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Valeant's Glaucoma Drug Accepted for Review by the FDA

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Valeant Pharmaceuticals International, Inc. 's VRX subsidiary, Bausch + Lomb, and Nicox S.A. announced that the FDA has accepted the new drug application for investigational once-daily intraocular pressure (IOP) lowering single-agent eye drop, Vesneo (latanoprostene bunod ophthalmic solution 0.024%). Valeant is looking to get the candidate approved for the treatment of patients suffering from open-angle glaucoma or ocular hypertension.

A response from the FDA is expected by Jul 21, 2016.

Vesneo, a nitric oxide donating prostaglandin receptor agonist, was licensed by Nicox to Bausch + Lomb. Valeant holds the exclusive global rights to develop and commercialize products containing latanoprostene bunod for select indications.

Valeant believes that there is significant unmet need for treatments of open-angle glaucoma and ocular hypertension. If Vesneo is approved in the U.S., it will become the first nitric oxide donating prostaglandin receptor agonist for this indication. Nicox had stated along with its first-half 2015 results that as per a previous estimate by Valeant, upon approval of Vesneo, peak sales are expected to exceed $500 million in the U.S. and $1 billion globally. Once the product is launched, Valeant may have to pay milestones (up to $132.5 million net upon the achievement of commercial sales targets) and royalties (potential net tiered royalties on sales ranging between 6% - 11%) to Nicox.

Currently, Akorn, Inc.'s AKRX Zioptan 0.0015% is approved for reducing elevated IOP in patients suffering from open-angle glaucoma or ocular hypertension.

Valeant carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Corcept Therapeutics Incorporated CORT and AcelRx Pharmaceuticals, Inc. ACRX . While Corcept has a Zacks Rank #1 (Strong Buy), AcelRx carries a Zacks Rank #2 (Buy).

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VALEANT PHARMA (VRX): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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