Cayman Chemical Receives CEP for Latanoprost API from EDQM
Thea Pharma’s work to eliminate preservatives from latanoprost formulations has landed it an FDA nod in open-angle glaucoma and ocular hypertension, clearing the company to launch a differentiated rival to the incumbent eye drops.
Thea Pharma Announces FDA Approval of IYUZEH™ for the Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-angle Glaucoma or Ocular Hypertension
Alcon Completes Acquisition of Aerie Pharmaceuticals, Inc., Strengthening Company’s Ophthalmic Pharmaceutical Business
CHICAGO, Sept. 29, 2022 (GLOBE NEWSWIRE) -- TearClear, an ophthalmic pharmaceutical company that transforms trusted drugs into branded best-in-class therapies, announced today that the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%) met the primary and all secondary endpoints in the CLEAR Phase 3 pivotal trial. With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023. Upon approval, TC-002 will offer patients the first and only means of delivering preservative-free doses of latanoprost from conventional multi-dose bottles.
Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), a pharmaceutical company focused on the discovery, development, and commercialization of first-in-class ophthalmic therapies, today announced that the first participant has been dosed in the Phase 3 registrational “COMET-3” study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye disease (DED). COMET-3 is the second of three trials in the Phase 3 registrational program for AR-15512. Aerie plans to initiate the last of the trials, the COMET-4 safety study, in the fourth quarter of 2022. Aerie intends to complete the AR-15512 registrational program in 2023 and, assuming clinical success, plans to file a New Drug Application (NDA) with the FDA in 2024.
FDA Confirms Paragraph IV Patent Litigation for Latanoprost & Neutarsudil Dimesylate
BOSTON, Feb. 07, 2022 (GLOBE NEWSWIRE) -- TearClear, a late clinical stage ophthalmic pharmaceutical company, is pleased to announce the TC-002 Phase 3 trial has been successfully initiated. TearClear’s Phase 3 trial (CLEAR Study) is a prospective, double-masked, randomized, multi-center, active-controlled, parallel-group, 3-month study assessing the safety and ocular hypotensive efficacy of TC-002 Ophthalmic Solution (TearClear Preservative-Free Latanoprost Ophthalmic Solution 0.005%) compared to marketed Latanoprost Ophthalmic Solution 0.005%.