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 illuminated spray hole on its face. The idea is to deliver only the therapeutically effective amount of drug to the eye without wastage, thus decreasing systemic absorption and associated side effects, Dr. LaBelle said.
The device is designed to solve the well-documented problems with eyedroppers: delivering too much drug overall and sometimes not getting enough drug into the eye. “The eye holds less than 10 microliters of an agent, but most drops are well above 50 microliters,” Dr. LaBelle said. “For therapies that have systemic side effects, that can actually lead to some problems for patients. We see that especially with glaucoma medications.”
The proprietary Eyenovia device uses piezo-electric technology that “prints” drugs onto the eye, Dr. LaBelle said. “It delivers micro-doses [under 10 microliters], only what is necessary,” he said. Additionally, the device puts a charge into the agent so it adheres to the cornea. Physicians can also download compliance data onto an electronic health record.
“Our strategy is to take existing drugs that may have less than ideal side-effect profiles and enable them to be delivered through this micro-therapeutic approach,” Dr. LaBelle said. “We think there’s a real advantage for combination therapies in particular.”
Dr. LaBelle explained that the FDA has not approved fixed-dose combination drugs unless they have shown efficacy or safety improvements over delivering drugs separately. He said this approach could improve safety profiles and enable FDA approval of combination therapies that have been unable to enter the US market.
He said the cost would be competitive – slightly more for existing generic drugs but less expensive for combinations.
Eyenovia plans to submit an Investigational New Drug application to the FDA this summer for short endpoint phenylephrine studies and is planning late-stage glaucoma studies for 2017, Dr. LaBelle said. The company hopes to bring the phenylephrine and glaucoma therapies to market in 2019.
In an audience response poll, 60% said the platform is best suited for glaucoma drugs, 27% said dry eye agents, and 13% said allergy therapies. In a separate poll, 63% said Eyenovia’s future is bright.
Curt LaBelle, MD
Dr. LaBelle has been actively involved in the healthcare industry for 16 years, both operationally and as an investor.