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Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. This therapy aims to reduce elevated intraocular pressure in adults with primary open-angle glaucoma or ocular hypertension. A final decision from the European Commission is anticipated in about two months, which will affect all EU member states and additional countries.
Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic pharmaceutical company, announced that CEO Vicente Anido, Jr., Ph.D., will participate in a fireside discussion at the Stifel 2020 Virtual Healthcare Conference on November 17, 2020, at 8:00 a.m. ET. The session will offer an overview of Aerie and update on its business. The discussion will be webcast live on Aerie's website and available for replay for 10 business days. Aerie is focused on developing first-in-class therapies for open-angle glaucoma and ocular diseases, having launched products like Rhopressa® and Rocklatan®.
Aerie Pharmaceuticals (NASDAQ:AERI) reported a third-quarter 2020 net loss of $39.6 million or $0.86 per share, improved from a $49.4 million loss in Q3 2019. Net product revenues reached $20.1 million, up from $18.5 million a year earlier. The U.S. glaucoma franchise saw over 12% growth in volumes, driven by Rhopressa® and Rocklatan®. The company holds $218 million in cash, with a $50 million upfront payment expected from Santen for collaboration in Asia. Aerie anticipates initiating its first Phase 3 clinical trial for Rhopressa® in Japan by year-end.
Aerie Pharmaceuticals (NASDAQ: AERI) has initiated the COMET-1 Phase 2b clinical trial for AR-15512, a TRPM8 agonist ophthalmic solution aimed at treating dry eye disease. The randomized trial expects to enroll approximately 360 patients, testing the efficacy and safety of AR-15512 against a vehicle. Primary endpoints include ocular discomfort and tear production over three months, with results anticipated in Q3 2021. This trial marks Aerie's entry into dry eye treatment, addressing an unmet need for over 30 million sufferers in the U.S.
Santen Pharmaceutical and Aerie Pharmaceuticals have formed an exclusive agreement for the development and commercialization of Rhopressa® and Rocklatan® in Japan and other Asian countries. Aerie will receive an upfront payment of $50 million alongside milestone payments of up to $99 million, plus royalties exceeding 25% of net sales. Santen handles marketing and sales, while both companies will collaborate on the Phase 3 study of Rhopressa® in Japan. This partnership leverages Santen's strong market presence in ophthalmology to enhance glaucoma treatment options.
Aerie Pharmaceuticals (NASDAQ:AERI) will release its third quarter 2020 financial results after market close on November 5, 2020. A live conference call will follow at 5:00 p.m. ET for a discussion of the results and a general business update. Aerie focuses on developing first-in-class therapies for open-angle glaucoma, ocular surface diseases, and retinal diseases. The company launched Rhopressa® in April 2018 and Rocklatan® in May 2019, both aimed at reducing elevated intraocular pressure (IOP).
Aerie Pharmaceuticals (NASDAQ: AERI) announced that the FDA has approved the IND for AR-15512, a TRPM8 agonist eye drop intended for treating dry eye. This decision enables Aerie to launch clinical trials, starting with a Phase 2b study expected in Q4 2020. AR-15512, previously known as AVX-012, was acquired from Avizorex Pharma in 2019. The product aims to enhance tear production and alleviate discomfort associated with dry eye disease. The company anticipates reporting topline results in Q3 2021, marking a significant milestone in Aerie's product development pipeline.
