Pharmacy

ISTA Pharmaceuticals plans sNDA for once-daily bromfenac

March 7, 2007

Irvine, CA—ISTA Pharmaceuticals Inc. plans to file a supplemental new drug application with the FDA later this year based on preliminary results and pending further analyses of a phase III trial of its once-daily formulation of bromfenac sodium ophthalmic solution (Xibrom). If approved, this formulation of the topical non-steroidal anti-inflammatory drug (NSAID) would become the only once-daily treatment for ocular pain and inflammation after cataract surgery.

Orphan status given to two drugs

February 15, 2007
Jersey City, NJ—The FDA has granted orphan drug designation to two investigational therapeutics of Lux Biosciences, a privately held biotechnical company specializing in treatments for ophthalmic diseases.

Sodium hyaluronate compound studied

February 15, 2007
Chapel Hill, NC—Lantibio Inc. and TRB Chemedica have begun a phase III clinical trial with VISMED, a patented formulation containing sodium hyaluronate, to treat dry eye syndrome.

Antihistamine acquired from Alimera Sciences

February 15, 2007

Rochester, NY—Bausch & Lomb has purchased Alimera Sciences' over-the-counter allergy franchise, including ketotifen fumarate ophthalmic solution 0.025% (Alaway), which was recently approved by the FDA.

Othera Pharmaceuticals, NEI begin dry AMD study

January 10, 2007

Exton, PA—Othera Pharmaceuticals Inc. has begun enrollment for a phase II clinical trial of its topical eye drop OT-551 in patients with bilateral geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD).

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