheral anterior synechiae, AC flare, AC cell and keratic precipitate grades. The numerical advantage of Durezol over Pred Forte in total sign score continued throughout the study period.

Two patients in each treatment arm experienced criterion increases in intraocular pressure (defined as a pressure of greater than or equal to 21 mmHg and a change from baseline greater than or equal to 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.

The results from this study will be combined with data from previous trials conducted in Japan to support a supplemental New Drug Application for anterior uveitis. "The results of these trials are truly exciting," noted Barry Butler, CEO and President of Sirion Therapeutics. "Although this study was not designed to detect the statistical superiority of one drug over the other, the consistent numerical advantage of Durezol across all endpoints is impressive. This is especially so, when you consider that Pred Forte has 20 times the concentration of Durezol and was dosed twice as often. This clearly demonstrates the potency of Durezol."

About Uveitis

Uveitis is inflammation of the middle three layers of the eye: iris, choroid, and ciliary body. In the US it is responsible for an estimated 30,000 new cases of legal blindness each year and up to 15% of all cases of blindness. It affects 0.2% of the population in industrial nations, with as much as 10 times that prevalence in the undeveloped world. The most common form of the condition is anterior uveitis, associated primarily with inflammation of the iris. If left untreated, uveitis can cause permanent damage and vision loss due to the development of glaucoma, cataract, or retinal edema. In addition to causing blindness, the severe pain and photophobia that accompany anterior uveitis can be debilitating.

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. Prior to US approval, the efficacy and safety of difluprednate dosed four times a day in ocular inflammatory diseases had been demonstrated in an extensive preclinical and clinical program in Japan, including two studies in anterior uveitis and one in refractory uveitis. In two US Phase 3 trials evaluating Durezol in patients diagnosed with significant postoperative inflammation (more than 10 anterior chamber cells), Durezol effectively reduced inflammation and pain.

Dosage and Administration

The recommended dosage and administration of Durezol in the treatment of postoperative inflammation and pain is to instill one drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week with tapering based on the response.

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

SOURCE Sirion Therapeutics, Inc.
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