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Policy & Regulation
European Medicines Accepts Drug Application for Aerie Pharmaceuticals' Rhokiinsa
10 October 2018 - - The European Medicines Agency has accepted for review the MAA for Rhokiinsa (netarsudil ophthalmic solution) 0.02%, US-based ophthalmic pharmaceutical company Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) said.
Rhokiinsa is currently marketed as Rhopressa in the United States and is indicated for the reduction of elevated intraocular pressure 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.
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, retina diseases and other diseases of the eye.
Aerie's first product, Rhopressa, a once-daily eyedrop 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, cornea verticillata, instillation site pain, and conjunctival hemorrhage.
Aerie's advanced-stage product candidate, Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost, achieved its 3-month primary efficacy endpoint in two Phase 3 registration trials, Mercury 1 and Mercury 2, and also showed safety and efficacy throughout 12 months in Mercury 1.
Aerie submitted the Roclatan New Drug Application in May 2018 and, in July 2018, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA's review of the Roclatan NDA for March 14, 2019.
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.
Rhokiinsa is currently marketed as Rhopressa in the United States and is indicated for the reduction of elevated intraocular pressure 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.
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, retina diseases and other diseases of the eye.
Aerie's first product, Rhopressa, a once-daily eyedrop 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, cornea verticillata, instillation site pain, and conjunctival hemorrhage.
Aerie's advanced-stage product candidate, Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost, achieved its 3-month primary efficacy endpoint in two Phase 3 registration trials, Mercury 1 and Mercury 2, and also showed safety and efficacy throughout 12 months in Mercury 1.
Aerie submitted the Roclatan New Drug Application in May 2018 and, in July 2018, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA's review of the Roclatan NDA for March 14, 2019.
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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