Eyenovia, Inc. reported a less-than-stellar update on its phase 3 CHAPERONE study that’s evaluating a drug-device combination of low-dose atropine for pediatric progressive myopia:
The trial has failed to meet its primary endpoint.
Oh dear … let’s start from the beginning with this candidate.
Its name: MicroPine.
What it is: A drug-device combo comprising low-dose atropine with Eyenovia’s proprietary Optejet dispensing platform (which, essentially, dispenses eye drops).
- Its proposed indication: Reduction of progressive myopia in pediatric patients
Quick refresh on Optejet, please.
Eyenovia’s Optejet device is designed with a sterile-filled, replaceable drug cartridge with the specific purpose of dispensing topical eye medications for ocular therapeutics.
This hand-held, ergonomically-designed gadget (see a visual) includes:
- Spray nozzle with 109 laser-drilled ports
- Shutter
- Activation button
How it does this: By using the company’s Microdose Array Print (MAP) technology as a topical delivery system—similar to an inkjet printer.
What’s the process?
It’s pretty simple: Via the push of a button, medication is dispensed horizontally in a mist, coating the surface of the cornea.
- To note: Contact to the eye occurs at a low velocity in order to reduce ocular impact.
And for chronic medications: The device is intended to ensure patient adherence while providing real-time data to a physician.
Now let’s talk about this phase 3 study.
The U.S.-based, multicenter, randomized, double-masked trial (NCT03942419) was initiated in 2019 with the goal of enrolling 400+ pediatric patients (aged 3-12).
- Its purpose: To evaluate myopia progression among participants using a daily administration (in each eye) of MicroPine with microdosed:
- Atropine 0.1%
- Atropine 0.01%
- Placebo ophthalmic solution
- The study duration: 48 months of daily administration, with safety and efficacy assessments performed at the following time points after initiation: Months 1, 12, 18, 24, 30, and 36
- At 36 months: Participants were then re-randomized and followed at 6-month intervals for 1 year
And what was measured?
The sole primary outcome measure was myopia progression, as measured at 36 months.
How this was determined: By the number of eyes demonstrating < 0.50 D (spherical equivalent) myopia progression versus baseline (as measured via cycloplegic autorefraction).
Now … these findings.
To start:
- This safety and efficacy data was based on evaluations of 252 participants in the study
- The findings were reviewed by an independent Data Review Committee (DRC)
The bad news: The rate of myopia progression was not significantly different between the two active treatment arms (ie: atropine 0.01% and 0.1%) and placebo.
But on the plus side: Eyenovia also reported that, in the safety analyses, “all dosages and placebo appeared to be well-tolerated, with a mild and infrequent adverse event profile.”
Any specific numbers to go with this?
Not at the moment. According to Eyenovia, the full study data “has not yet been released” to the company.
Gotcha. So what’s the plan moving forward?
To put it bluntly: Termination.
This is according to CEO Michael Rowe, who, on behalf of the company, expressed disappointment in the DRC’s determination.
Next steps: Involve reviewing the data more thoroughly as well as “considering a variety of steps to maximize value to all stakeholders” in order to reduce expenses and evaluate options.
Any idea what those options may be?
The company name-dropped a few possibilities:
- Business combination
- Reverse merger
- Asset sales
- Combination of these
However, only time will tell. So, always, stay tuned!
Can we leave this on a positive note, at least?
We can! This recent study data notwithstanding, Eyenovia has been busy the last few months—from its U.S. commercial launch of clobetasol propionate for postop pain and inflammation to a number of new partnerships involving its Optejet system for dry eye.