No more eye drops: Eyenovia nabs FDA approval for pupil dilation spray Mydcombi

For patients preparing for an eye check, a newly FDA-approved spray could save the discomfort of receiving pupil-dilating eye drops.

Eyenovia has won FDA approval for Mydcombi, a fixed-dose combination of the two popular dilating meds tropicamide and phenylephrine, to induce mydriasis, the New York company said Monday.

Mydcombi marks the first product made with Eyenovia’s Optejet device system to be approved. Unlike traditional eye droppers where patients need to tilt their heads and fight the urge to avoid a droplet, Optejet dispenses its drug in microdoses horizontally as a spray with the push of a button.

By Eyenovia’s estimate, Mydcombi can target a dilation market of 108 million cases in the U.S. each year, including 104 million as preparation for eye exams and 4 million for surgeries. Those procedures together translate into a $250 million market.

Besides a more comfortable application, Mydcombi’s microdose technology could also avoid overdosing and reduce exposure to preservatives. The Optejet dispenser is designed to administer about a fifth of the volume of a traditional eye drop, just enough for the human eye to hold to avoid spillover.

Eyenovia has said Mydcombi will be pricier than existing eye drops, but it offers improved administration efficiency for doctors and a better patient experience.

Eyenovia plans to introduce Mydcombi to key eye doctors’ offices beginning this summer and will bring its internal manufacturing capabilities online for 2024, CEO Michael Rowe said in a Monday statement. The company will share more during its planned first-quarter report on Thursday.

Monday’s approval didn’t come easily for Eyenovia. Following a legal battle, the FDA in 2021 reclassified eye drug dispensers and droppers like Eyenovia as drug-device combinations. The reclassification led to a rejection for Mydcombi in October 2021 as the FDA said it would need additional device testing data.

The additional device data that Eyenovia used for Mydcombi could also come in handy for the company’s future filings for its other Optejet-based products.

One near-term project in Eyenovia’s pipeline is presbyopia candidate MicroLine. By Eyenovia’s estimate, age-related farsightedness represents a market of about $900 million annually in the U.S.

MicroLine is a pilocarpine formulation delivered using Optejet to temporarily improve near vision. Eyenovia has finished two phase 3 studies.

During Eyenovia’s fourth-quarter earnings call on March 30, Rowe said the company received “very encouraging feedback from the FDA providing a clear path forward” for MicroLine, but at that time said the company would provide more details “in the coming weeks.”

If approved, MicroLine would go up against AbbVie’s Vuity, which is a pilocarpine eye drop approved by the FDA in late 2021 for presbyopia. That drug didn’t do very well. In September 2022, AbbVie decided to reduce sales and marketing activities around Vuity, contributing to a pre-tax impairment charge of $770 million in the third quarter of 2022.

Eyenovia also developed MicroPine, a microdose formulation of atropine for the prevention of progressive myopia, or nearsightedness, in children. The drug was licensed to Bausch + Lomb, with Eyenovia on tap for potential royalty payments in the ballpark of “several hundred million dollars,” according to the company.