Valeant announced that the Food and Drug Administration (FDA) has approved Vyzulta (latanoprostene bunod) ophthalmic solution for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Vyzulta is a prostaglandin analog with nitric oxide as one of its metabolites. This once-daily therapy exerts a dual mechanism of action through latanoprost acid, which works within the uveoscleral pathway to increase aqueous humor outflow, and through butanediol mononitrate, which releases nitric oxide to increase outflow through the trabecular meshwork and Schlemm’s canal.
The safety and efficacy of Vyzulta have been evaluated in multiple clinical trials: Phase 3 APOLLO, LUNAR, JUPITER, and CONSTELLATION studies, and the Phase 2 VOYAGER study. Study data indicated statistically significant differences in intraocular pressure lowering when compared to timolol and latanoprost. Treatment with Vyzulta demonstrated significantly greater IOP reduction than timolol 0.5% throughout the day at 3 months of treatment (mean diurnal IOP 32% reduction) in the APOLLO and LUNAR studies (n=831).
In the VOYAGER study (n=413), treatment with Vyzulta showed greater IOP reduction vs. Xalatan (latanoprost ophthalmic solution 0.005%) with differences reaching 1.23mmHg (P=0.005) for Vyzulta. Also, more patients in the Vyzulta arm achieved a mean diurnal IOP ≤18mmHg vs. the Xalatan arm.
In the JUPITER study (n=130), treatment with Vyzulta led to a 22% mean reduction in IOP at Week 4, which was sustained through Week 52. At Week 52, the data showed a 26% reduction from baseline in the study eye.
In the CONSTELLATION study, treatment with Vyzulta lowered IOP over 24 hours with a significantly greater nocturnal IOP reduction vs. timolol (P<0.004). Also, Vyzulta-treated patients reported improved daytime ocular perfusion pressure (OPP) vs. baseline (P<0.001) and nocturnal OPP vs. timolol 0.5%(P=0.01) over a 24-hour period.
“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,” stated Robert N. Weinreb, MD, chairman and distinguished professor of Ophthalmology and director, Hamilton Glaucoma Center at the University of California San Diego.
Conjunctiva hyperemia, eye irritation, eye pain, and instillation site pain were reported as the most common ocular adverse events.
Vyzulta will be available as a 0.024% ophthalmic solution in 7.5mL bottles (5mL fill volume). It is anticipated to launch before the end of 2017.
For more information call (800) 321-4576 or visit Vyzulta.com.