The FDA has approved the new drug application for the once-daily glaucoma treatment Vyzulta, according to a press release issued jointly by Bausch + Lomb, a subsidiary of Valeant Pharmaceuticals, and Nicox S.A.
Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%) is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. It is the first prostaglandin analog to have nitric oxide as one of its metabolites, according to the release.
Following topical administration, the drug metabolizes into two moieties, latanoprost acid and butanediol mononitrate. The latanoprost acid works within the uveoscleral pathway to increase aqueous humor outflow, and the butanediol mononitrate releases nitric oxide to increase outflow through the trabecular meshwork and Schlemm’s canal, according to the release.
“Vyzulta represents the first FDA-approved therapy developed through our proprietary nitric oxide-donating research platform,” Michele Garufi, chairman and CEO of Nicox, said in the release. “We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds.”
The most common ocular adverse events include conjunctival hyperemia, eye irritation, eye pain and instillation site pain, according to the release.
Based on this approval, Nicox will receive $17.5 million from Bausch + Lomb and will make a $15 million payment to Pfizer under a previous license agreement. Vyzulta was licensed on a global basis to Bausch + Lomb from Nicox, according to the release.