Eyenovia has filed to raise up to $35 million in an IPO. The financing will support late-phase trials of candidates based on Eyenovia’s device, which uses inkjet printing technology to deliver small doses of drug to the eye.
New York-based Eyenovia has designed the device to reduce the adverse events associated with treating eye diseases. Eyenovia thinks some of these adverse events stem from the use of 30 to 50 µL eye droppers that deliver too much drug to the eye. The startup’s answer is a device that delivers 6 to 8 µL, a dose more in line with the fluid-holding capacity of the eye.
The piezo-print technology behind these microdoses is used in inkjet printing. In Eyenovia’s hands, it has become a means of delivering smaller doses of drugs to the eye than is possible today. The drug is held in one-month dose disposable cartridges. This component includes the piezo-driven ejector nozzle.
Eyenovia has housed the electronics that enable the delivery of doses from the cartridge in the permanent base part of the device. This component also features Bluetooth connectivity, enabling the device to send a message when the patient takes their medicine. This feature positions Eyenovia to provide the sort of compliance-tracking capabilities Propeller Health and Proteus Digital Health are bringing to inhaled and oral products, respectively.
If successful, the IPO will equip Eyenovia, a company with seven employees, to run pivotal trials of two candidates based on its device. In one product, MicroProst, the device is used to deliver latanoprost to the eyes of patients with chronic angle closure glaucoma. The other product, MicroStat, is designed to dilate the eyes of people who are undergoing ophthalmic examinations.
Eyenovia has phase 2 data on both candidates and now plans to run phase 3 trials that tee it up to file for FDA approval. The plan is to follow the 505(b)(2) pathway. As only the previously-approved drug comes into contact with the eye, Eyenovia thinks this is the only regulatory bar it will need to clear. The device won’t need approving separately.
The firm is heading toward commercialization with a legal case hanging over it. Eyenovia emerged in 2014 when it bought the assets of Corinthian Opthalmic.
Eyenovia’s CEO Tsontcho Ianchulev, M.D., and two of its board members, including PPD founder Fred Eshelman, were involved with both companies and now find themselves on the receiving end of a legal challenge. A Corinthian shareholder is alleging a fraudulent transfer and attempting to recoup about $1.1 million. Eyenovia doesn’t expect to suffer a material loss as a result of the case.