Valeant Receives FDA Complete Response Letter for Vyzulta

August 11, 2017: By Jon Swedien

1 Ophthalmic NewsValeant Pharmaceuticals International has received a complete response letter (CRL) from the US FDA in response to its new drug application (NDA) for Vyzulta, the Canadian company announced Aug. 7.

Vyzulta (latanoprostene bunod ophthalmic solution 0.024%) is a nitric oxide-donating prostaglandin analog intended to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

According to Valeant, the CRL references a current good manufacturing practice (CGMP) inspection at a Tampa, Florida, manufacturing facility belonging to its Bausch + Lomb subsidiary.

The company said the FDA did not identify any efficacy or safety concerns or request additional clinical trials for NDA approval.

Valeant said it will work closely with the agency to determine the next steps.

The US FDA had set a target action date of Aug. 24, 2017, for its decision on Vyzulta.

Bausch + Lomb and Nicox are co-developing the drug candidate. The two companies had resubmitted the NDA in early March after addressing concerns the FDA raised in a 2016 inspection of the Tampa facility.

Bausch + Lomb licensed the product candidate from Nicox in March 2010 and rebranded the drug Vyzulta in January. It was previously branded Vesneo.

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

Refocus Completes PMA Application for VisAbility as Treatment for Presbyopia

Novaliq’s NovaTears+Omega-3 Approved in Europe for Dry Eye

CooperVision Acquires Paragon Vision Sciences for $80 Million

AYOXXA Biosystems Launches Test for Biomarkers in Retinal Disease

Glaukos Announces New Patent for Glaucoma Stent Implanted in Schlemm’s Canal

Fortress Biotech Forms Tamid Bio Subsidiary; Lead Candidate is Ophthalmic Gene Therapy for MPS I

Samsung Launches App that Adjusts QLED TV Settings for Color-blind Viewers

Solar Eclipse Burns Crescent Wound in Woman’s Unprotected Retina

US Judge Refuses to Dismiss Allergan Suit against Imprimis

BioLight Sells IOPtima to Chengdu Kanghong Pharmaceutical Group for $56 Million

Regeneron Ending Eylea, Nesvacumab Combo Program

UK Retinal Drugmaker Exonate Forms Clinical Advisory Board

US FDA Approves RxSight’s Light Adjustable Lens and Light Delivery Device

EMA to Move to Amsterdam due to Brexit

First Subject Dosed in Nevakar’s Phase III Trial of NVK-002 for Myopia in Children

ProQR Doses First Patient in Phase I/II Trial for Leber’s Congenital Amaurosis 10

Aston EyeTech Raises $6.6 Million in Series A Equity Round

Ellex Raises $17.7 Million in Private Placement

Genentech’s Lampalizumab Fails Second Phase III Study in Geographic Atrophy

Judge Declares Mistrial in Corruption Trial of Melgen, Menendez

Coming soon

2017 Dry Eye Products Report: A Global Market Analysis for 2016 to 2022