Vyluma Announces Positive Results From Second Stage of Phase III CHAMP Study of NVK002 for the Treatment of Myopia in Children
Retrieved on:
Wednesday, October 11, 2023
During the fourth year of the study, both doses of NVK002 -- the 0.01% and 0.02% concentrations -- continued to exhibit a strong safety profile with a low level (8% incidence) of Treatment Emergent Adverse Events (TAES) and no evidence of meaningful rebound in subjects who had discontinued active treatment and were washed out over one year. In year four, NVK002 0.01% data indicate a continued widening of the previously reported treatment effect1 in both the mean change from baseline in Spherical Equivalent Refraction (SER), and mean change from baseline in axial length endpoints when compared to a matched historical placebo group. There was no evidence of tachyphylaxis in the treatment effect after four years.
Key Points:
- Analysis of the results of this multi-center, international study conducted after four years of treatment and follow up, show continued strong safety, the absence of rebound upon washout of the study drug, and continued efficacy for NVK002 as a potential treatment for myopia in children.
- “With the completion of the second and final phase of CHAMP, Vyluma continues its progress towards bringing NVK002 forward as an important new, first-in-class pharmaceutical treatment option for children with myopia.
- The NDA for NVK002 is currently under review with the FDA, and a decision is expected in January 2024,” stated Founder & Chairman, Navneet Puri PhD.
- In June 2023 Vyluma announced that the U.S. Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) for NVK002.