Bausch & Lomb and Nicox's Glaucoma Treatment Succeeds In Phase 3 Clinical Trial

Latanoprostene bunod, brand name Vesneo, a collaboration between Valeant subsidiary Bausch & Lomb and Nicox, has hit its primary endpoint in phase 3 clinical trials and its New Drug Application could hit the FDA’s desk by mid-2015.

Glaucoma is a series of eye diseases which cause an excess of intraocular pressure (IOP) leading to optic nerve damage and, if untreated, blindness. Open angle glaucoma  is the most common form  and comprises 90 percent of glaucoma cases. Clogs in the eyes’ drainage canals lead to an increase in IOP.

Vesneo is a nitric oxide-donating prostaglandin F2-alpha analog. Researchers found that Vesneo used once a day showed a comparable reduction in IOP when tested against timolol maleate, the active ingredient in Merck’s twice-daily Timoptic.  The study found that Vesneo reached its primary endpoint (reduction of mean IOP) as well as several secondary endpoints in the treatment of open angle glaucoma and ocular hypertension.

Robert Weinreb, chairman of the Hamilton Glaucoma Center at the University of California San Diego confirmed the success. He reported, “The results of these studies confirm the results observed in the phase 2b trials. Vesneo effectively lowered IOP, which is critical in the management of glaucoma or ocular hypertension, and was well tolerated.”

According to Michele Garufi, CEO of Nicox, “Vesneo was discovered in our research laboratories in Milan and we are encouraged by these promising results from Bausch & Lomb’s pivotal Phase 3 studies. The success of this program thus far highlights the promise of nitric oxide donation in the treatment of serious ophthalmic conditions.”

Currently, there is no cure for glaucoma, and vision, once lost, cannot be regained. The Glaucoma Foundation estimates that over 2.2 million Americans suffer from glaucoma, but half are unaware. Early detection and treatment are key to the management of the disease and its progression.

Valeant forecasts $500M dollars of business for Vesneo in the U.S. alone, with a potential for a billion dollar market globally.  If approved, Vesneo will join Valeant’s recent releases of cream and gel products, which have recently won approvals from the FDA. These treatments include Luzu and Jublia, topical anti-fungal treatments, and Retin-A Micro, a topical treatment for acne.