Early FDA approval for glaucoma drug Rhopressa

The US Food and Drug Administration has approved Rhopressa (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, from ophthalmic drug specialist Aerie Pharmaceuticals (Nasdaq: AERI).

The FDA approval decision was made two months ahead of the scheduled PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018

The approval was widely expected as, in a unanimous vote in October, an FDA advisory committee backed the drug. Trading in Aerie’s shares was halted ahead of the announcement, but they then declined about 3% in late trading to $57.25.