NVK002 FDA Approval Status
FDA Approved: No
Brand name: NVK002
Generic name: atropine
Dosage form: Ophthalmic Solution
Company: Vyluma, Inc.
Treatment for: Myopia
NVK002 (low dose atropine 0.01%) is an anticholinergic ophthalmic formulation in development for the treatment of myopia in children.
- Myopia (nearsightedness) is a vision disorder in which people can see close objects clearly, but objects farther away appear blurred.
- Myopia occurs when the the eye is longer than normal (axial elongation) from front to back, or the cornea is too steeply curved, which causes light to focus in front of the retina instead of directly on it.
- The exact mechanism in which NVK002 works to treat myopia is unclear. In clinical trials, low dose atropine has demonstrated meaningful impacts on myopia progression with a good safety profile.
- NVK002 is a preservative-free eye drop that is administered nightly.
- The FDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 31, 2024.
Development timeline for NVK002
| Date | Article |
|---|---|
| Jun 6, 2023 | Vyluma Announces FDA Acceptance of New Drug Application For NVK002, Its Novel Investigational Treatment For Pediatric Myopia |
Further information
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