Nevakar announced that the first subject has been dosed in a phase 3 clinical trial of NVK-002, the company's investigational, topical ophthalmic solution intended to slow the progression of myopia in children. If successful in phase 3 and then in obtaining approval from the FDA, NVK-002 would represent the first pharmacologic eye drop for this patient population.
"Dosing of the first phase 3 subject with NVK-002 is a key milestone for the company and we are excited about this product's potential to improve the quality of life for millions of children," Navneet Puri, PhD, founder and chief executive officer of Nevakar, said in a company news release.
Dr. Puri continued, "According to industry sources, the prevalence of myopia is expected to affect over 50% of the global population by the year 2050, with the number of people experiencing high myopia, the most severe form of the disease, reaching over 900 million. Given that the condition progresses the fastest during early childhood and adolescence, treatment at this stage is of critical concern. Without effective intervention, patients are at increased risk of developing vision-threatening conditions later in life including blindness related to maculopathy, and retinal detachment, among others. Unfortunately, simple corrective lenses do not halt disease progression, and there is currently no FDA-approved eye drop to treat and slow down advancement of the disease. If successful in phase 3 and approved, NVK-002 would offer an important therapeutic option to this underserved population, improving quality of life, and alleviating the associated economic burden on society."
The phase 3 trial will enroll approximately 500 subjects aged 3 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. The three-arm, randomized, multicenter, double-masked, placebo-controlled trial 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 3-year period. Stage two will be a randomized cross-over phase of 1 year in duration.
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 <-0.50 D progression at the month 36 visit. As key secondary endpoints, NVK-002 will be evaluated to determine whether it meets preset criteria for: between-group difference in the mean progression rates at 12, 24 and 36 months of treatment; between-group difference in the proportion of subjects who show <-0.75 D progression at the month 36 visit; and, between-group median time to a change in myopia of <-0.75 D.