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Aerie Pharmaceuticals Receives Marketing Authorisation of Roclanda 50 micrograms/ml + 200 micrograms/ml Eye Drops, Solution (latanoprost + netarsudil) in Great Britain

Nachrichtenquelle: Business Wire (engl.)
19.04.2021, 12:30  |  118   |   |   

Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), 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, today announced that Roclanda 50 micrograms/ml + 200 micrograms/ml Eye Drops, Solution (latanoprost + netarsudil) (“Roclanda”) has received marketing authorisation from the Medicines and Healthcare Products Regulatory Agency (“MHRA”) in Great Britain. Roclanda is indicated for the reduction of elevated intraocular pressure (“IOP”) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction (reference Great Britain Summary of Product Characteristics).

Roclanda was granted a marketing authorisation by the European Commission (“EC”) in January 2021 for the same indication. The EC marketing authorisation is valid in all 27 countries of the European Union, plus Iceland, Norway and Liechtenstein. Through the EC marketing authorisation, Roclanda is also authorised in Northern Ireland. As the EC decision was received after the end of the Brexit transition period, Aerie was required to complete a further administrative step in order to obtain authorisation in Great Britain, which has now been granted.

“The authorisation of Roclanda in Great Britain, the only fixed-dose combination IOP-lowering therapy with a prostaglandin analogue that does not include a beta blocker, is another important regulatory milestone for Aerie on the heels of the receipt of the EC marketing authorisation for Roclanda in January,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “We continue to evaluate our potential collaboration opportunities in Europe and this authorisation is another important step in furthering those discussions.”

Roclanda was authorised by the U.S. Food and Drug Administration in March 2019 under the trade name Rocklatan for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.

About Aerie Pharmaceuticals, Inc.

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 U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) 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. More information about Rhopressa, including the product label, is available at www.rhopressa.com. 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, and instillation site pain. More information about Rocklatan, including the product label, is available at www.rocklatan.com. 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. More information is available at www.aeriepharma.com.

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Aerie Pharmaceuticals Receives Marketing Authorisation of Roclanda 50 micrograms/ml + 200 micrograms/ml Eye Drops, Solution (latanoprost + netarsudil) in Great Britain Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), 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 …

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