11 January 2021 - - The European Commission has granted a marketing authorisation for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction, US-based ophthalmic pharmaceutical company Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) said.

The marketing authorisation application for Roclanda was accepted for review by the European Medicines Agency in January 2020.

Aerie received a positive scientific opinion recommending approval of the Roclanda MAA from the EMA's Committee for Medicinal Products for Human Use in November 2020.

Roclanda was approved by the US Food and Drug Administration in March 2019 under the trade name Rocklatan for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Rhokiinsa was granted a marketing authorisation by the EC in November 2019 for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension.

Rhokiinsa was approved by the FDA in December 2017 under the trade name Rhopressa for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The marketing authorisation is valid in all 27 countries of the European Union, plus Iceland, Norway and Liechtenstein.

As the EC decision was received after the end of the Brexit transition period, Aerie will complete a further administrative step in order to obtain a license in the United Kingdom.

No reexamination of clinical data by the UK Medicines and Healthcare Products Regulatory Agency is expected.

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, ocular surface diseases and retinal diseases.

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 launched in the United States in May 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.