FDA Approves Vyzulta to Relieve Intraocular Pressure

The FDA has approved Vyzulta 0.024% (latanoprostene bunod ophthalmic solution) as treatment to reduce intraocular pressure (IOP) for patients with open-angle glaucoma or ocular hypertension. Vyzulta is the first prostaglandin analog with a nitric oxide (NO) metabolite to gain approval from the FDA.

"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," Robert N. Weinreb, MD, chairman and distinguished professor of Ophthalmology and director, Hamilton Glaucoma Center at the University of California San Diego, said in a statement. "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."

Vyzulta exchanged hands several times before gaining approval. It was developed by Nicox and out-licensed to Bausch + Lomb, which was bought by Valeant. The approval triggered a $17.5 million payment to Nicox. Additionally, under a previous license agreement, Pfizer will receive a $15 million payment.

Vyzulta was explored in the phase 3 APOLLO and LUNAR clinical trials, in which the 0.024% solution was shown to be non-inferior and superior to timolol 0.5% (32% Mean Diurnal IOP Reduction) in 831 patients with open-angle glaucoma or ocular hypertension. In the studies, Vyzulta was given once daily and timolol was given twice daily.

In both studies, IOP reduction over 3 months was non-inferior between the two treatment groups. Moreover, Vyzulta was found to be superior for daytime IOP reduction, with a mean reduction in diurnal IOP of 32%. The most common adverse events with Vyzulta in the study were conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%).

These findings were added to phase 2 results that compared Vyzulta with Latanopost in 413 patients. In this study, Vyzulta showed a 1.23 mm reduction in IOP compared with Xalatan (latanoprost ophthalmic solution, 0.005%). In addition, of those treated with the 0.024% Vyzulta solution, 68.7% achieved a mean diurnal IOP of ≤18 mm Hg compared with 47.5% of those treated with Xalatan.

"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," Joseph C. Papa, chairman and CEO, Valeant, said in a statement. "We expect to make this new advancement available for those who suffer with glaucoma before the end of the year."

A smaller study (n = 25) looking at Vyzulta also demonstrated quick IOP reductions with the NO-metabolite solution, when compared with timolol. Overall, there were greater declines in IOP over 24 hours and significantly greater nocturnal IOP reduction with Vyzulta versus timolol (P <.004).

"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 statement. "We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds."