Bausch + Lomb and Nicox announced that the FDA has approved Vyzulta (latanoprostene bunod ophthalmic solution 0.024%), indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. Vyzulta is the first prostaglandin analog with one of its metabolites being nitric oxide (NO).
“Vyzulta, like other prostaglandin analogs, is a once-daily monotherapy. However, unlike other prostaglandin analogs, it has a dual mechanism of action,” Robert N. Weinreb, MD, chairman and distinguished professor of ophthalmology and director, Hamilton Glaucoma Center at the University of California San Diego, said in an interview with Eyewiretoday.com. “It works by metabolizing two moieties – latanoprost acid and butanediol mononitrate – which each target a specific pathway.”
“Latanoprost acid is well known to ophthalmologists. It’s an F2-alpha prostaglandin analog, and primarily works within the uveoscleral pathway to increase aqueous humor outflow, so it’s increasing outflow through the nonconventional pathway. The second, butanediol mononitrate, releases nitric oxide, to increase outflow through the trabecular meshwork and Schlemm’s canal, and this clearly differentiates it from other prostaglandin analogs that are being used to treat glaucoma,” Dr. Weinreb added.
The most common ocular adverse events include conjunctival hyperemia, eye irritation, eye pain, and instillation site pain. Increased pigmentation of the iris and periorbital tissue and growth of eyelashes can occur.
“Vyzulta represents the first FDA-approved therapy developed through our proprietary NO-donating research platform,” Michele Garufi, chairman and CEO of Nicox, said in a company news release. “We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds.”
Preclinical studies have shown that NO plays a role in controlling IOP in normal eyes by increasing aqueous humor outflow through the trabecular meshwork and Schlemm’s canal. Studies have also demonstrated that patients with glaucoma have reduced levels of NO signaling in their eyes, providing a rationale for the therapeutic value of NO-releasing molecules for patients with open-angle glaucoma or ocular hypertension.
Vyzulta was licensed on a global basis to Bausch + Lomb from Nicox. As a result of 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.