Bausch + Lomb Receives US FDA Approval for Vyzulta for IOP Reduction in Glaucoma Patients

November 3, 2017: By Jon Swedien

Bausch

The US FDA has approved the new drug application (NDA) for Bausch + Lomb’s Vyzulta for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, parent Valeant announced Nov. 2.

Vyzulta (latanoprostene bunod ophthalmic solution 0.024%), a nitric oxide-donating prostaglandin analog, is a once daily monotherapy.

Valeant CEO Joseph Papa said the company plans to launch Vyzulta by the end of 2017.

Nicox licensed Vyzulta to Bausch + Lomb on a global basis in 2010. As a result of the approval, Nicox will receive $17.5 million from Bausch + Lomb, and Nicox will make a $15 million payment to Pfizer under a previous license agreement, Valeant said.

Vyzulta’s approval was delayed twice because of problems at Bausch + Lomb’s manufacturing plant in Tampa, Florida. The FDA held up several ophthalmic drug candidates over plant concerns in 2016 and 2017.

Valeant resolved its issues, allowing the regulatory process to proceed.

In multiple clinical studies, Vyzulta outperformed timolol and latanoprost in lowering IOP, the company said.

Previously known as Vesneo, the drug was renamed Vyzulta in January.

The most common ocular adverse events associated with Vyzulta include conjunctival hyperemia, eye irritation, eye pain, and instillation site pain, Valeant said. Increased pigmentation of the iris and periorbital tissue and growth of eyelashes also can occur, Valeant said.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

Imprimis Will Comply with FDA Warning Letter

GenSight Receives UK Approval to Start Phase I/II Trial of Gene Therapy for Retinitis Pigmentosa

US FDA Outlines Compounding Policy, Defines Drugs that are ‘Essentially Copies’

Major US Hospitals Plan to Create Generic Drug Company, NYT Reports

Glaukos’ iDose Travoprost Implant Achieves Sustained IOP Reduction in 12-Month Interim Cohort

RXi Plans to Out-License Ophthalmic Segment or Find Development Partner

Bausch + Lomb Receives CE Marking for Stellaris Elite with Vitesse

Ohr’s Squalamine Combination Therapy Fails in Phase III Trial in Wet AMD

Iridex Sues Quantel Medical over Patent, Trademark Infringement

pSivida Submits NDA to US FDA for Durasert for Posterior Segment Uveitis

Alimera Sciences Refinances Debt with $40 Million Loan

LENSAR Acquires Mobile Laser Unit of Precision Eye Services

CES 2018 Features Dynafocals Smart Reading Glasses by PH Technical Labs

Novaliq Enrolls First Patient in Phase II Trial for Dry Eye Candidate, Establishes US Subsidiary

Allergan to Eliminate More than Thousand Jobs as Part of Restructuring

Spark Prices Luxturna at $850 Thousand, Looks to Offer Multiple Financing Plans

Oculis Raises $20.3 Million in Series B Round

Pixium Vision Gets Green Light for US Study of PRIMA Retinal Implant in Atrophic Dry AMD

Kala’s Dry Eye Candidate Meets Both Sign Endpoints, Misses One Symptom Endpoint in Phase III Studies

Pershing Square, Valeant Agree to Pay $290 Million in Settlement; Judge Will Decide Whether Deal is Fair

Coming soon

2018 Ophthalmic Surgical Instruments Report: A Global Market Analysis for 2017 to 2023