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Bausch + Lomb Gets FDA Approval for Glaucoma Drug

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It was licensed from Nicox.

Bausch + Lomb and Nicox S.A., an international ophthalmic company, announced that the U.S. Food and Drug Administration has approved the New Drug Application for Vyzulta.

Vyzulta is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The drug (latanoprostene bunod ophthalmic solution, 0.024 percent) is described in a press release as being the first prostaglandin analog with one of its metabolites being nitric oxide.

“With today’s approval of VYZULTA, our customers and their patients with glaucoma now have a new treatment option that can help provide consistent and sustained IOP lowering, the only modifiable risk factor that can help slow down the progression of the disease,” said Joseph C. Papa, chairman and CEO of Valeant Pharmaceuticals International, parent company of Bausch + Lomb. “We expect to make this new advancement available for those who suffer with glaucoma before the end of the year.”

Lowering intraocular pressure, even in patients with normal baseline levels, can delay, or even prevent damage to optic nerves, helping to reduce the risk of glaucomatous visual field loss, the release explains.

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Vyzulta was licensed on a global basis to Bausch + Lomb from Nicox. As a result of this approval, Nicox will receive $17.5 million from Bausch + Lomb and will make a $15 million payment to Pfizer under a previous license agreement.

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