FDA accepts NDA for review Vesneo (latanoprostene bunod ophthalmic solution) for treatment of glaucoma or ocular hypertension- Bausch + Lomb and Nicox SA
Valeant Pharmaceuticals International, Bausch + Lomb and Nicox S.A. announced that the FDA has accepted for review its New Drug Application (NDA) for Vesneo (latanoprostene bunod ophthalmic solution 0.024%), an intraocular pressure (IOP) 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 signalling. Vesneo was licensed by Nicox to Bausch + Lomb.
Comment: Nicox SA has exercised its option to co-market the drug in the USA.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins