Ocular Therapeutix (NSDQ:OCUL) said today that the FDA rejected its resubmission of a new drug application for Dextenza. This is the second time that Ocular has received the FDA’s dreaded complete response letter for Dextenza. In July last year, the FDA denied approval for Ocular’s hydrogel plug after it discovered ‘deficiencies in manufacturing process and controls’ in a pre-new drug […]
Optical/Ophthalmic
pSivida licenses European rights for Durasert to Alimera
pSivida (NSDQ:PSDV) said today that it restructured a deal with Alimera Sciences (NSDQ:ALIM) to grant Alimera rights to the Durasert three-year treatment for posterior segment uveitis in Europe, the Middle East and Africa. Alimera, which holds an exclusive license to pSivida’s intravitreal implant, Iluvien, plans to apply for a secondary indication for Iluvien for posterior segment uveitis. Get […]
Ocular seeks to extend regulatory timeline for Dextenza due to manufacturing concerns
Ocular Therapeutix (NSDQ:OCUL) said today that it submitted details of a manufacturing equipment change as an amendment to the new drug application resubmission for Dextenza, the company’s dexamethasone insert that is currently under review by the FDA. The FDA is slated to make a decision about the product’s regulatory approval by July 19. But the company recently […]
Inotek recalibrates after drug fails in glaucoma trial
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 […]
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 […]