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Alcon to purchase rights for two eye care products from Sirion Therapeutics
Switzerland | Wednesday, January 20, 2010, 08:00 Hrs  [IST]

Alcon, the world's leader in eye care, announced that it will purchase the rights in the United States for two FDA-approved topical eye care products from Sirion Therapeutics, Inc.

The two products purchased are Durezol, a marketed ophthalmic corticosteroid approved for the treatment of inflammation and pain associated with eye surgery, and Zirgan, a recently approved antiviral for the treatment of acute herpetic keratitis (corneal ulcers). In addition to these marketed products, Alcon also acquired the global rights, excluding Latin America, for Zyclorin. This product is currently in clinical development to treat dry eye and other ocular surface diseases.

"The acquisition of these products from Sirion is part of our business development strategy to gain access to late-stage or approved products that will incrementally add to sales in the near-term, while also building our long-term pipeline," said Kevin Buehler, Alcon's president and chief executive officer. "Upon closing, this deal will allow Alcon to capitalize on the US registration approval for Durezol and Zirgan with the existing commercial capability in the United States to maximize the brand development and revenue opportunities."

"Durezol provides physicians with a steroid to treat both inflammation and pain following a wide range of ophthalmic surgeries," said Robert H. Osher, MD, professor of ophthalmology at the University of Cincinnati College of Medicine and medical director emeritus of the Cincinnati Eye Institute. "Physicians will also appreciate the comfort and relief our patients receive for herpetic corneal ulcers with Zirgan, due to its low toxicity, potency and targeted antiviral effect."

The closing of this agreement is expected to occur by the end of the first quarter of 2010 and is contingent upon customary closing conditions and required regulatory approvals.

Cataracts and glaucoma affect more than 24 million people age 40 and older in the United States. Many of these people seek surgical treatment for these and other eye conditions. Corticosteroids and non-steroidal anti-inflammatory drugs are commonly used after eye surgery to manage postoperative pain and inflammation. Complications can occur if inflammation is left untreated and can interfere with a patient's visual rehabilitation.

Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmic corticosteroid for the treatment of postoperative inflammation and pain associated with ocular surgery. Durezol received approval from the US Food and Drug Administration (FDA) in 2008 and was the first ophthalmic steroid to be approved for both postoperative inflammation and pain. Clinical trials demonstrated that Durezol reduced ocular pain and inflammation rapidly and effectively for patients following ocular surgery.

Durezol is a difluorinated derivative of prednisolone and has anti-inflammatory activity. The recommended dosing regimen for Durezol is one drop four times daily beginning 24 hours after surgery and continuing throughout the first two weeks of the postoperative period, followed by two times daily for a week and then tapering off thereafter based on the response.

The most common 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.

Zirgan (ganciclovir ophthalmic gel) 0.15% is indicated for topical ophthalmic use as a treatment for acute herpetic keratitis (dendritic corneal ulcers). Zirgan is an innovative topical antiviral therapy designed to specifically target viral-infected cells and has a low corneal toxicity profile, providing patients comfort and relief. Zirgan has been a leading treatment for corneal ulcers, under the brand name Virgan, in Europe for more than 10 years. The FDA also has designated Zirgan as an orphan drug, which is a special status for rare diseases or conditions that affect fewer than 200,000 patients in the US.

The recommended dosing for Zirgan is one drop five times per day until the ulcer heals, and then one drop three times per day for seven days. The most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%). Alcon anticipates Zirgan to become available in the US by prescription in 2010.

Zyclorin (cyclosporine) is a topical ophthalmic immunomodulator and immunosuppressive agent. Zyclorin is an investigational drug and is not approved by the US Food and Drug Administration. It is being studied for the treatment of ocular surface diseases, including dry eye, which affects millions of Americans.

Alcon, Inc. is the world's leading eye care company, with sales of approximately $6.3 billion in 2008. Alcon, which has been dedicated to the ophthalmic industry for 65 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contacts lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye.

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