Aerie Reports FDA Concerns over Contract Manufacturer’s Plant

August 11, 2017: By Jon Swedien

1 Ophthalmic NewsThe US FDA recently flagged manufacturing problems at the Tampa, Florida, plant that Aerie Pharmaceuticals uses as a contract manufacturer for Rhopressa, the Irvine, California, company announced Aug. 8.

Aerie said, “We currently believe it is probable that open issues will be resolved prior to the Feb. 28, 2018, target action date for Rhopressa.”

Aerie said it was given notice from the contract manufacturer that it received a complete response letter (CRL) from the FDA regarding a new drug application (NDA) for one of its own product candidates made at its Tampa facility.

Aerie did not name the contract manufacturer, though Valeant Pharmaceuticals announced on Aug. 7 that it received a CRL from the FDA in response to subsidiary Bausch + Lomb’s NDA for Vyzulta after the agency flagged issues at B+L’s manufacturing facility in Tampa.

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

FDA Advisory Panel Recommends Aerie’s Rhopressa for Glaucoma Patients

FDA Panel Unanimously Backs Spark’s Luxturna as Retinal Gene Therapy

PanOptica Secures $11 Million to Advance Topical Anti-VEGF Eye Drop for Neovascular AMD

Nicox and pSivida to Collaborate to Develop a Sustained Release Drug to Lower IOP

Azura Nets $16 Million in Series B Funding for Dry Eye Treatment

Alcon’s AcrySof Intraocular Lens Reaches 100 Million Implants

Notal Vision’s ForeseeHome Reaches Milestone of 3 Million Tests

FDA to Review Spark’s Retinal Gene Therapy Candidate Oct. 12

Alcon’s AutonoMe IOL Injector Gains CE Mark Approval

Shire Sues Allergan, Claiming Bundling Tactics Block Restasis Competitors

Allergan Decries ‘Unfair’ Patent Challenge Process as US House Launches Probe of Tribe Deal

FDA Warns that Vancomycin Eye Injections May Lead to Blindness

Alcon to Launch Clareon IOL at ESCRS Meeting

Bribery Trial Testimony Focuses on Melgen’s Billing for Lucentis

VSY Biotechnology to Launch AcrivaUD Trinova Trifocal IOL at ESCRS Meeting

Valeant Launches $1 Billion Private Senior Notes Offering

STAAR Surgical Appoints Scott Barnes, MD, as New CMO

Aerie Acquires Envisia Technology for $25M to Advance Retinal Program

Carl Zeiss Meditec Announces Milestone of 1 Million SMILE Procedures

Maryland Team Wins First Phase of NEI Contest to Create Human Retina

Coming soon

2017 Refractive Surgery Report: A Global Market Analysis for 2016 to 2022