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FDA sets action date for OTC brimonidine drop

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The FDA has accepted the New Drug Application for brimonidine tartrate ophthalmic solution and set a PDUFA action date for Dec. 27, according to a press release from Valeant Pharmaceuticals and Bausch + Lomb.

Luminesse (brimonidine tartrate, Bausch + Lomb) is an over-the-counter eye (OTC) drop designed to relieve redness of the eye due to minor irritations. If approved, this would be the first OTC treatment with brimonidine tartrate, the company said.

Six studies assessed the safety and efficacy of Luminesse, and all had positive outcomes.

“The filing acceptance of Luminesse brings us one step closer to bringing a new treatment option to potentially help patients in the more than 14 million households who use OTC eye drops to treat ocular redness,” Joseph C. Papa, chairman and CEO of Valeant, said in the release. “If approved, Luminesse may provide patients with ocular redness significant benefits vs. other competing redness reliever products currently available.”