Research & Development
Nevakar doses first Myopia under 18 subject in Phase 3 clinical trial of NVK-002
22 November 2017 -

Pharmaceutical company Nevakar LLC stated on Tuesday that it has started treatment of its first subject under its Phase 3 clinical trial of NVK-002 for the treatment of myopia (nearsightedness) in children aged 3 to 17 years.

The company said NVK-002 is its investigational, topical ophthalmic solution that is intended to slow the progression of myopia in children.

Following a successful Phase 3 and the US Food and Drug Administration (FDA) approval, NVK-002 would represent the first pharmacologic eye drop for this patient population, according to the company.

Concurrently, the company's Phase 3 trial will enroll 500 subjects aged three to 17 years with myopia Spherical Equivalent Refraction (SER) of at least -0.50 D and no greater than -6.00 D in each eye. It will be conducted in two stages. Stage one will evaluate the safety and efficacy of two concentrations (low dose and high dose) of NVK-002 as compared to placebo for slowing the progression of myopia over a three-year period. Stage two will be a randomized cross-over phase of one year in duration.

In conjunction, NVK-002 will be evaluated against the primary endpoint of a statistically significant overall between-group difference from baseline in the proportion of subjects who show

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