FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Vyzulta (latanoprostene bunod ophthalmic)

Indication:

Reduction of elevated intraocular pressure (IOP) caused by open-angle glaucoma or ocular hypertension.

Mechanism:

Prostaglandin agonist. Lowers IOP by increasing outflow of aqueous humor through the trabecular meshwork and uveoscleral routes. 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.

Dosage:

Instill 1 drop (0.024% ophthalmic solution) in affected eye(s) once daily in evening.

Approval was based on the LUNAR and APOLLO phase III clinical trials. Latanoprostene bunod significantly lowered mean IOP compared with timolol at all evaluation time points with a mean IOP ≤18 mmHg and IOP reduction ≥25% from baseline (P<0.001).

References:

Medeiros FA, et al. Comparison of latanoprostene bunod 0.024% and timolol maleate 0.5% in open-angle glaucoma or ocular hypertension: the LUNAR study. Am J Ophthalmol. 2016 Aug;168:250-59.

Weinreb RN, et al. Latanoprostene bunod 0.024% versus timolol maleate 0.5% in subjects with open-angle glaucoma or ocular hypertension: the APOLLO study. Ophthalmology. 2016 May;123(5):965-73.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.