FDA | Ophthalmology Innovation Source

Ocular Therapeutix Waiting for Word from FDA

Ocular Therapeutix expects to hear from the FDA on its PDUFA date of July 24, 2016, on its new drug application for DEXTENZA, its sustained-release dexamethasone intracanalicular depot drug product candidate for treatment of postoperative pain, President and CEO Amar Sawhney, PhD, told the audience at OIS@ASCRS during the Ophthalmology Innovation Showcase. DEXTENZA would be…

Aerie Looks for Rhopressa NDA in Q3

Aerie Pharmaceuticals has completed all patient visits in two Phase III clinical trials of the Rho kinase inhibitor Rhopressa (netarsudil) 0.02% for treatment of glaucoma and expects to file a New Drug Application with the FDA in the third quarter of this year, president and COO Tom Mitro reported at OIS@ASCRS 2016. Rhopressa lowers intraocular…

TearLab Targets Multiple Biomarkers in Dry Eye

A physiologically stable ocular surface is a big determinant in cataract and refractive surgery outcomes, so TearLab Corp. is looking to build out its lab-on-a-chip platform to evaluate the ocular surface for additional biomarkers, CEO Seph Jensen told the panel on diagnostics and the premium channel at OIS@ASCRS 2016. The TearLab Osmolarity Test, for diagnosing…

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…

Refocus VIS Requires No Compromise

Refocus Group’s goal, according to CEO Mike Judy, is to become the preferred surgical alternative for the treatment of presbyopia. The VisAbility Implant System (VIS) is a “simplified procedure that delivers secure, uncomplicated, and consistent placement of the scleral implants,” he said. “This platform offers the only presbyopic solution that provides a full range of…

Device for Profoundly Blind Uses Tongue Electrodes

The profoundly blind form mental images of their surroundings from a variety of stimuli – touch, echo location, the their tip of cane or guide dog – and Wicab Inc. has developed a device that relays visual information via a neuro-stimulating array on the tongue to round out those images. Wicab president and CEO Robert…

How Eyenovia Aims to Solve the Problem of Eyedroppers

The natural solution to the problems associated with delivering drops to the front of the eye is inkjet printing, Eyenovia director Curt LaBelle, MD, told the “What’s the Future?” session at OIS@ASCRS 2016 in describing his company’s proprietary drug delivery device. The device looks like a small, white upright torpedo with a button and an…

PowerVision Shows `True Accommodation’

PowerVision has developed a fluid-controlled accommodating intraocular lens (IOL), the FluidVision AIOL, as the first platform to provide “true accommodation” by mimicking the eye’s natural accommodative process to transport fluids inside it, creating true shape change. “This is the first true shape-changing IOL system,” president, CEO, and co-founder Barry Cheskin said, and 36-month results are…

InnFocus’ Trenary Discusses New Funding, Timeline

To watch InnFocus’ OIS Companies to Watch Presentaion Click Here InnFocus CEO Russ Trenary participated in our Glaucoma section of OIS@ASCRS. We caught up with him in the hallways to discuss his company’s success. He’s also been a guest on our OIS Podcast. Video Highlights: 00:30 – How much did InnFocus raise and who were…

Sun Ophthalmics Looks to Build a Brand-New Business in the US

Sun Pharma, the fifth largest pharma company in the US, targeted ophthalmology as one of the first planks in its new branded pharma business. Hear ophthalmology veteran Jerry St. Peter explain how Sun Ophthalmics hopes to build a new team in ophthalmology. Ten Top Topics in this OIS Podcast: What are the origins of Sun…

Iridex Makes its Move in Glaucoma

Over the past couple of years, there has been no shortage of positive news about the glaucoma space. While minimally invasive glaucoma surgery (MIGS) has totally captured the limelight, Iridex Corp. has quietly begun to build momentum with its Cyclo G6 laser. Iridex has a more than 30-year track record in laser photocoagulation and a…

Avedro Finally Secures FDA Approval

On Monday, Avedro Inc. announced the US Food and Drug Administration finally gave a green light for its KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus. This is a story we’ve been following at OIS.net. According to the company, keratoconus is a progressive thinning and distortion of the cornea. It is…