Posts Tagged ‘Inlays’

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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AcuFocus Outlines Kamra Launch

The KAMRA small-aperture corneal inlay from AcuFocus was approved by the FDA in April 2015 for the treatment of presbyopia, and the company began a controlled commercial launch in June. Nicholas Tarantino, OD, chief clinical and regulatory officer of AcuFocus, said that the US rollout has exceeded every internal company metric. During the first year…

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ReVision Optics Eyes Panel Discussion in Q3

The Raindrop Near Vision Inlay for the treatment of presbyopia boasts a 2-mm diameter, 80% water composition, the same refractive index as the natural cornea, and is removable, said ReVision Optics’ president and CEO John Kilcoyne. “This is profocal shape-changing technology,” he said. “The Raindrop changes the anterior curvature of cornea to improve near and…

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Allotex

OIS@ASCRS - Companies to Watch - Allotex 2016

The driving force behind Allotex was the observation that the potential interest in synthetic corneal inlay technology was being dampened by the persistent biocompatibility issue. Recognizing the many technological changes that have occurred since Barraquer’s early pioneering epikeratophakia work, the company was established to develop human allograft inlays and onlays to satisfy a growing market…

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Muller Explains Departure from Avedro; Opportunity in New Venture

OIS-Podcast

David Muller came close to writing the final chapter of Avedro’s push to have corneal cross-linking approved by the FDA. But he opted to leave the company before the final approval came through to pursue a new venture called Allotex. In this interview with OIS Podcast, Muller explains his decision to leave Avedro and tells…

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Tarantino on How AcuFocus Found Success Rolling Out KAMRA

Tarantino on How AcuFocus Found Success Rolling Out KAMRA

Acufocus’ Nick Tarantino, Chief Global Clinical Research & Regulatory Affairs Officer, explains how AcuFocus is taking a “nice and measured” approach to rolling out its KAMRA inlay as a treatment for presbyopia. The KAMRA inlay received US approval on April 17, 2015, making it the first corneal inlay to achieve this landmark. Since approval, the…

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AcuFocus

AcuFocus

AcuFocus is committed “to continuously adapting and expanding” its small aperture technology. The company’s first device, the KAMRA, received US regulatory approval in April 2015, and the firm has begun a slow launch. In development is the IC-8 intraocular lens (IOL). To date, AcuFocus has “extensive clinical data” on about 200 patients. The IC-8 already…

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ReVision Optics

ReVision Optics

The presbyopia market is estimated to comprise more than 2 billion people by 2020. ReVision Optics has developed the Raindrop Near Vision inlay to address that market, with a potential of 30 million eligible patients. The Raindrop itself is a 2-mm diameter hydrogel inlay, 30 microns thick. It’s 80% water. It’s clear, so it enables…

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ReVision Optics

Revision Optics ASCRS 2015

The Raindrop Near Vision Inlay has had three of the four modules submitted for the IDE, and the fourth is expected to be submitted some time in Q3 2015. Barring any unforeseen issues, that should put it on track for an Ophthalmic Panel discussion some time in the H1 2016, with a likely approval in…

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AcuFocus

AcuFocus ASCRS 2015

Nick Tarantino, Chief Global Clinical Research & Regulatory Affairs Officer AcuFocus’ newest technology, the IC-8 small aperture IOL, builds on the company’s long-term experience with small aperture optics (it developed the KAMRA lens for presbyopia about 10 years ago). The IC-8 essentially takes the KAMRA inlay from the corneal plane to the lens plane. The…

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