Bausch + Lomb Receives US FDA Approval for Vyzulta for IOP Reduction in Glaucoma Patients

November 3, 2017: By Jon Swedien

Bausch

The US FDA has approved the new drug application (NDA) for Bausch + Lomb’s Vyzulta for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, parent Valeant announced Nov. 2.

Vyzulta (latanoprostene bunod ophthalmic solution 0.024%), a nitric oxide-donating prostaglandin analog, is a once daily monotherapy.

Valeant CEO Joseph Papa said the company plans to launch Vyzulta by the end of 2017.

Nicox licensed Vyzulta to Bausch + Lomb on a global basis in 2010. As a result of the approval, Nicox will receive $17.5 million from Bausch + Lomb, and Nicox will make a $15 million payment to Pfizer under a previous license agreement, Valeant said.

Vyzulta’s approval was delayed twice because of problems at Bausch + Lomb’s manufacturing plant in Tampa, Florida. The FDA held up several ophthalmic drug candidates over plant concerns in 2016 and 2017.

Valeant resolved its issues, allowing the regulatory process to proceed.

In multiple clinical studies, Vyzulta outperformed timolol and latanoprost in lowering IOP, the company said.

Previously known as Vesneo, the drug was renamed Vyzulta in January.

The most common ocular adverse events associated with Vyzulta include conjunctival hyperemia, eye irritation, eye pain, and instillation site pain, Valeant said. Increased pigmentation of the iris and periorbital tissue and growth of eyelashes also can occur, Valeant said.

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