Is Surprising Raindrop Approval a Sign of Friendlier FDA?

One of the takeaways that ophthalmic innovators might be reading into the unexpected and somewhat sudden approval of the Raindrop Near Vision Inlay is that the FDA may be becoming more responsive and industry friendly. But that wouldn’t be the only takeaway. The FDA surprised virtually everyone in the ophthalmic surgical community June 29 when…

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Avedro Plots Future of Corneal Cross-Linking

Just about two weeks after getting Food and Drug Administration (FDA) clearance for its corneal crosslinking platform, Avedro Chief Medical Officer Rajesh K. Raipal, MD, outlined the company’s next steps to advance its position in the crosslinking space during the Ophthalmology Innovations Showcase at OIS@ASCRS 2016. The FDA approved three components of the crosslinking platform:…

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Heidelberg Makes Move into Cataract-Refractive Field

Heidelberg Engineering, which has more than 10,000 optical coherence tomography (OCT) units in place worldwide, is looking to help drive the premium channel by entering the cataract-refractive field with swept-source OCT imaging, Managing Director Kester Nahen, PhD, reported at OIS@ASCRS 2016. Heidelberg Engineering previewed its cataract and refractive imaging platform last year at the European…

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ClarVista Medical HARMONI Offers “Elegant Simplicity”

ClarVista Medical is a clinical-stage ophthalmic company that is introducing the HARMONI Modular IOL system to help surgeons navigate “the increasingly demanding environment of cataract surgery,” CEO Paul McLean said. Intraocular lens (IOL) design has not undergone a fundamental change in decades, but that’s about to change, he promised. “Until we can solve the dilemma…

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Thompson Sees Huge Influx of New Refractive Tech

Vance Thompson, MD is an internationally recognized specialist in Laser Vision Correction and Advanced Cataract Surgery. As a leading international researcher he has played a key role in the development of the most advanced technologies and techniques for both laser and implant vision correction. Dr. Thompson led our Refractive Correction – Corneal & Intraocular Breakfast…

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The OIS Lifetime Innovator Award goes to…

Roger Steinert, MD     For A Lifetime of Exceptional Contributions to Ophthalmic Innovation and Entrepreneurship Dr. Steinert’s advanced skill and excellent surgical results have earned him a reputation as an international consultant and leader in cataract surgery, refractive surgery and corneal transplants. He has conducted numerous, high-profile research studies and remains at the forefront…

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OIS Innovation Award Presentation

This video honors Tom Frinzi and Dan Durrie, MD, for their successful leadership at WaveTec. Recipients: Tom Frinzi Thomas Frinzi is Senior Vice President of Abbott’s vision business, which includes a broad ophthalmology portfolio across the areas of cataracts, refractive surgery (LASIK) and eye health products. Prior to joining Abbott, Mr. Frinzi held a number…

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Avedro

Avedro has submitted its New Drug Application for its riboflavin ophthalmic solution/KXL System (corneal cross-linking for the treatment of keratoconus and corneal ectasia following refractive surgery), and has a PDUFA date of April 16. In February 2015, the company presented to the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the…

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ClarVista Medical

ClarVista is a privately held, clinical- and commercial-stage ophthalmology device company concentrating solely on the development of the Harmoni modular intraocular lens (IOL) system. While surgical instrumentation and biometry devices have rapidly progressed and improved in the past decade, the fundamental design of the IOL has not. Surgeons (and patients) have, therefore, come to tolerate…

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Avedro

An ophthalmic panel voted to approve Avedro’s collagen crosslinking device for keratoconus and ectasia, but the FDA did not approve the device. The Complete Response Letter involved only the device, and not the clinical aspects of the trial, and Avedro executives remain confident these last hurdles will be easily overcome. The company is also working…

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Clearsight Innovations

Historically, IOL power formulations are good for average refractive outcomes, but poor for predicting an individual’s refractive outcome. The Mirricon may overcome those issues. The ocular biometer for high-performance IOL power calculations provides “results at the push of a button assuring convenience and easy decisions without great expertise and experience,” Mrochen said. An ongoing proof…

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Emmetrope

Emmetrope is developing 3 versions of an accommodating lens: single optic ActaLens, dual optic ActaLens-Duo, and shape-changing optic ActaLens-SC, “the future of accommodative lens technology,” said Phillips. To date, small numbers have been enrolled (n=8), but data looks promising—the monofocal hinged silicone ActaLens is injected into the capsular bag through a small corneal incision and…

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