Researchers from the University of Southern California’s Roski Eye Institute developed a micropump that can be implanted directly into the eye and deliver a predetermined dose of the diabetic macular edema drug ranibizumab. Current treatments for glaucoma are traditionally delivered using eye drops. But studies show that some patients stop taking their prescription glaucoma eye […]
Optical/Ophthalmic
Aerie resubmits NDA for Rhopressa eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it resubmit a New Drug Application for the company’s Rhopressa eye drops. The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection. Aerie’s Rhopressa eye drops specifically target the eye’s trabecular network – the diseased tissue responsible for […]
TearLab readies for reverse split
Shares in TearLab Corp. (NSDQ:TEAR) said last week that its board approved a 1-for-1o reverse split of its common stock. The company’s shares have fallen nearly 20% since the beginning of the month. The San Diego, Calif.-based company’s move reduced the total number of authorized shares of its common stock from 95 million t0 9.5 […]
Clearside bails on AMD, all-in on diabetic macular edema
Clearside Biomedical (NSDQ:CLSD) said today it will redirect its R&D efforts from its pre-clinical axitinib wet age-related macular degeneration therapy to its Zuprata diabetic macular edema treatment. The Alpharetta, Ga.-based company said that recent trial results from other companies investigating combination therapies for wet AMD have led Clearside to reconsider its proprietary suspension formulation of […]
Alimera, Knight seek Canadian regulatory nod for Iluvien intravitreal implant
Alimera Sciences (NSDQ:ALIM) and Knight Therapeutics (TSE:GUD) said today that Health Canada accepted the companies’ New Drug Application for its intravitreal implant, Iluvien. The FDA approved Atlanta-based Alimera’s sustained release intravitreal implant in 2014 to treat diabetic macular edema in patients who have been previously treated with corticosteroids and did not have a clinically significant rise in […]
FDA accepts Ocular’s NDA resubmission for Dextenza
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 […]
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 […]