Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval […]
Optical/Ophthalmic
Clearside enrolls first patient in phase III trial of Zuprata combination therapy
Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the 1st patient in a phase III trial evaluating Zuprata, its suspension formulation of triamcinolone acetonide, in combination with Eylea, intravitreal aflibercept, for the treatment of macular edema associated with retinal vein occlusion. The trial is slated to enroll 460 patients with retinal vein occulsion to assess […]
pSivida shares gain on Q2 earnings
Shares in pSivida (NSDQ:PSDV) rose yesterday after the medical device maker met expectations on Wall Street with its fiscal 2nd quarter results. The Watertown, Mass.-based company pared its losses to -$0.1 million, or 0¢ per share, on sales of $6 million for the 3 months ended Dec. 31, for bottom-line growth of 98.7% on sales […]
Aura Biosciences wins FDA nod for light-activated ocular melanoma treatment
Aura Biosciences said today that the FDA approved its Investigational New Drug Application for the company’s light-activated viral nanoparticle conjugates for the treatment of ocular melanoma. The federal watchdog’s approval allows Cambridge, Mass.-based Aura to move forward with initial clinical tests of AU-011. The Phase Ib open-label clinical trial, which is currently enrolling, is designed to […]
Report: Novartis eyes sale for Alcon lens business
Novartis (NYSE:NVS) said yesterday that it is considering selling its Alcon eye care business and will buy back up to $5 billion worth of shares over the next 12 months, in an effort to reorganize after a tough year. The company’s profits dropped -11% to $936 million in the 3 months ended Dec. 31, while sales […]
Ocular Therapeutix looks to raise $25m in public offering
Ocular Therapeutix (NSDQ:OCUL) said today that it launched a $25 million underwritten public offering of its common stock. The Bedford, Mass.-based company did not provide any specific pricing details for the offering. Cantor Fitzgerald & Co. is the sole bookrunner for the offering, according to regulatory filings. Yesterday, the company said today that it resubmitted a […]
Ocular Therapeutix resubmits NDA for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval for the […]
Clearside Biomedical names Beckman as new CMO | Personnel Moves, Jan. 5, 2017
Clearside Biomedical (NSDQ:CLSD) today named Dr. Richard Beckman as chief medical officer. Beckman is an ophthalmologist with 13 years of clinical practice under his belt, as well as 20 years of corporate executive and consultancy experience. Prior to joining Clearside, Beckman managed a pharmaceutical and medical device industry consulting firm. He has also served as […]
Ocular Therapeutix touts data from phase III trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) touted interim data today from its phase III trial of Dextenza for the treatment of post-surgical ocular inflammation and pain. The bioresorbable intracanalicular hydrogel plug is designed to release drugs at the ocular surface for up to 30 days. The company announced last month that Dextenza met the trial’s 2 primary efficacy endpoints: […]
BioTime and subsidiary establish cell manufacturing facility in Israel
BioTime Inc. (NYSE:BTX) and its subsidiary Cell Cure Neurosciences said today that it is establishing an 800 square meter cell manufacturing facility at the Hadassah University Hospital in Jerusalem. The manufacturing center will be staffed initially by 30 employees, according to the companies, and will be prepared to produce OpRegen for BioTime’s ongoing clinical trial […]
