A Quick Review of Some Updates Delivered at OIS@ASCRS

OIS Co-Chairs Discuss Record-Breaking OIS@ASCRS

OIS co-chair Gil Kliman, MD, managing director of InterWest Partners, opened last week’s OIS@ASCRS with a rousing look at innovation in ophthalmology.

“I’ve never been more excited than I am right now for the amazing innovations that are happening throughout ophthalmology and in particularly in the anterior segment,” Kliman told the crowd of nearly 600. “When you look at the number of new things being introduced, commercialized, and changing the standard of care around the world, I don’t know that any of us have seen anything like this.”

We’ll be bringing you content from throughout the day in coming weeks. This week – in a separate email – we’ll deliver the backbone of OIS, the 21 presenting companies that opened the day with updates on their promising programs.

Below are a few new takeaways from several of the presenting companies.

Yari Mitchell, VP, global medical affairs and business strategy at AcuFocus, delivered a commercial overview and laid out some of the changes AcuFocus has made to its strategy.

A private study by Aerie Pharmaceuticals suggests that Rhopressa lowers intraocular pressure (IOP) equally during nocturnal and diurnal periods. The company points out that current glaucoma medications either have no or reduced efficacy at night. “If we can replicate this in a larger trial we may have another significant example for Rhopressa,” said Tom Mitro, chief operating officer. The company also unveiled its new marketing program.

Reza Zadno, president and CEO of Avedro, laid out Avedro’s story, including the high potential for its corneal-shaping PiXL technology that could be used to treat low myopia, presbyopia, hyperopia, and other conditions. He also hinted at the company’s new financing and its plans to pursue reimbursement.

Mark Packer, MD, chief medical officer at Cassini, told OIS@ASCRS the cornea measurement company is moving into the diagnosis of dry eye disease.

Paul McLean, CEO of ClarVista Medical, stressed the importance of rotational stability as he extolled the benefits of the company’s Harmoni Intraocular Lens (IOL). The firm expects to file an IDE for its Harmoni Modular IOL this year and begin its US clinical trial in 2018.

Stephen From, CEO of EyeGate Pharma, expects to deliver Phase IIb top-line data for EPG-547 for cataract surgery by the end of 2017, with an eye toward launching a Phase III trial in 2018 and filing an NDA by the second half of next year.

Russ Trenary, president and CEO of InnFocus, updated attendees on the progress of MicroShunt, which the company says could be the first and only surgical device/procedure to provide treatment for mild-, moderate-, and severe-stage primary open angle glaucoma. Santen acquired InnFocus in 2016.

Dave Van Meter, president and CEO of Ivantis, said the company is exploring new ways to leverage its Hydrus Microstent technologies including incorporating a 24-hour IOP monitor that would link to a smartphone. It has also initiated a project in drug delivery.

Mark Iwicki, chairman and CEO, said Kala Pharmaceuticals expects to have three Phase III trials (two for pain and inflammation, one for dye eye) completed this year and has eyes on filing two NDAs within the next nine months.

Chris Geddes, MD, chief biomedical/plasmonics consultant at LacriScience, previously introduced his company’s LacriPen as a method of measuring tear osmality. In this presentation, Dr. Geddes reviewed the technology’s broader diagnostic capabilities.

Mati Therapeutics expects to file an IND for Nepafenac this summer and has its sights on running a Phase II multicenter trial of patients undergoing cataract surgery, measuring both pain and inflammation. Mati has similar goals for Difluprednate.

John Hendrick, president and CEO of Mynosys Cellular Devices, reported strong progress for Zepto, a disposable capsulotomy device. The company completed US clinical trials and submitted a request for 510(k) notification in March. Hendrick also said a trial launch in Germany and India demonstrated strong demand for the product.

Ocular Therapeutix has a PDUFA date of July 19 for Dextenza. If approved the company anticipates launching the post-surgical pain product in the first half of 2018.

Gary Wörtz, MD, chief medical officer of Omega Opthalmics, allowed OIS attendees to see the first public implantation of his company’s Omega Gemini Refractive Capsule. The refractive implant improves vision but also maintains a space where future lenses could be implanted. The capsule would be used on cataract patients.

Board member Gerd Auffarth, MD, shared his unique perspective on Presbia’s Flexivue Microlens designed to eliminate the need for reading glasses.

Jim McCollum, co-founder and board member of Presbyopia Therapies, introduced LiquidVision, an eye drop regimen that might correct presbyopia. The drops would be administered daily, or as needed, with a duration of five hours or more.

Barry Cheskin, co-founder, president, and CEO of PowerVision, delivered early results on the release of FluidVision 2020 into the clinic. The company reports 24 successful surgeries to date.
Mike Judy, CEO, Refocus Group, a company dedicated to non-invasive surgical solutions for presbyopia, presented early data on its ongoing clinical trial. The firm hopes to secure FDA approval in early 2018.

Sarah Cannon, director of global marketing for ReVision Optics, updated OIS@ASCRS on the commercial launch of its Raindrop inlay for presbyopia. “We are going to be scaling up with Raindrop across the country,” she said.

Thomas Chalberg, founder and CEO, introduced SightGlass Vision to OIS. The company hopes to revolutionize myopia care. The firm is raising a Series A funding for pivotal study and a global launch.

Monty Montoya, president and CEO of Sightline Surgical, delivered many updates on the company’s new take on corneal care. The start-up is evaluating tissue, preparing tissue for transplant, and managing the transportation logistics. In addition to introducing new advisory board members and product offerings, Montoya announced a novel partnership with Dr. Shigeru Kinoshita of Kyoto to employ a new endothelial cell therapy in corneal treatment. The company expects to raise a $30 million Series B in 2018.