(Press Release) Valeant Pharmaceuticals International’s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. have announced that the U.S. Food and Drug Administration has accepted for review its New Drug Application for VESNEO (latanoprostene bunod ophthalmic solution 0.024%), an intraocular pressure-lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension.
If approved, VESNEO will be the first nitric oxide donating prostaglandin receptor agonist available for the above indication.
Upon instillation in the eye, latanoprostene bunod is rapidly metabolized to two actives; latanoprost acid, a prostaglandin analog, and nitric oxide. Nitric oxide is an important physiological signaling molecule, which plays a key role in IOP regulation in healthy eyes. VESNEO is thought 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,” stated J. Michael Pearson, chairman and chief executive officer of Valeant. “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.”
“If granted, the FDA’s approval of VESNEO will clear the way for the first truly novel IOP-lowering medication in years,” said Michele Garufi, chairman and CEO of Nicox. “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 has set an action date of July 21, 2016 to complete its review, as per the Prescription Drug User Fee Act (PDUFA).