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FDA sets Aug. 24 as PDUFA date for latanoprostene bunod

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The FDA has set Aug. 24 for its decision on the new drug application for latanoprostene bunod, according to a press release from Bausch + Lomb and Nicox.

Latanoprostene bunod ophthalmic solution 0.024% is a single-agent once-daily eye drop designed to lower IOP in patients with open-angle glaucoma or ocular hypertension. If approved, it will be the first nitric-oxide donating prostaglandin F2 alpha analog for ophthalmic use, the release said.

“This is an exciting development in our journey to bring this new treatment option to the more than 3 million patients in the U.S. with open-angle glaucoma and ocular hypertension, and address a significant unmet medical need,” Joseph C. Papa, chairman and CEO of Valeant, said in the release.

Bausch + Lomb previously licensed latanoprostene bunod from Nicox.