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Generic OptiPranolol granted U.S. marketing approval

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FORT WORTH, Texas — The Food and Drug Administration on Aug. 6 approved Falcon Pharmaceuticals' ANDA application for Metipranolol Ophthalmic Solution, 0.3% for the treatment of open angle glaucoma. Falcon is marketing the beta-blocker in both 5-mL and 10-mL doses.

Metipranolol Ophthalmic Solution is Falcon's generic equivalent to Bausch & Lomb's OptiPranolol. More than 500,000 prescriptions for OptiPranolol have been written since 1996, according to Bausch & Lomb data. In clinical studies, OptiPranolol exhibited comparable efficacy to timolol maleate 0.5% ophthalmic solution, and may result in less impairment of exercise-induced tachycardia.

In controlled studies of patients with IOP of greater than 24 mm Hg at baseline, OptiPranolol reduced the average IOP by about 20% to 26%.

According to Falcon executives, the company immediately began marketing Metipranolol as soon as it received FDA approval. Falcon is an affiliate of Alcon Laboratories, also based here.