Ocular Therapeutix, the latest endeavor of serial entrepreneur Amar Sawhney, released positive findings from a Phase II study of its absorbable intracanalicular plug, designed to provide long-term drug therapy following eye surgery.
Optical/Ophthalmic
UPDATE: FDA panel approves Ocular Therapeutix’ ReSeal, with reservations
An FDA advisory panel voted yesterday that Ocular Therapeutix’s ReSure topical hydrogel post-op sealant is safe, but split on questions of efficacy and whether the benefits of the treatment outweigh its risks.
The FDA’s Ophthalmic Devices Panel voted 9-1, with 1 abstention, that the ReSure sealant is safe; 5-3, with 3 abstentions, that it is effective; and 5-1, with 5 abstentions, that its benefits outweigh its risks.
FDA eye experts give mixed recommendation for post-op sealant
A panel of experts today voted that Ocular Therapeutix’s ReSure Sealant topical hydrogel post-op sealant is safe, but panelists were split on questions of efficacy and whether the benefits of the treatment outweigh the risks.
Mobile vision app is looking for a partner after raising $550k | MassDevice.com On Call
MASSDEVICE ON CALL — Texas mobile health startup Vital Art & Science is looking for a pharmaceutical industry partner now that it’s raised $550,000 in support of its MyVisionTrack iPhone hyperacuity test.
LensAR seeks $19.8M for laser cataract surgery systems
Orlando, Fla.-based LensAR has raised $2.3 million so far among 3 unnamed investors, hoping to hit $19.8 million in equity funding, according to documents filed with the SEC.
The fundraising round, launched at the start of the month, isn’t independent of any other business transaction, the company noted.
Second Sight tallies government funding for Argus II ‘bionic eye’
Swiss vision-treatment devices maker Second Sight Medical doubly touted Medicare reimbursement coverage for its Argus II retinal prosthesis, tallying coverage in 3 nations now as the "bionic eye" technology gains more ground.
Staar Surgical launches LASIK alternative in India
Staar Surgical (NSDQ:STAA) won regulatory approval from India’s Central Drugs Standard Control Organization for its LASIK eye surgery alternative, the Visian implantable collamer lens with CentraFlow.
Abbott closes OptiMedica buyout
Abbott (NYSE:ABT) said it closed the buyout of OptiMedica Corp. it announced in July, paying $250 million up front with another $150 million on the table if development, regulatory and sales milestones are met.
The buyout expands the Chicago-area healthcare giant’s Abbott Medical Optics ophthalmology unit by adding femtosecond laser-assisted cataract surgery to its portfolio.
Medicare approves coverage for Second Sight’s Argus II ‘bionic eye’
Second Sight Medical touted Medicare coverage for its Argus II "bionic eye" implant, a retinal prosthesis designed to help restore some vision to patients blinded by a rare disease.
The 1st-of-its-kind technology is comprised of 2 main components: an eyeglass-mounted camera and an electrical stimulator implanted in the eye. The device converts images captured by the camera into a series of electrical pulses that are transmitted wirelessly to electrodes in the retina to simulate vision.
Diabetes: Freedom Meditech lands $7M to support non-invasive eye-based exams
Freedom Meditech roped in $7 million in a Series B financing round in support of 2 diagnostic products for diabetes management, 1 already on the shelves and 1 still on the bench.
UPDATE: Ocular Therapeutix wins FDA panel date for ReSure sealant
UPDATED August 2, 2013, at 2:15 p.m. with comment from Ocular Therapeutix CEO Amar Sawhney
An FDA advisory panel is slated to convene Sept. 19 to review the pre-market approval application for Ocular Therapeutix Inc.’s ReSure sealant.
The FDA’s Ophthalmic Devices Panel will review the PMA for the ReSure product, a hydrogel designed to seal incisions to the cornea made during cataract or intraocular lens placement surgery.