The FDA just accepted the investigational new drug application for MicroPine.
Explain that entire last sentence.
An investigational new drug application is when a pharmaceutical company is given permission to test their experimental drug on real humans and ship it across state lines to test said drug at multiple different centers.
Got it. What is MicroPine?
MicroPine is a formulation of low dose atropine given to slow myopia progression. This builds off of the work of the ATOM1 and ATOM2 studies. Now that the company has the go ahead from the FDA, they will begin enrolling kids between the ages of 5-12 in their CHAPERONE clinical trial.
Anything else cool about this?
Yes, MicroPine is unique because it delivers atropine in “microdrops”. Microdrops are a smaller amount of an eye drop that delivers the same therapeutic effect. Typical eye drop bottles dispense roughly three times the amount that an eye can hold. Microdrops dispense the exact amount the eye can hold and Eyenovia has the proprietary technology. See their eye-dropper-of-the-future here
Why could this be a big deal?
1. The microdrops technology could be a hit given that smaller drops limit surface toxicity and Eyenovia is trying to apply this to all areas of therapeutics (glaucoma, allergy, etc).
2. This could be the first FDA approved atropine therapy for myopia control.