Former Allergan exec to ensure Aerie gets vital launch right

Ophthalmic drug specialist Aerie Pharmaceuticals (Nasdaq: AERI) has appointed Julia Williams as director of medical affairs, initially focused on the launch of Rhopressa (netarsudil ophthalmic solution) 0.02%.

Last month, the US Food and Drug Administration (FDA) approved Rhopressa for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, a decision made two months ahead of the scheduled PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018. Aerie had initially been forced to withdraw its regulatory submission in October 2016, when it became clear that the contract manufacturer was not ready for a site inspection. The package was  resubmitted to the FDA in March.

Aerie plans to launch this product by mid-second quarter of 2018, and is also developing Roclatan, a combo therapy comprising Rhopressa plus Pfizer’s (NYSE: PFE) Xalatan (latanoprost). The Roclatan New Drug Application submission is also expected to take place in the second quarter of 2018.