The preservative-free eye drop NVK002 is intended for patients aged three to 17. Credit: Peak stock / Shutterstock.

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.

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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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This 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.