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

Bausch + Lomb Launches Stellaris Elite for Retinal Surgery in US

Sentencing Delayed for Florida Retina Specialist Melgen

Valeant Receives FDA Complete Response Letter for Vyzulta

US FDA Clears Optovue Software for Corneal Epithelial Thickness Mapping

Ocular Therapeutix Names Daniel Bollag as Regulatory Chief

Eylea Sales Continue to Increase; Lucentis Gains New Indications

RXi Pharmaceuticals Signs Common Stock Purchase Agreement for Up to $15 Million

Allegro’s Luminate Posts Positive Results in Phase IIb Stage 2 Trial for Diabetic Macular Edema

Omeros’ Omidria Revenues Grow 71 Percent

AGTC Receives US FDA Orphan Drug Designation for Gene Therapy to Treat X-Linked Retinitis Pigmentosa

Aerpio Shares Begin Trading on OTCQB Market

Aerie Reports FDA Concerns over Contract Manufacturer’s Plant

Valeant’s Bausch + Lomb Revenues Dip 3 percent in Q2-2017

Ocular Therapeutix Reports $66 Million in Cash, Cash Equivalents

Imprimis’ Q2-2017 Ophthalmology Revenues Increase 70 percent

Carl Zeiss Meditec’s Revenues Grow 7.5 Percent in Latest Quarter

Johnson & Johnson Vision to Acquire TearScience

Mynosys Receives $1 Million Grant from NEI to Commercialize Zepto

Ocular Therapeutix Eliminates 26 Positions; New CEO Takes Helm

Inotek Stops Development of Trabodenoson after Second Failed Study

Coming soon

2017 Glaucoma Pharmaceuticals Report: A Global Market Analysis for 2016 to 2022