Swiss biotech Oculis has raised $21 million in a Series B round backed by investors including Novartis (NYSE:NVS) and Bay City Capital. The company is developing topical drugs for back-of-the-eye diseases, which are normally treated with painful injections directly into the eye. Get the full story at our sister site, Drug Delivery Business News.
Optical/Ophthalmic
Pixium Vision wins FDA nod for Prima sub-retinal implant study
Pixium Vision (EPA:PIX) said today it won FDA approval to launch a clinical feasibility trial of its Prima next-gen miniaturized wireless photovoltaic sub-retinal implant designed to treat patients with atrophic dry age-related macular degeneration. The trial of the device, which is slated to be conducted at the University of Pittsburgh Medical Center, aims ot recruit 5 patients […]
Mylan, Momenta take aim at Regeneron’s Eylea with biosimilar
Momenta Pharmaceuticals (NSDQ:MNTA) and Mylan (NSDQ:MYL) announced yesterday that they plan to launch a pivotal trial in the first half of 2018 for a proposed biosimilar to Regeneron‘s (NSDQ:REGN) blockbuster drug, Eylea. Eylea, a VEGF-inhibitor designed to treat wet age-related macular degeneration and diabetic macular edema, has little competition on today’s market. The drug brought in more than $5 […]
Glaukos seeks FDA IDE nod for iStent infinite trial
Glaukos (NYSE:GKOS) said today it submitted an investigational device exemption application to the FDA as it looks to launch a study of its iStent infinite trabecular micro-bypass system. The San Clemente, Calif.-based company’s iStent infinite is designed to reduce elevated intraocular pressure in patients with refractory glaucoma, and includes three heparin-coated titanium stents and an auto-injection […]
How this biotech plans to go up against big pharma with its eye disease products
Shankar Musunuri has spent time in both the pharmaceutical world and the biotech arena – after 15 years at Pfizer (NYSE:PFE), he went on to launch several biotech start-ups. As co-founder, chairman & chief executive of Ocugen, he is looking to bring eye disease products to the patients that big pharma’s drugs have left out. “There’s so much […]
Glaukos files PMA bid for iStent Inject glaucoma treatment
Glaukos (NYSE:GKOS) said today that it filed for pre-market approval from the FDA of its iStent Inject trabecular micro-bypass stent for treating glaucoma. San Clemente, Calif.-based Glaukos said the device is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It used a pair of heparin-coated titanium stents in a pre-loaded auto-injection system that allows […]
SEC subpoenas Ocular Therapeutix over pain relief implant
Ocular Therapeutix (NSDQ:OCUL) revealed last week that it received a subpoena from the Securities and Exchange Commission dated Dec. 15, requesting information about the company’s post-surgical pain relief implant, Dextenza, which was rejected by the FDA earlier this year. The Bedford, Mass.-based company did not specify what the SEC was asking for, but noted that the request covers […]
NovaBay shareholders clear $10m stock deal
NovaBay Pharmaceuticals (NYSE:NBY) said today that its shareholders have approved a deal to issue 2.4 million shares of common stock as part of a $10.3 million deal with Beijing-based Ch-gemstone Capital. The private placement is slated to close in January next year, contingent upon approval by regulatory authorities in China. Get the full story at our […]
TearLab cuts headcount in restructuring effort
TearLab Corp. (OTC:TEAR) is looking to keep its customer base and reduce the company’s cash burn rate with a new business model that will result in people losing their jobs, according to regulatory filings. The company said that it wants to focus resources on the development of its next-gen TearLab Discovery platform. Get the full story at […]
FDA rejects Santen’s intravitreal uveitis therapy
Shares in Santen Pharmaceutical (OTC:SNPHY) fell -3% today after the company’s U.S. subsidiary said that the FDA rejected the application for its intravitreal sirolimus therapy The company is developing its DE-109 product to treat people with noninfectious uveitis of the posterior segment, which can cause blindness in adults. Get the full story at our sister site, Drug […]
Aura Biosciences raises $30m for nanoparticle cancer treatment
Aura Biosciences has closed a $30 million Series C round with funding from new investors like Arix Bioscience and Lundbeckfonden Ventures, as well as existing investors, including the estate of former-Genzyme CEO Henri Termeer, who died earlier this year. The privately-held biotech is developing a light-activated nanoparticle therapy for patients with ocular melanoma. Aura said it […]