Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates.
The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA is set to approve or reject by February of next year. Aerie reported that it doesn’t think the manufacturer’s regulatory obstacle will impact the decision deadline for Rhopressa.
“Based on Aerie’s understanding of the contract manufacturer’s CAPA (Corrective and Preventative Actions) and other activities at the manufacturing site, and PDUFA dates later in 2017 for other products manufactured at that site, we currently believe it is probable that open issues will be resolved prior to the February 28, 2018 PDUFA date for Rhopressa,” the company said in prepared remarks.
The unnamed contract manufacturer reportedly told Aerie that it is working closely with the FDA to determine next steps.
In March, Aerie resubmitted a New Drug Application for the company’s Rhopressa eye drops. The initial NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection.
Aerie shares held steady last week after the pharmaceutical company missed EPS estimates on Wall Street with its second quarter results.
The Irvine, Calif.-based company posted a net loss of -$28.4 million, or -82¢ per share, with its bottom line down -22.5% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -63¢, a penny behind consensus on The Street.