First Subject Dosed in Nevakar’s Phase III Trial of NVK-002 for Myopia in Children

November 24, 2017: By Jon Swedien

Nevakar announced Nov. 21 that the first subject has been dosed in its Phase III clinical trial of NVK-002 for myopia in children.

NVK-002 is a topical ophthalmic solution intended to slow the progression of myopia in children. If it receives US FDA approval, NVK-002 would be the first pharmacologic eye drop for this patient population, Nevakar said.

The Phase III trial will enroll about 500 subjects ages 3 to 17 who have myopia spherical equivalent refraction (SER) of at least -0.50 diopters and no greater than -6.00 diopters in each eye. The three-arm, randomized, multicenter, double-masked, placebo-controlled trial will be conducted in two stages.

The first will evaluate the safety and efficacy of two concentrations (low dose and high dose) of NVK-002 compared with placebo for slowing progression of myopia over a three-year period. The second stage will be a randomized cross-over phase of one year in duration.

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