Second Sight Medical (NSDQ:EYES) said today it won FDA investigational device exemption to initiate a feasibility clinical study of its Orion cortical visual prosthesis system. The conditional approval gives the Sylmar, Calif.-based company clearance to enroll up to 5 patients at 2 US sites, but requires that the company conduct additional device testing and “address outstanding […]
Optical/Ophthalmic
Carl Zeiss acquires cataract surgery planning software dev Veracity Innovations
Carl Zeiss Meditec (ETR:AFX) said today it is acquiring cloud-based ophthalmological tech developer Veracity Innovations for an undisclosed amount. Veracity Innovations developed and produces a cloud-based surgical planning platform for cataract surgeries, covering initial planning, management and analysis of the procedures. The system is designed to interface directly with multiple electronic medical records and diagnostic devices, […]
Opthea touts data from wet-AMD trial
Opthea (ASX:OPT) touted additional data today from the Phase I/IIa trial of its wet age-related macular degeneration therapy, OPT-302. The 50-patient Phase I/IIa trial recruited participants who were either treatment-naive or previously treated with an intravitreal anti-VEGF therapy. Researchers evaluated OPT-302 as a monotherapy and in combination with Lucentis (ranibizumab). Get the full story at our […]
BioTime lands $2m for dry-AMD therapy
BioTime Inc. (NYSE:BTX) said today that its subsidiary, Cell Cure Neurosciences, has landed a $2 million grant from the Israel Innovation Authority for the development of its dry-AMD therapy, OpRegen. The Alameda, Calif.-based company’s OpRegen is an investigational therapy that delivers retinal pigment epithelial cells into the subretinal space to replace lost RPE cells. Get the […]
Ophthotech eye-drug trial fails to meet primary endpoint
Shares in Ophthotech (NSDQ:OPHT) dipped to $2.46 apiece this morning after the company announced that its Phase III wet age-related macular degeneration trial failed to meet its primary endpoint. The New York-based company said that the addition of Fovista (pegpleranib) to Eylea or Avastin, both anti-VEGF therapies, did not significantly improve visual acuity after 12-months compared to […]
Ocular’s new CEO to ‘aggressively’ seek partnerships
Since the start of June, Ocular Therapeutix‘s (NSDQ:OCUL) stock price has fallen more than -45%. The company’s founder and chief executive, Amar Swahney, has stepped down, assuming the role of executive chairman, and the FDA has rejected Ocular’s resubmitted new drug application for its hydrogel plug, Dextenza. Amidst regulatory troubles, Ocular tapped former Mundipharma exec Antony Mattessich to serve […]
Clearside Biomedical misses EPS estimate in Q2
Shares in Clearside Biomedical (NSDQ:CLSD) fell slightly today after the biopharmaceutical company missed earnings expectations on Wall Street with its second quarter results. The Alpharetta, Ga.-based company posted a net loss of -$13.8 million on sales of $130,000 for the 3 months ended June 30, for bottom-line loss of -169% compared with the same period last year. Get […]
Allegro’s diabetic macular edema trial meets primary endpoint
Privately-held biotech Allegro Ophthalmics said today that its Del Mar Phase IIb stage 2 trial met its primary endpoint. The study assessed Luminate as a sequential therapy or combo therapy in 80 patients with diabetic macular edema. The San Juan Capistrano, Calif.-based company’s Luminate integrin peptide therapy treats neovascular retinal diseases by targeting integrin receptors, which are […]
Aerie’s contract manufacturer faces regulatory hurdle
Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates. The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA […]
Optovue wins FDA nod for optical epithelial thickness mapping system
Ophthalmological-focused developer Optovue said today it won FDA clearance for its epithelial thickness mapping software designed for quantitative measurements of the epithelial and stromal layers of the cornea. The Fremont, Calif.-based company touted it as the 1st and only FDA-cleared product which provides corneal epithelia and stromal measurements meant to aid in diagnosis of ocular health […]
J&J Vision to acquire TearScience
Johnson & Johnson‘s (NYSE:JNJ) Vision business said last week that it inked a deal to acquire ophthalmological medical device maker TearScience for an undisclosed amount. Resarch Triangle Park, N.C.-based TearScience produces devices focused on treating meibomian gland dysfunction, a leading underlying cause of dry eye disease, Johnson & Johnson said. TearScience has won FDA clearance […]