FDA accepts review application for new glaucoma drug Vesneo

The U.S. Food and Drug Administration (FDA) recently agreed to review a New Drug Application (NDA) for Vesneo, an intraocular pressure-lowering, single-agent eye drop used once daily.

Vesneo is a product of Valeant Pharmaceuticals International subsidiary Bausch + Lomb  and Nicox S.A.
Vesneo is indicated for use by patients with open-angle glaucoma or ocular hypertension. Should it be approved, Vesneo will become the first nitric oxide donating prostaglandin receptor agonist available for these conditions.

The goal of Vesneo use is to increase aqueous-humor outflow by acting on both the uveoscleral (non-conventional) pathway via latanoprost acid, and trabecular meshwork and Schlemm's canal (conventional pathway) via nitric oxide signaling.

Vesneo was licensed by Nicox to Bausch + Lomb.

"The acceptance for review of the Vesneo NDA by the FDA marks an important milestone in our effort to bring a new treatment to patients with open-angle glaucoma and ocular hypertension," J. Michael Pearson, chairman and CEO of Valeant, said. "It is also another illustration of how Valeant's robust pipeline continues to be filled by a commitment to innovation driven by significant R&D programs and partnerships focused on the needs of medical professionals and their patients around the world."

Michele Garufi, chairman and CEO of Nicox, agreed.

"If granted, the FDA's approval of Vesneo will clear the way for the first truly novel IOP-lowering medication in years," Garufi said. "Open-angle glaucoma and ocular hypertension represent significant unmet medical needs. The clinical advancement of Vesneo is particularly gratifying, as it validates the therapeutic and commercial potential of our proprietary nitric oxide-donating R&D platform, which we will continue to leverage in the development of additional innovative ophthalmic compounds."

The FDA's action date to complete its review on Vesneo is July 21, 2016.

More information about Valeant Pharmaceuticals International can be found online at www.valeant.com.

For more information on Nicox, its commercial products or pipeline, visit www.nicox.com.

Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops and markets prescription drugs.