Vyluma Discusses Response to FDA’s Questions and Clarifies Regulatory Pathway for its 505(b)(2) NDA, NVK002 to slow the progression of myopia in children.
Vyluma announces Marketing Authorisation Application (MAA) validation for the EU for NVK002 to slow the progression of pediatric myopia.
BRIDGEWATER, N.J., Oct. 11, 2023 (GLOBE NEWSWIRE) -- Vyluma, Inc. (œVyluma), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced today positive...
BRIDGEWATER, N.J., June 06, 2023 (GLOBE NEWSWIRE) -- June 6, 2023 “ Vyluma, Inc. (œVyluma), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced...
BRIDGEWATER, N.J., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, today announced it...
BRIDGEWATER, N.J., Oct. 27, 2022 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, today announced top-line results from its Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study. Analysis of this multi-center, international study, performed after three years of treatment and follow up, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children. The results were shared today in an oral presentation at the American Academy of Optometry annual meeting in San Diego, CA.
BRIDGEWATER, N.J., Sept. 01, 2022 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced today that the last patient visit has been completed for the primary analysis of the pivotal Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study. The CHAMP study has been designed, in collaboration with FDA, to evaluate whether NVK002 eye drops are safe and effective as a treatment for the progression of myopia in children. With this milestone, Vyluma remains on track for primary analysis readout later this year and regulatory submission in 2023. NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly, which, if approved, would be the first-in-class pharmaceutical treatment for myopia progression in children.