Vyluma, Inc. announced that the FDA has accepted for review its new drug application (NDA) for NVK002 (low-dose atropine 0.01%) as a potential therapy for pediatric myopia.
Refresh me on NVK002.
As Vyluma’s lead compound, NVK002 is a preservative-free, low-dose atropine formulation developed by Vyluma that features proprietary technology to address stability, tolerability, and safety for the treatment of myopia.
The eye drop is designed to be administered nightly.
Didn’t the company just release data on it?
Good memory! Just last month, Vyluma released positive data from the landmark, 3-year, placebo-controlled phase 3 Childhood Atropine for Myopia Progression (CHAMP) study that supported the potential use of NVK002 for myopia progression in patients ages 3 to 17 years of age.
NVK002 exhibited favorable safety and tolerability, with no serious ocular adverse events noted.
Give me some details from the findings.
NVK002 at a dose of 0.01% (compared to NVK002 0.02%) achieved statistically significant and clinically meaningful differences at Month 36 in its key outcome measures:
- Responder analysis
- Mean change from baseline in spherical equivalent refraction (SER)
- Mean change from baseline in axial length
What’s next?
The FDA has designated January 31, 2024, as the Prescription Drug User Fee Act (PDUFA) date.
Significance?
NVK002 could become the first approved pharmacological treatment option for myopia progression.