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FDA Accepts New Drug Application for Vesneo
The FDA has accepted for review a new drug application for latanoprostene bunod ophthalmic solution 0.024% (Vesneo, Bausch & Lomb/Nicox), a single-agent eye drop dosed once daily to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. If approved, Vesneo would be the first nitric oxide donating prostaglandin receptor agonist available for this 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 that plays a key role in IOP regulation in healthy eyes. Vesneo is thought to increase aqueous humor outflow by acting on both the uveoscleral (nonconventional) pathway via latanoprost acid and the trabecular meshwork and Schlemm’s canal (conventional) pathway via nitric oxide signaling.
Vesneo was licensed by Nicox to Bausch & Lomb. The FDA has set an action date of July 21, 2016, to complete its review under the Prescription Drug User Fee Act (PDUFA).
Source: Bausch & Lomb; September 22, 2015.