FDA | Ophthalmology Innovation Source

Mazzo Details Plans For Kamra Inlay’s Introduction To The US Following FDA Approval

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 037″] Chairman and CEO Jim Mazzo tells how the AcuFocus team went above and beyond to share news of Kamra’s FDA approval at ASCRS, looks forward to US launch. Podcast Guest Jim Mazzo Jim Mazzo is the Executive Chairman and CEO for AcuFocus. AcuFocus specializes in presbyopia correction and is known…

CMS Opens Sunshine Act Review

Physicians have 45 days to review and dispute payments from industry. The Ophthalmology Innovation Summit opening on Thursday is clear evidence of the advances that can come with clinicians and industry working together. But such cooperation comes with oversight. The Centers for Medicare and Medicaid Services (CMS) has opened its Open Pay-ments system to allow…

Cross-linking platform denied FDA approval—for now

UPDATE 4/19/16: Avedro Finally Secures FDA Approval Read Full Story Click Here In late February, a joint panel of the Food and Drug Administration voted to recommend Avedro’s corneal cross-linking platform for regulatory approval. The combined riboflavin ophthalmic solutions and ultraviolet light irradiation for corneal collagen cross-linking platform may be approved for the treatment of…

Second Sight Fulfills Dream

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 022″] Second Sight President & CEO Robert Greenberg, MD, PhD looks back on Second Sight’s long road to getting FDA approval for Argus II and considers the path not taken. Podcast Guest Robert Greenberg, MD, PhD Dr. Greenberg currently serves as Chairman of the Board of Second Sight Medical Products. He…

Cunningham: 2015 Could Be A Big Year For Ophthalmology

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 020″] OIS Co-Chair Emmett Cunningham delivers a high altitude review of the much sought after “Year in Review” report he delivers at each event. In this review, Cunningham touched upon his hopes for the sector & OIS. Podcast Guest Emmett T. Cunningham Jr., MD, PhD, MPH Dr. Cunningham joined Clarus Ventures…

Alimera CEO Myers Shares Lessons From Iluvien FDA Approval

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 018″] The FDA turned away Alimera Sciences’ bid to market Iluvien as a treatment for diabetic macular edema three times before finally giving the green light. President & CEO Dan Myers shares what kept his confidence up during this lengthy review and how Alimera Sciences is positioning Iluvien in the DME…

FDA Q&A

Food and Drug Administration to adopt guidelines and standards to help expedite approvals. Two key players within the agency, Dr. Wiley Chambers and Dr. Malvina Eydelman, sat down for an open Q&A with Emmett Cunningham, MD, co-chair of OIS@AAO. Dr. Eydelman is director of the Division of Ophthalmic and Ear, Nose and Throat Devices, and…

Avedro

Avedro’s KXL® System for accelerated cross-linking, as well as a family of riboflavin products, have been commercially available since 2010. Refractive correction pioneer and veteran David Muller, PhD, President & CEO, discussed the company’s most recent activities, expressing excitement about Avedro’s PiXL, a non-invasive refractive correction procedure, which uses only eye drops and light. Among other…

PowerVision

PowerVision Inc.’s FluidVision, an intraocular lens designed to treat presbyopia and/or cataracts, is the only technology that restores true accommodation, reported company President and CEO Barry Cheskin at the OIS forum. It does so by efficiently harnessing the natural muscular forces of accommodation in the eye to move fluids inside the lens. That fluid movement…

Opening The Door For Premium IOLs

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 017″] OIS stalwart Jack Holladay, MD shares details on the work of a task force comprised of representatives from the American Academy of Ophthalmology and the Food and Drug Administration charged with updating the regulatory agency’s Grid and developing a Guidance Document for Extended Depth of Focus and Accommodating IOLs. The…

Eye Companies Helping Health Care Stand Out

Healthcare stocks are outperforming the indices, and ophthalmic companies are helping to fuel a large part of that growth, Jeffrey Hoffman, Managing Director and Head of West Coast Healthcare Investment Banking for J.P. Morgan, told attendees at the Ophthalmology Innovation Summit in Chicago. “Healthcare has outperformed most other sectors, and it has been primarily driven…

FDA Division Directors Detail How Agency Adapts to Innovation

The rush of innovation in ophthalmology – both in drugs and devices – is driving the Food and Drug Administration to adopt guidelines and standards to help expedite approvals. Two key players within the agency, Dr. Wiley Chambers and Dr. Malvina Eydelman, sat down for an open Q&A with Emmett Cunningham, MD, co-chair of OIS@AAO.…