Alcon has bought rights for and Zirgan from Sirion Therapeutics Inc. for an undisclosed amount. While Durezol is an ophthalmic corticosteroid approved for the treatment of inflammation and pain associated with eye surgery, Zirgan is an antiviral for the treatment of corneal ulcers. Both products have been approved by the Food and Drug Administration.

Alcon said it has acquired the global rights, excluding Latin America, for Zyclorin, which is being developed as a potential treatment for dry eyes and other diseases.

The FDA has approved Ista Pharmaceuticals’ bepotastine besilate ophthalmic solution 1.5% as a twice-daily eye drop for treating ocular itching due to allergic conjunctivitis. Bepreve (bepotastine besilate ophthalmic solution 1.5%) is a non-sedating, highly selective histamine receptor antagonist that stabilizes mast cells and suppresses the migration of eosinophils through inflamed tissue.

The pharmaceutical company ISTA Pharmaceuticals won unanimous support from the FDA committee for the approval of Bepreve eye drops for the treatment of itchy eyes. The eye drops are designed to treat patients aged 2 years and more with itchy eyes due to allergies. The vote by the FDA was 7-0 as it believed that ISTA had proved the effectiveness and safety of Berpreve and the eye medication will be sold by prescription only.

ISTA Pharmaceuticals is planning to ask the FDA to approve a change to the label of its bromfenac 0.09% ophthalmic solution. It has obtaining positive preliminary phase III results in a confirmatory clinical study of once-daily bromfenac (Xibrom QD) for the treatment of inflammation and pain after cataract surgery. The topical non-steroidal anti-inflammatory compound currently is labeled for twice-daily use beginning 24 hours after such surgeries.

Bausch & Lomb has announced that its pink eye drug besifloxacin is currently is likely to get recommended by the FDA. Its Dermatologic and Ophthalmic Drugs Advisory Committee voted to recommend approval for besifloxacin 0.6. The drug is required for treatment of bacterial conjunctivitis. Bausch & Lomb plans to start marketing besifloxacin in the U.S. in 2009, pending FDA approval. It can be added that Conjunctivitis is an inflammation of the conjunctiva most commonly due to an allergic reaction or an infection.

Sirion Therapeutics, Inc. has released results of a comparative trial evaluating the efficacy of Durezol(TM) 0.05% dosed four times daily against Allergan’s Pred Forte(R) 1%, dosed eight times daily. A topical ophthalmic corticosteroid, Durezol was indicated by the FDA in June 2008 for treating pain and inflammation related to ocular surgery. At the end of two weeks, the Durezol group achieved a mean cell grade reduction of 2.1, compared to 1.9 in the Pred Forte group, showing the potential of Durezol as a steroid.

Akorn announced that it has received FDA approval for its Ofloxacin Ophthalmic Solution USP, 0.3%. Ofloxacin Ophthalmic Solution USP, 0.3%, is the generic version of Ophthalmic Solution to treat infections caused by bacteria in conjunctivitis and corneal ulcers. The branded drug had generated sales of approximately $7.5 million in 2007. Akorn plans to manufacture the generic drug in its Decatur, Illinois, facility, and expects to launch the drug in the third quarter of 2008.

Sirion Therapeutics Inc. has received FDA approval for its New Drug Application (NDA) for Durezol(TM). The FDA has granted the drug priority review, which means that the review would be completed in six months from the date of receipt of the NDA. The NDA is for Sirion Therapeutics’ investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.