Vyluma has reported positive top-line data from the second stage of the Phase III Childhood Atropine for Myopia Progression (CHAMP) clinical study of NVK002 for the treatment of myopia in children.
The investigational, preservative-free eye drop NVK002 is intended for patients aged three to 17 and administered during the night.
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Analysis of the results of the global, multi-centre study, conducted after four years of treatment and follow-up, demonstrated continued efficacy, safety and the absence of rebound upon washout of the drug.
Both 0.01% and 0.02% doses of NVK002 exhibited a strong safety profile with a low level (8% incidence) of treatment-emergent adverse events.
No evidence of meaningful rebound was observed in participants who did not continue active treatment and were washed out over one year.
In year four, the NVK002 0.01% arm indicated a continued widening of the treatment effect reported earlier in the mean change from baseline in Spherical Equivalent Refraction.
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By GlobalDataThis group also showed a mean change in axial length endpoints from baseline against a matching historical placebo group.
No evidence of tachyphylaxis was found in the treatment effect after four years.
Vyluma founder and chairman Navneet Puri said: “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 new drug application (NDA) for NVK002 is currently under review with the US Food and Drug Administration (FDA) and a decision is expected in January 2024.”
The FDA provided a Prescription Drug User Fee Act goal date of January 31, 2024, to review the NDA for NVK002.
