Cornea | Ophthalmology Innovation Source

FDA Making the Rounds in Ophthalmology

Over the past week, news about the FDA has been flooding the inboxes of ophthalmology watchers. The most notable news came Shire plc. The regulatory agency requested that Shire conduct an additional clinical trial as part of a complete response letter for the company’s NDA for lifitegrast, a potential treatment for dry eye disease in…

Google Lens Clinical Trials to Start in 2016

Novartis, through its Alcon eye-care division, intends to start clinical trials of an accommodative Google “smart” contact lens in human eyes next year, Novartis Chief Executive Joe Jimenez told the Swiss French-language newspaper Le Temps last week. “This project is progressing well,” Jimenez told Le Temps reporter Willy Boder. “When we announced the agreement a…

Kala Therapeutics

By penetrating the mucosal barrier in the eye, Kala’s Mucosal Penetrating Products (MPPs) “enhances pharmacokinetics” and can be used to treat both anterior and posterior segment disorders. Top-line results from a Phase 3 clinical trial of KPI-121 (loteprednol) achieved all primary efficacy endpoints in the treatment of inflammation and pain post-cataract surgery. A phase 2/3…

LacriScience

The company’s LacriPen is a handheld, portable, diagnostic tool that measures osmolarity to within 2 mOsml. It uses a technique called surface plasma residence, which calculates minute changes in the refractive index on a very thin gold film. The reflectivity minimum line produces moves as a measure of osmolarity; when in use the device is…

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…

ReVision Optics

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…

Avedro CEO Muller Answers Questions About The FDA’s Questions

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 039″] David Muller, CEO of Avedro, addresses delays in the FDA’s review of the company’s riboflavin ophthalmic solution/KXL System for corneal cross-linking and discusses the considerable potential of PIXL. Podcast Guest David Muller, PhD Dr. Muller recognized the potential of using advanced methods to gently reshape the cornea and in 2007…

Lindstrom Wins Ophthalmology Innovator Award

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 038″] OIS Co-Chair Bill Link interviews Richard Lindstrom, MD, after awarding him with the Ophthalmology Innovator Award at OIS@ASCRS on April 16, in San Diego. Podcast Guests William J. Link, PhD Bill was Founder, Chairman and CEO of Chiron Vision, sold in 1997. Bill founded and served as President of American…

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…

PowerVision’s Cheskin Discusses The Potential Of The Company’s Accommodating IOL, FluidVision

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 035″] For 10 years PowerVision has been advancing its accommodating IOL, Flu-idVision. Co-Founder, CEO and President Barry Cheskin explains how the company has kept its focus on someday capturing a huge piece of the IOL market. Podcast Guest Barry Cheskin Barry Cheskin is Co-Founder, President & CEO of PowerVision. Mr. Cheskin…

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…

Talley Rostov Works To Improve Global Vision

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 030″] Seattle Ophthalmologist Audrey Talley Rostov explains how she became involved in an international movement to end corneal blindness.