Kala Pharmaceuticals (NSDQ:KALA) today priced its initial public offering of 6 million shares of common stock at $15.00 apiece. The IPO is slated to bring in nearly $90 million for the Waltham, Mass.-based company. The offering, which is expected to close on July 25, includes a 30-day option for underwriters to buy up to 900,000 additional shares […]
Optical/Ophthalmic
Clearside Biomedical launches Phase II diabetic macular edema trial
Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the first patient in a Phase II clinical trial of CLS-TA in patients with diabetic macular edema. The trial plans to evaluate Clearside’s suspension formulation of a corticosteroid, triamcinolone acetonide, as a suprachoroidal injection in combination with an intravitreal injection of Eylea, an anti-VEGF agent. Patients with DME will either receive […]
FDA rejects Ocular’s Dextenza for a second time
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 […]
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. […]
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 […]
Icon Bioscience touts FDA NDA submission for Dexycu
Icon Bioscience said today that the FDA accepted the company’s submitted new drug application for its Dexycu drug designed to be used as an anti-inflammatory following cataract surgery. The Newark, Calif.-based company’s Dexycu utilizes the company’s Verisome novel drug delivery system designed to treat ophthalmic diseases and slowly release the drug while the Verisome system […]
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. The trials showed […]