Inotek Pharmaceuticals (NSDQ:ITEK) said last week that its glaucoma drug failed in a Phase II trial. This marks the 2nd problem for Inotek’s drug this year, after it failed in a late-stage trial comparing it to a placebo in January. In response to the data, CEO David Southwell said in a statement that the company […]
Optical/Ophthalmic
Ocular Therapeutix faces more manufacturing problems as FDA decision deadline looms
Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant. This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel plug, Dextenza, […]
Second Sight Medical wins expanded CMS coverage for Argus II
Second Sight Medical (NSDQ:EYES) said today its Argus II retinal prosthesis system won expanded reimbursement coverage from the Centers for Medicare and Medicaid Services in 11 additional states and the District of Columbia. With the expansion, the Sylmar, Calif.-based company said it’s Argus II device is now reimbursable in 7 of the 12 Medicare Administrative Contractor jurisdictions, […]
pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency. Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of […]
Novartis trial results could spell trouble for Regeneron
Head-to-head late-stage clinical trials published on Tuesday showed that a Novartis (NYSE:NVS) drug to treat patients with neovascular age-related macular degeneration doesn’t need to be injected as frequently as a rival drug from competitor Regeneron (NSDQ:REGN). Analysts reportedly said the data gives Novartis’ treatment, RTH258, a competitive edge compared to its rival therapies. Get the full […]
Glaukos touts iStent study with topical travoprost
Glaukos (NYSE:GKOS) touted data today from a 53-patient glaucoma study showing that its iStent device combined with topical travoprost reduced mean intraocular pressure by 35% after 18 months of follow-up. The company’s flagship device is designed to lessen IOP by restoring the natural outflow of aqueous humor through the conventional pathway in a patient’s eye. […]
pSivida implant meets primary endpoint in late-stage trial
pSivida (NSDQ:PSDV) touted data from the 2nd Phase III trial of its Durasert 3-year treatment for posterior segment uveitis. The company reported that the trial, which followed patients for 3 years, met its primary endpoint of prevention of recurrence of posterior uveitis at 6 months. In the 153-patient trial, 21.8% of Durasert-treated patients had a […]
Clearside Biomedical highlights interim data from retreatment trial
Clearside Biomedical (NSDQ:CLSD) touted preliminary data from a non-interventional and retrospective trial of patients who participated in the completed Phase II trial of CLS-TA for suprachoroidal administration. Clearside’s formulation of triamcinolone acetonide, in combination with intravitreally administered Eylea, was evaluated as a treatment for macular edema associated with retinal vein occlusion. Get the full story […]
Report: Valeant shopping sale of surgical eye biz
Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) is looking to sell its Bausch & Lomb division’s surgical product assets to Carl Zeiss Meditec (ETR:AFX), according to a Bloomberg report. The surgical eye assets could be worth approximately $2 billion, according to the report, with a possible agreement still weeks away. No final decisions have been made, and other interested […]
Glaucoma laser developer Belkin Laser raises $5m
Ophthalmological device developer Belkin Laser has closed a $5.3 million round of financing, according to a Globes Israel report. The funding round was comprised of $2.5 million from Zico Holdings and Rimonci Capital and $2.8 million (EU €2.5 million) in an EU grant as part of the GLAUrious Program, which was initiated by Belkin Laser […]
Lamellar Biomedical launches dry-eye trial
Lamellar Biomedical said today that the 1st patients were enrolled in its trial evaluating Lamelleye for the treatment of moderate to severe dry-eye disease. Lamelleye uses the Scotland-based company’s Lamellasome technology to mimic the actions of serous lamellar bodies and regulate interfaces between tissues and external environments. Get the full story at our sister site, […]