EMA Accepts Drug Application for Regulatory Approval of Rhokiinsa (Rhopressa)

Source: Aerie Pharmaceuticals

Aerie Pharmaceuticals reported that the European Medicines Agency (EMA) has accepted for review the 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 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,” Vicente Anido, Jr, PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “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. In addition to our manufacturing facility in Ireland, we are building our clinical, medical affairs and commercial teams in the European region. Additionally, we were well-represented at the recent 36thCongress of the European Society of Cataract and Refractive Surgeons in Vienna, including an active booth and our presentations and panel participation at the Ophthalmology Futures Forums.

Dr. Anido continued, “Separately, our plans remain on schedule for the initiation of our phase 2 clinical trial for Rhopressa in Japan early next year, including the opening of an Aerie office in Tokyo.”

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