FDA OKs Vyzulta for Glaucoma, Ocular Hypertension

Megan Brooks

November 06, 2017

The US Food and Drug Administration (FDA) has approved latanoprostene bunod ophthalmic solution 0.024% (Vyzulta, Bausch & Lomb/Nicox SA) for reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Latanoprostene bunod has a dual mechanism of action. It is rapidly metabolized in situ to latanoprost acid, which primarily works within the uveoscleral pathway to increase aqueous humor outflow, and butanediol mononitrate, which releases nitric oxide (NO) to increase outflow through the trabecular meshwork and Schlemm's canal, the companies explain in a news release.

Latanoprostene bunod, the first prostaglandin analogue that has NO as one of its metabolites, provides "consistent and sustained" reduction in IOP through 12 months, they said.

Studies have shown that levels of NO signaling are reduced in the eyes of patients with glaucoma, a finding that provides "a rationale for the therapeutic value of NO-releasing molecules for patients with open-angle glaucoma or ocular hypertension," they point out.

The safety and efficacy of Vyzulta have 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 the release.

"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," 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. Full prescribing information is available online.

Vyzulta is expected to be available before the end of the year.

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