The dermatologic and ophthalmic drugs advisory committee voted unanimously that clinical trials support the efficacy of Aerie’s netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nine members of the committee voted to say that the product’s efficacy outweighs its safety risks, while one member voted against that claim.
The committee also discussed the draft product labeling suggested by the FDA. Aerie said it plans to continue that conversation with the FDA.
“We are delighted with the outcome of the FDA’s advisory committee, and we now have our sights set on the February 28th PDUFA date,” chairman & CEO Vicente Anido said in prepared remarks. “We believe there are significant unmet needs in the treatment of patients with open-angle glaucoma or ocular hypertension, and we are very excited about the prospects for Rhopressa.”
The Irvine, Calif.-based company submitted its Rhopressa NDA in February and the FDA is slated to finishing reviewing the application by Feb. 28, 2018.
The NDA under review is a resubmitted application – the initial NDA for Aerie’s Rhopressa eye drops was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection.
In August this year, Aerie said 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, but Aerie reported that it doesn’t think the manufacturer’s regulatory obstacle will impact the decision deadline for Rhopressa.