Vyzulta (latanoprostene bunod ophthalmic solution)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved November 2017

Specific Treatments:

reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Therapeutic Areas

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General Information

Vyzulta (latanoprostene bunod ophthalmic solution) is a nitric oxide-donating prostaglandin F2-alpha analog.

Vyzulta is specifically indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. 

Vyzulta is supplied as a solution for topical ophthalmic administration. The recommended dosage is one drop in the conjunctival sac of the affected eye(s) once daily in the evening.  Do not administer Vyzulta 0.024% more than once daily as t has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect. If Vyzulta is to be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure, administer each drug product at least five (5) minutes apart. 

 

Clinical Results

FDA Approval

The FDA approval of Vyzulta was based on two randomized, multi-center, double-masked, parallel-group Phase III studies, APOLLO and LUNAR, comparing Vyzulta with timolol maleate ophthalmic solution 0.5% in subjects (N=831) with open-angle glaucoma or ocular hypertension. The primary objective of these studies was to demonstrate that the mean IOP reduction over 3 months of treatment with Vyzulta once daily (QD) in the evening was non-inferior to timolol 0.5% twice daily (BID). A secondary objective was to demonstrate the superiority of Vyzulta QD to timolol 0.5% BID. In both studies, Vyzulta met the primary efficacy endpoint. VYZULTA also demonstrated significantly greater IOP lowering than timolol 0.5% throughout the day at 3 months of treatment resulting in a reduction in mean diurnal IOP of 32% from baseline.

In addition, in a phase II study, VOYAGER, (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. More subjects in the Vyzulta arm achieved a mean diurnal IOP ≤18mmHg vs. the Xalatan arm. In the phase III 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 phase III CONSTELLATION study, treatment with Vyzulta lowered IOP over 24 hours with a significantly greater nocturnal IOP reduction vs. timolol (P<0.004). 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.

Side Effects

Adverse effects associated with the use of Vyzulta may include, but are not limited to, the following:

  • conjunctival hyperemia
  • eye irritation
  • eye pain
  • instillation site pain

Mechanism of Action

Vyzulta (latanoprostene bunod ophthalmic solution) is a nitric oxide-donating prostaglandin F2-alpha analog. Latanoprostene bunod is thought to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes.  Intraocular pressure is a major modifiable risk factor for glaucoma progression. Reduction of intraocular pressure reduces risk of glaucomatous visual field loss

Additional Information

For additional information regarding Vyzulta or the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, please visit http://www.vyzulta.com/hcp/