Shares in Clearside Biomedical (NSDQ:CLSD) fell slightly today after the company missed expectations on Wall Street with its third quarter results. The Alpharetta, Ga.-based company posted a net loss of -$18.3 million for the 3 months ended Sept. 30, for bottom-line loss of -226% compared with the same period last year. Get the full story at our […]
Optical/Ophthalmic
FDA puts Second Sight Medical’s next-gen Orion ‘bionic eye’ on the fast track
Second Sight Medical (NSDQ:EYES) said today that the FDA put its Orion “bionic eye” on the fast track to approval. The Orion device is a cortical visual prosthesis that uses a camera and a brain implant to bypass the optic nerve in visually impaired patients. The federal safety watchdog put the device on its expedited […]
LumiThera touts interim data from pilot study of LT-300 AMD treatment
LumiThera today announced topline interim results from the Lightsite 1 trial of its LT-300 photobiomodulation device designed to treat dry age-related macular degeneration, touting statistically significant vision benefits maintained to 3 months. Data came from the 30-patient pilot study of the device, funded by a Small Business Innovation Research grant from the National Institute of Health […]
Eye-focused dev Tear Film Innovations closes $9m Series A
Eye-care focused device developer Tear Film Innovations said today it closed a $9 million Series A preferred stock round to support its iLux system designed to treat blocked meibomian glands in eyelids. The round was led by Visionary Ventures Fund and Tigris Ventures, the San Diego, Calif.-based company said. “There is no question the prevalence […]
Second Sight wins full FDA clearance for Orion cortical prosthesis feasibility trial
Second Sight Medical (NSDQ:EYES) said today it won FDA approval to launch a feasibility clinical study of its Orion cortical visual prosthesis system. With the approval, the Sylmar, Calif.-based company is cleared to enroll up to 5 patients total at the University of California at Los Angeles and Houston’s Baylor College of Medicine. The company said […]
Novaliq’s NovaTears dry eye disease therapy launches in New Zealand
Novaliq today launched its dry eye disease therapy, NovaTears, in New Zealand and said that it won registrational approval in Australia. The Germany-based company inked an exclusive licensing partnership earlier this year with AFT Pharmaceuticals (ASX:AFP) to commercialize Novaliq’s water-free topical eye drops in Australia. Get the full story at our sister site, Drug Delivery Business News.
Allergan’s intravitreal implant wins approval in China
Allergan (NYSE:AGN) said today that it landed an imported drugs license from the Chinese FDA to market its dexamethasone intravitreal implant, Ozurdex, as a treatment for adults with macular edema following branch retinal vein occlusion or central retinal vein occlusion. The Dublin-based pharma giant touted its therapy as the first intravitreal injection approved for RVO in […]
Pixium Vision wins French approval for Prima sub-retinal implant study
Pixium Vision (EPA:PIX) said today it won approval from France’s regulatory agency to launch a feasibility clinical study of its next-gen Prima sub-retinal implant in patients with advanced dry age-related macular degeneration. The Prima system is a next-gen wireless implant with a micro photovoltaic chip designed to be implanted under the retina to convert pulsed near-infra-red invisible […]
Second Sight wins go-ahead for German Argus II study in better-sighted RP patients
Second Sight Medical (NSDQ:EYES) said today it won approval from Germany’s BfArM regulatory body to initiate a 10-patient study exploring the use of its Argus II retinal prosthesis system in better sighted retinitis pigmentosa patients and individuals with tunnel vision. The Argus II induces visual perception in patients with retinitis pigmentosa by stimulating of the retina’s […]
Texas judge rules Allergan’s Restasis patents invalid
U.S. judge William Bryson ruled that patents covering Allergan‘s (NYSE:AGN) Restasis medicine are invalid on the grounds of obviousness, driving the company’s shares down more than -6% in afternoon trading today. The decision, made in a Texas federal court, is part of an ongoing case between Allergan and generic drugmakers like Mylan (NSDQ:MYL) and Teva Pharmaceuticals (NYSE:TEVA). Get the full story […]
FDA advisory committee backs Aerie’s Rhopressa eye drug
An FDA advisory committee voted today in favor of Aerie Pharmaceuticals‘ (NSDQ:AERI) Rhopressa product candidate. The dermatologic and ophthalmic drugs advisory committee voted unanimously that clinical trials support the efficacy of Aerie’s netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nine members of the committee voted to say […]