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European Regulators Accept Rhopressa Application

■ Aerie Pharmaceuticals reported that the European Medicines Agency (EMA) has accepted for review the MAA for Rhokiinsa (netarsudil ophthalmic solution) 0.02%. Since April, Rhokiinsa has been marketed as Rhopressa in the United States and is indicated for the reduction of elevated IOP 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., PhD, chairman and CEO at Aerie. “Our Mercury 3 phase 3 trial for Roclatan, Aerie’s fixed-dose combination of Rhopressa and latanoprost, is ongoing in several European countries, and we continue to expand our presence in Europe with nearly 60 employees on board.”

Aerie also plans to initiate a phase 2 trial of Rhopressa in Japan in 2019.