Aerie Pharmaceuticals Inc. expects to resubmit the new drug application for Rhopressa near the end of the first quarter of 2017.
Rhopressa is a novel eye drop that, if approved, could become the only once-daily product available that, based on preclinical studies, specifically targets the trabecular meshwork, the eye's primary fluid drain and the diseased tissue responsible for elevated intraocular pressure in glaucoma.
The company received notification from its third-party manufacturing vendor that the manufacturing line related to Rhopressa in their Tampa, Fla., facility will not be ready for pre-approval inspection by the U.S. FDA until the end of February 2017. The manufacturer had previously advised Aerie and the FDA that it expected to be prepared for the inspection in January 2017.
In October, Rhopressa's new drug application was withdrawn due to the manufacturer not being prepared for pre-approval inspection by the FDA.
The delay does not result from any new findings, but rather additional time needed to complete validation of new equipment.
Aerie will resubmit the new drug application once the manufacturing line related to Rhopressa is ready for inspection.