Research & Development
Aerie Pharmaceuticals Submits Marketing Authorisation Application for Roclanda 0.02%/0.005% in Europe
6 December 2019 - - US-based ophthalmic pharmaceutical company Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) has submitted the marketing authorisation application for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% with the European Medicines Agency.

Should the MAA for Roclanda be accepted for review by the EMA, an opinion from the Committee for Medicinal Products for Human Use is expected in approximately 12 months.

Roclanda is currently marketed in the United States as Rocklatan.

The MAA submission for Roclanda was predicated on the receipt of a marketing authorisation for Rhokiinsa (netarsudil ophthalmic solution) 0.02%, which the European Commission granted in November 2019. Rhokiinsa is marketed as Rhopressa in the United States.

Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye.

Aerie's first product, Rhopressa (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the US Food and Drug Administration for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018.

In clinical trials of Rhopressa, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.

Aerie's second product for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost, was approved by the FDA and was launched in the United States in the second quarter of 2019.

In clinical trials of Rocklatan, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.
Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema.
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