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.
Lynbrook, NY—Ketotifen fumarate ophthalmic solution 0.025% (Zaditor, Novartis) offers potent, fast-acting treatment for the signs and symptoms of ocular allergy with excellent safety and the convenience of availability as an over-the-counter (OTC) medication, said Marguerite B. McDonald, MD.
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.
Irvine, CA—Visiogen Inc. has received FDA approval to expand the phase III clinical trial of its dual-optic accommodating IOL (Synchrony) in the United States.
San Diego—TargeGen has begun a phase I trial of a topical drug to treat age-related macular degeneration (AMD).
Irvine, CA—ISTA Pharmaceuticals Inc. has submitted an investigational new drug application with the FDA for its eye-drop formulation of bepotastine to treat allergic conjunctivitis.
Rochester, NY—Bausch & Lomb has purchased the over-the-counter (OTC) allergy franchise of Alimera Sciences Inc., a privately held company based in Atlanta.
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).