NOV 03, 2017
The FDA has approved latanoprostene bunod (Vyzulta), a nitric oxide (NO)-donating prostaglandin analog, for reducing IOP in patients with open-angle glaucoma or ocular hypertension.
Latanoprostene bunod (ophthalmic solution, 0.024%), a once-daily monotherapy, is the first nitric-oxide donating agent to be approved for ophthalmic use. When applied to the ocular surface, the compound is metabolized into 2 active agents: latanoprost acid, which acts on the uveoscleral outflow pathway; and NO, which acts on the trabecular meshwork and Schlemm’s canal.
Bausch + Lomb’s phase 3 LUNAR trial found that once-daily latanoprostene bunod therapy led to significantly better IOP reduction compared with twice-daily timolol at all time points. The most common side effects were conjunctival hyperemia, eye irritation and eye pain. Increased pigmentation of the iris and periorbital tissue and growth of eyelashes can occur.
"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," said Robert N. Weinreb, MD, director of the Hamilton Glaucoma Center at the University of California San Diego.
According to a press release from Valeant Pharmaceuticals, the parent company of Bausch + Lomb, Vyzulta will be available before the end of 2017.