US-based specialty pharmaceutical firm Nevakar has started dosing patients in a Phase III clinical trial to assess its investigational candidate NVK-002 for myopia (nearsightedness) in children.
NVK-002 is a topical ophthalmic solution being developed to slow the progression of the condition.
The randomised, multi-centre, double-masked, placebo-controlled three-arm trial is designed to evaluate NVK-002 in around 500 patients aged between three and 17 years.
While the first stage of the trial will investigate the safety and efficacy of two concentrations of the investigational agent over three years, the second stage will be performed as a randomised cross-over study for one year.
Nevakar founder and CEO Navneet Puri said: “Given that the condition progresses the fastest during early childhood and adolescence, treatment at this stage is of critical concern.
“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 III 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 trial’s primary endpoint is statistically significant overall difference in the proportion of subjects achieving progression of <-0.50D from baseline to the month 36 visit, when compared to placebo.
Key secondary endpoints will include difference in the mean progression rates at 12, 24 and 36 months, proportion of subjects with <-0.75D progression at the month 36 and median time to a change in myopia of <-0.75D.