Eyenovia, a startup that has adapted an inkjet printing technique into a way to deliver drugs to the eye, is providing more clarity on an initial public offering intended to finance late-stage clinical testing of its technology.
New York-based Eyenovia plans to offer 2.73 million shares priced between $10 and $12 each, according to an updated prospectus filed with securities regulators. At the midpoint, the IPO would raise $30 million. The company has applied for a listing on the Nasdaq exchange under the stock symbol “EYEN.”
Eyenovia is trying to offer a better way for doctors and patients to administer tiny amounts of eye drugs than conventional eye droppers. Though the human eye holds between 6 and 8 microliters of fluid, eye droppers deliver as much as 50 microliters. That dosing overexposes the eye to a drug and its preservatives, which can lead to toxic effects, the company says in its filing. Eyenovia claims its technology, which delivers micro doses of already approved eye drugs, can reduce a patient’s exposure to a drug and its preservatives by more than 75 percent.
Piezo printing, a technique used in high-precision inkjet printing, is the basis for Eyenovia’s technology. The company says its device creates a micro jet that quickly and accurately delivers a dose to the surface of the eye’s cornea, where most drug penetration occurs.
Though Eyenovia’s technology is a medical device, the company doesn’t expect it to be reviewed or regulated like one. It says in the IPO filing that it has written feedback from the FDA stating that the product won’t be treated as a medical device, or even as a drug/device combination product.
“All of our programs are treated as drug development programs because only the drug comes into contact with the eye,” the company says in the prospectus.
Rather than securing the FDA’s O.K. for its device, Eyenovia says it will seek approval for its drug formulations, which have been developed to be administered in micro doses. The Eyenovia drugs will go through a pathway for modifications of already approved therapeutics, including new formulations. Eyenovia still needs to show evidence that its drugs are safe and effective, but it can use some data that was submitted in earlier applications, potentially saving time and money.
Eyenovia has two lead programs, one for glaucoma and the other for dilating pupils for eye exams. The company’s MicroProst product is a microformulation of … Next Page »