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FDA Approves Vyzulta for Glaucoma, Ocular Hypertension
The FDA has approved latanoprostene bunod ophthalmic solution, 0.024% (Vyzulta, Bausch + Lomb) for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Vyzulta, a once-daily monotherapy, is the first prostaglandin analog that has nitric oxide (NO) as one of its metabolites. Following topical administration, Vyzulta works by metabolizing into two moieties, latanoprost acid, which primarily works within the uveoscleral pathway to increase aqueous humor outflow, and butanediol mononitrate, which releases NO to increase outflow through the trabecular meshwork and Schlemm's canal.
In glaucoma patients, damage to the trabecular meshwork, through which the majority of the aqueous humor passes, can lead to reduced drainage and as a result elevated IOP. Lowering IOP, even in patients with normal baseline levels, can delay or even prevent damage to optic nerves, helping to reduce the risk of glaucomatous visual field loss.
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.
The efficacy and safety of Vyzulta were evaluated in two randomized, multicenter, double-masked, parallel-group phase 3 studies, APOLLO and LUNAR, comparing Vyzulta with timolol maleate ophthalmic solution 0.5% in subjects (N = 831) with open-angle glaucoma or ocular hypertension. Vyzulta demonstrated significantly greater IOP lowering than timolol 0.5% throughout the day at three months of treatment, resulting in a reduction in mean diurnal IOP of 32% from baseline.
The most common ocular adverse events included conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). Increased pigmentation of the iris and periorbital tissue and growth of eyelashes can also occur. No unexpected safety concerns were raised as a result of any of the ocular sign assessments or vital sign measurements.
Bausch + Lomb is a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. Nicox S.A. licensed Vyzulta on a global basis to Bausch + Lomb.
Source: Valeant; November 2, 2017.