IOP DRUG UNDER REVIEW
Pharmaceuticals has reported that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%.
Rhokiinsa is currently marketed as Rhopressa® in the United States and is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. An opinion from the EMA’s Committee for Medicinal Products for Human Use on the MAA for Rhokiinsa is expected in the second half of 2019.
“We are delighted that the European regulatory authorities have accepted our Rhokiinsa filing for review. If Rhokiinsa is approved, we plan to submit an MAA for Roclatan™ shortly thereafter,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. www.aeriepharma.com