FDA Approves Rhopressa, a New Therapy from Aerie Pharmaceuticals to Treat Glaucoma
Wednesday, December 20, 2017 12:21 AM
IRVINE, Calif.—Aerie Pharmaceuticals Inc.
(NASDAQ:AERI), an ophthalmic pharmaceutical company, said the Food and Drug Administration (FDA) has approved its new drug Rhopressa (netarsudil ophthalmic solution) 0.02%, which is indicated for lowering elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The FDA approval decision was made two months ahead of the scheduled PDUFA (Prescription Drug User Fee Act) goal date of Feb. 28, 2018, the company said in its announcement. Rhopressa is a once-daily eye drop.
“The approval of once-daily Rhopressa represents the single greatest achievement in Aerie’s history to date, and represents exciting news for patients with open-angle glaucoma or ocular hypertension, and physicians,” Aerie chairman and chief executive officer Vicente Anido Jr. said in a statement.
Anido noted the company is well-prepared for commercialization and will hire a sales force of 100 sales reps early in the first quarter. The plan is to launch the new treatment “by mid-second quarter of 2018,” he added, and “to make strides in gaining formulary coverage for commercial plans, which represent approximately half of the U.S. market.”
In addition, Aerie said it remains on track to file a new drug application for Roclatan in next year’s second quarter. Roclatan is a fixed-dose combination of Rhopressa and latanoprost for treatment of elevated IOP.
Anido added, “As we reflect on the Rhopressa approval, we pay tribute to Aerie’s late co-founder, Dr. David Epstein. He was a visionary in the field of glaucoma and always believed in the potential IOP-lowering benefits of Rho kinase inhibition. This is a fulfillment of his dream.”