Update on FDA Approval of Low Dose Atropine for Myopia Management

Are you eagerly awaiting news of FDA approval for low dose atropine for myopia management? Several pharmaceutical companies are pursuing FDA approval and are finalizing Phase III clinical studies for review. Currently low dose atropine for myopia management is prescribed as an off-label use by doctors to slow the progression of myopia, backed by numerous international studies including the ATOM 1 and 2 and LAMP 1 and 2 studies. Currently only 1% atropine is commercially available at a pharmacy, so to get the low concentrations (0.01 to 0.05% atropine) required for effective myopia management, doctors must use compounding pharmacies. FDA approval of a commercially available low concentration atropine for myopia management would allow for easier access and wider utilization of this treatment option. Here’s what we know so far about the three commercial products currently in Phase III status: 

NVK002 (Vyluma) 

preservative free 0.01 and 0.02% atropine

The final Phase III CHAMP trial data was published in October 2023, including international data of over 500 children and 4 years of study data. The data showed statistically significant slowing of spherical equivalent and axial length growth with 0.01 and 0.02% atropine use. An FDA Prescription Drug User Fee Act (PDUFA) date was scheduled for 1/31/24 but there has been no further news as that date came and went. A PDUFA date is set typically 6-10 months after the original study data has been sent to the FDA for review, but occasionally the PDUFA date is extended if the FDA requests more data before making a determination. 

MicroPine (Eyenovia) 

0.01% and 0.02% in the microdose Optejet dispenser

The Optejet dispense makes it easier to insert eye drops, sending a gentle spray of drop directly onto the eye without having to hold the eye open.

Phase III CHAPERONE study began enrolling patients in 2019 and has an expected end date of June 2028. In a press release from  January 2024, Eyenovia plans to “accelerate and engage the FDA on expediting development” after a slight slowdown as Eyenovia and Bausch and Lomb worked out licensing agreements. 

Eyenovia's patented Optejet Dispenser via

SYD-101 (Sydnexis)

0.01% and 0.03% atropine with a pH stabilizing agent

A pH stabilizing agent would help reduce the risk of stinging with drop insertion

Phase III STAR study is ongoing and not yet published. Estimated completion is 2025 with an early read out expected in May 2024 per the company's website. 

What about FDA approval of myopia management glasses? 

Currently FDA approved myopia management is only available with contact lens options, so for patients or parents who want to slow the progression of their child's prescription changes, but aren't ready for contact lenses, there is nothing available to them with FDA approval. In addition to FDA approval of low dose atropine, myopia management glasses are also pending with the FDA. In February 2024 the FDA granted "Breakthrough Device Designation" to SightGlass Vision's Diffusion Optics Technology (DOT) myopia management glasses. This designation means the FDA is "fast-tracking" the review and approval process to bring this device to market. If approved by the FDA, this would be the first myopia management glasses option available in the US (currently they are already available in Europe, Asia, and Canada). 

SightGlass Vision DOT myopia management glasses are being fast-tracked for approval by the FDA via