New treatment option for glaucoma approved by FDA

A new drug application (NDA) for VYZULTA — a prostaglandin analogue indicated for the reduction of intraocular pressure (IOP) — has been approved by the US Food and Drug Administration (FDA).

VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is a prostaglandin analogue, with one of its metabolites being nitric oxide (NO), indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. The drug was developed by Nicox — an international ophthalmic company — and licensed on a global basis to Bausch + Lomb — a global eye health company that is a wholly owned subsidiary of Valeant Pharmaceuticals.

“With today's approval of VYZULTA, our customers and their patients with glaucoma now have a new treatment option that can help provide consistent and sustained IOP lowering, the only modifiable risk factor that can help slow down the progression of the disease,” said Joseph C. Papa, chairman and CEO, Valeant. “We expect to make this new advancement available for those who suffer with glaucoma before the end of the year.”

“VYZULTA represents the first FDA-approved therapy developed through our proprietary NO-donating research platform,” added Michele Garufi, chairman and CEO of Nicox. “We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds.”

“The safety and efficacy of VYZULTA has been well-established through multiple clinical studies, which have demonstrated positive results, including statistically significant differences in IOP lowering compared to timolol and latanoprost,” explained Dr Robert N. Weinreb, chairman and distinguished professor of Ophthalmology and director, Hamilton Glaucoma Center at the University of California San Diego. “As one molecule with a dual mechanism of action, VYZULTA provides a new treatment option that works to reduce IOP by increasing the outflow through both the trabecular meshwork and the uveoscleral pathways.”

The treatment is administered topically, once a day and works by metabolising into two moieties, latanoprost acid, which primarily works within the uveoscleral pathway to increase aqueous humour outflow, and butanediol mononitrate, which releases NO to increase outflow through the trabecular meshwork and Schlemm's canal.

According to a release from Valeant, preclinical studies have shown that NO plays a role in controlling IOP in normal eyes by increasing aqueous humour outflow through the trabecular meshwork and Schlemm's canal. Studies have also demonstrated that patients with glaucoma have reduced levels of NO signalling in their eyes, providing a rationale for the therapeutic value of NO-releasing molecules for patients with open-angle glaucoma or ocular hypertension.