FDA Approved Vyzulta(Latanoprostene Bunod Ophthalmic Solution)to Relieve Glaucoma, Ocular HTN

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

Vyzulta, a once-daily monotherapy, with a dual mechanism of action, it works by metabolizing into two moieties, latanoprost acidand butanediol mononitrate. Latanoprost acidworks within the uveoscleral pathway to increase aqueous humor outflow. Butanediol mononitrate releases NO to increase outflow through the trabecular meshwork and Schlemm’s canal.

In multiple clinical trialsthe safety and efficacy of Vyzulta were evaluated in phase 3 studies, APOLLO and LUNAR, JUPITER, and CONSTELLATION studiesand the Phase 2 VOYAGER study. When compared to Vyzulta with timolol maleate ophthalmic solution 0.5% in subjects (N = 831) with open-angle glaucoma or ocular hypertension, study data indicated statistically significant differences in intraocular pressure lowering. In the APOLLO and LUNAR studies (n=831), throughout the day at three months of treatmentVyzulta demonstrated significantly greater IOP reduction than timolol 0.5%, resulting in a reduction in mean diurnal IOP of 32% from baseline.

Studies have demonstrated that in normal eyes nitric oxide (NO) plays a role in controlling IOP by increasing aqueous humor outflow through the trabecular meshwork and Schlemm’s canal. The patients with glaucoma have reduced levels of nitric oxide (NO) signaling in their eyes, providing a rationale for the therapeutic value of nitric oxide (NO) releasing molecules for patients with open-angle glaucoma or ocular hypertension.

As per the study data,nitric oxide (NO) controls IOP in normal eyes by increasing aqueous humor outflow through the trabecular meshwork and Schlemm’s and demonstrated that patients with glaucoma have reduced levels ofnitric oxide (NO) signaling in their eyes which provides a rationale for the therapeutic value of nitric oxide (NO)releasing molecules for patients with ocular hypertensionor open-angle glaucoma.

Treatment with Vyzulta showed greater IOP reduction vs. Xalatan (latanoprost ophthalmic solution 0.005%) with differences reaching 1.23mmHg (P=0.005) for Vyzulta, in the VOYAGER study (n=413). In the Vyzulta arm it achieved a mean diurnal IOP ≤18mmHg vs. the Xalatan arm in more patients.

Additional Information:

Mechanism of Action:

The reduction of intraocular pressure or Vyzulta (latanoprostene bunod ophthalmic solution) it is a nitric oxide (NO) donating prostaglandin F2-alpha analog. By increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes is thought to lower intraocular pressure. The major modifiable risk factor for glaucoma progression is intraocular pressure. Reduction of intraocular pressure, which reduces the risk of glaucomatous visual field loss.

Adverse Effects:

The most common adverse effects associated with the use of Vyzulta may include conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%), but these are not limited. The growth of eyelashes, increased pigmentation of the periorbital tissue and iris and can also occur. As a result of any of the vital sign measurements or ocular sign assessments, no unexpected safety concerns were raised.

For more additional information about Vyzulta in patients with open-angle glaucoma or ocular hypertension, please visit http://www.vyzulta.com/hcp/

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