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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
“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.