OIS Co-Chair Emmett T. Cunningham Jr., MD, PhD, MPH laid out hopeful – and cautionary – signs facing the ophthalmology industry as he kicked off last week’s OIS@AAO with his comprehensive Year in Review presentation.
Speaking before more than 900 people gathered at the Hyatt Regency Chicago, Cunningham reviewed the industry’s successes with the FDA, including the approvals secured by big players – Shire and Allergan – as well as smaller companies like Avedro and ReVision.
He also laid out the clinical trials to watch in the coming months, a list that headlined Aerie Pharmaceuticals and Ophthotech.
To watch the presentation yourself, please click here or see the “Watch Video” button on your Eye on Innovation Newsletter.
For those interested in obtaining a copy of Cunningham’s expanded Year in Review presentation, which will include slides not presented at the conference, watch for details in upcoming Eye on Innovation Newsletters. We’ll present an easy opportunity for you to download the presentation.
Here is some other news and observations picked up by our editorial staff throughout the day.
Reporter’s Notebook Contributions for OIS@AAO 2016
Sue Washer, president and CEO of AGTC, which is developing gene therapies to treat inherited orphan diseases of the retina, advises that ophthalmic innovators need to think about the longer-term beyond regulatory approval. “There are endpoints that you look at for regulatory approval, but you want to be thinking about what are the datasets you will need to convince the insurance companies to provide reimbursement, and that might be a whole different set of issues,” she told the Breakfast Breakout on gene and stem cell therapies at OIS@AAO 2016. – Richard Mark Kirkner
Bernhard Gunther, CEO of Novaliq GmbH, sported an easy smile during an interview with OIS-TV. “We will have a new CEO on November 1,” Gunther announced. “I will change to the role of chief innovation officer, and I am very happy as a co-founder that I will still be on board.” Gunther said new CEO Christian Roesky, PhD, brings an “enormous background in ophthalmology” that will carry the drug delivery company to its next level. – Tom Salemi
In two years the American Academy of Ophthalmology’s IRIS registry – for Intelligent Research in Sight – has become the largest specialty clinical data registry in the world with more than 100 million visits, AAO CEO David Parke II, MD, reported. The database includes 3.7 million cataract operations and 4.5 million intravitreal injections for retinal disease. For ophthalmologists, IRIS has resulted in savings of $255.5 million to $328.5 million in 2015 alone. “For industry, this is a tremendous way to measure value, new knowledge generation, and basically mining this fantastically rich database in everything from rare diseases to natural history to treatment impacts,” Dr. Parke said. – Richard Mark Kirkner
Bill Burns, CEO of Encore Vision, is gearing up for Phase IIb trails of its EV06 ophthalmic solution 1.5%. EV06 is a novel topical therapy that targets presbyopia by restoring crystalline lens flexibility, thereby allowing the lens to focus on nearby objects. Encore hopes to be lining up a pivotal Phase III for 2018. – Tom Salemi
The National Eye Institute of the National Institutes of Health has an active intramural translational research program that includes a project in induced pluripotent stem cell (IPSC) and ocular gene therapy, said Mala Dutta, PhD, lead, office of translational research at NEI. Researchers have developed a way to convert skin and drug fibroblasts to IPSCs and then to retinal pigment epithelium cells. “They are on track for human trials in two to three years,” Dr. Dutta said. “This is the leading stem cell program at NIH for neurotransplantation.” – Richard Mark Kirkner
The market acceptance of corneal inlays, tiny devices inserted into the cornea to treat presbyopia, has been disappointing to date. At OIS@AAO, AcuFocus disclosed that it has sold only 30,000 Kamra inlays since commercial launch nearly a decade ago. So, what’s new here? AcuFocus just received $66 million of new capital from legendary private equity firm Kohlberg Kravis & Roberts. This huge infusion should significantly accelerate its sales and marketing efforts. – Larry Haimovitch
Joseph Boorady, president and CEO of TearScience, says a recently published paper reported that reported a single LipiFlow treatment reduced symptoms by 50%. Boorady told OIS-TV that TearScience had an extremely successful ASCRS where it sold more devices than it had in all of 2015. – Tom Salemi
The next steps for Sensimed’s Triggerfish contact lens is to expand its labeling to strengthen its utility claims and to gain reimbursement, CEO David Bailey told OIS@AAO 2016. Triggerfish is worn on the eye for 24 hours to provide continuous data on changes in intraocular pressure and other “ocular dimensional changes” that are important metrics in managing glaucoma. The company is also developing ocular volume change as a new biomarker to predict the course of glaucoma, Bailey said. – Richard Mark Kirkner
On June 29, ReVision Optics attained FDA approval for its Raindrop inlay without the expected FDA panel. “The good news is we’re nine months ahead of schedule,” CEO and President John Kilcoyne told OIS-TV. “The bad news is we’re nine months ahead of schedule.” Kilcoyne said ReVision worked furiously to get up to speed, hiring 12 sales reps. Stephen Slade, MD, who kicked off the company’s IDE study, performed the first commercial procedure on August 30. Next stop for ReVision? “We’re hiring clinical outcome specialists for every sales rep because we believe outcomes are very important to the success of the product. We need to lay a strong foundation to build on.” – Tom Salemi
Presbia has completed its US pivotal trial and expects to file a PMA in the second half of 2017. – Richard Mark Kirkner