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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.

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Potent, safe allergic conjunctivitis treatment available OTC

February 15, 2007
  • Cheryl Guttman

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.

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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.
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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.
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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.

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FDA approves trial expansion for dual-optic accommodating IOL

February 7, 2007

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.

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Clinical trial under way for topical AMD therapy

January 15, 2007

San Diego—TargeGen has begun a phase I trial of a topical drug to treat age-related macular degeneration (AMD).

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ISTA Pharmaceuticals files IND application for drop to treat allergic conjunctivitis

January 10, 2007

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.

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Bausch & Lomb acquires OTC allergy franchise of Alimera Sciences

January 10, 2007

Rochester, NY—Bausch & Lomb has purchased the over-the-counter (OTC) allergy franchise of Alimera Sciences Inc., a privately held company based in Atlanta.

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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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