It’s been a rocky road for pSivida‘s (NSDQ:PSDV) Illuvien, a drug/device combination for diabetic macular edema, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.
Optical/Ophthalmic
Federal circuit defends InSite Vision’s win over San Francisco university
InSite Vision (OTC:INSV) eked out a narrow win against the University of California in San Francisco in a patent battle over eye treatment.
EyeTechCare raises $13M for ultrasound glaucoma treatment
EyeTechCare said it landed nearly $13 million in its 3rd round of funding, aiming to use the cash to fund a clinical trial of its EyeOP1 ultrasound glaucoma treatment, which has been on the market in Europe since
Rillieux-la-Pape, France-based EyeTechCare said the backers include private investor Dr. Bernard Chauvin and prior investors Omnes Capital and France’s SHAM insurance company.
Avedro lands $43M in Series D financing round
Medical device company Avedro finished up a $43 million Series D financing round this week with the help of a pair of new investors, venture capital shops Third Point and Abingworth.
To tie the knot, Avedro is bringing on 2 new board members from its latest backers, Abingworth’s David Maye and Jason Hong of Third Point.
Avedro’s products are used primarily in support of Lasik laser eye surgery. The company is currently wrapping up Phase III clinical trials. Currently, none of the company’s products are for sale in the U.S.
Alzheimer’s: Cognoptix’s eye exam aims for early detection
Massachusetts medical device maker Cognoptix launched a clinical trial of its Sapphire II eye exam, assessing its potential for diagnosing early stages of Alzheimer’s disease by detecting certain biomarkers in the eye.
The non-invasive exam looks for traces of beta amyloid peptides, a hallmark of Alzheimer’s disease which grows in parallel in the eye as well as in the brain, according to the company.
FDA to review Bausch + Lomb’s intraocular lens
Eye care giant Bausch + Lomb won a date with the FDA for review of its Trulign Toric intraocular lens for improving vision in patient who have undergone cataract surgery.
On April 8, 2012, the FDA’s Ophthalmic Devices Panel will review clinical data and cast a vote on the Trulign Toric implant in treatment of patients with vision impairment as a result of aphakia and postoperative refractive astigmatism.
Ocular Therapeutix submits PMA for ReSure ophthalmic sealant
There’s nothing left for Ocular Therapeutix to do but sit back and wait for the FDA to decide on the pre-market approval application for its ReSure ophthalmic sealant.
The Bedford, Mass.-based medical device company is hoping to be able to get the sealant on the U.S. market this year based on a 488-patient clinical trial, CEO Amar Sawhney said in prepared remarks.
No longer in the dark
By: William Maisel, M.D., M.P.H.
We take so much for granted.
That was my thought when I first heard about the Argus II Retinal Prosthesis System, a new device approved by the FDA today.
This small electronic device, implanted in the eye, may improve the visual function of patients with advanced retinitis pigmentosa, or RP.
FDA approves 1st “bionic eye” for the blind
California medical technology maker Second Sight Medical is the 1st to bring a "bionic eye" to the U.S. market, landing FDA approval for the Argus II retinal prosthesis for treatment of blindness.
Telemedicine brings expert blindness screenings to preemies
We’re in the Neonatal Intensive Care Unit at South Shore Hospital. Six tiny, swaddled preemies are ready to be examined, their eyes numbed and their pupils dilated with special drops.
Ivantis reels in $27M Series B round | Wall Street Beat
Ivantis said it raised a $27 million Series B round led by Ascension Health Ventures aimed at funding a quartet of clinical trials for its Hydrus Microstent glaucoma treatment.
The Irvine, Calif.-based medical device company said the device, an eyelash-sized stent, is designed to reduce eye pressure.
