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.

InSite Vision Incorporated has announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb’s besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision’s DuraSite® patented drug delivery system. DuraSite is a synthetic polymer of cross-linked polyacrylic acid that stabilizes small molecules in an aqueous matrix, allowing for targeted and sustained administration. DuraSite enables a less frequent dosing schedule, increased patient compliance, and increased efficacy.

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.

Regenerx Biopharmaceuticals, Inc. has announced that its ophthalmic drug candidate, RGN-259, was used to treat four neurotrophic keratitis patients with non-healing eye ulcers caused primarily by the herpes zoster virus under a “Compassionate Use” IND (Investigational New Drug application). RGN-259 is a sterile eye drop formulation of Tβ4 being developed by RegeneRx for use in treating ophthalmic wounds and related disorders. In all four patients, the eye ulcers either completely healed or demonstrated significant improvement by treatment day 28, the maximum treatment period allowed under the clinical protocol.

The U.S. Food and Drug Administration has given the final approval to Hi-Tech Pharmacal Company’s dorzolamide and timolol ophthalmic solution, the generic for Merck’s Cosopt®. Indicated for lessening elevated intraocular pressure in patients suffering from ocular hypertension or open-angle glaucoma, the generic solution will be launched in the markets soon. Hi-Tech Pharmacal Co. Inc. specializes in manufacturing semi-solid and liquid dosage forms of sterile ophthalmic and inhalation products.

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.