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Allergan receives approvable letter for combination glaucoma drug

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IRVINE, Calif. — The U.S. Food and Drug Administration issued an "approvable" letter to Allergan Inc. for its combination brimonidine/timolol glaucoma medication Combigan, the company announced in a press release.

Combigan is indicated for patients with glaucoma or ocular hypertension who have inadequately controlled IOP requiring adjunctive or replacement treatment.

In the letter, the FDA requested an additional study to address "certain questions" about the drug, which combines brimonidine tartrate 0.2% and timolol maleate 0.5%, the press release said. According to Scott M. Whitcup, Allergan's executive vice president for research and development, "Allergan already commenced a clinical study at the end of 2005 that addresses the remaining FDA questions."

Combigan is approved and marketed in Europe, Canada, Brazil and Australia, according to the release.