Aerie Pharmaceuticals wavers on Rhopressa production line questions

Shares of US drugmaker Aerie Pharmaceuticals (Nasdaq; AERI) were down more than 5% in pre-market trade Friday, but levelled back to $37.30 by late morning, after it revealed that  the manufacturing line related to its glaucoma treatment Rhopressa (netarsudil ophthalmic solution) will not be ready in time for pre-approval inspection by the Food and Drug Administration.

The company said it has been notified by its third party manufacturing vendor that the manufacturing line related to Rhopressain its Tampa, Florida facility will not be ready for pre-approval inspection by the FDA until the end of February 2017.

In October this year, the Rhopressa New Drug Application (NDA) was withdrawn due to the contract drug product manufacturer not being prepared for pre-approval inspection by the FDA. The contract drug product manufacturer had previously advised Aerie and the FDA that it expected to be prepared for FDA inspection in January 2017. The delay apparently does not result from any new findings, but rather additional time needed to complete validation of new equipment.