Reproxalap has shown improved results in reducing symptoms of dry eye disease and ocular redness. Credit: Ground Picture / Shutterstock.

Aldeyra Therapeutics has met the primary endpoint in a Phase III clinical trial of the Reproxalap drug for dry eye disease.

Reproxalap is an investigational new drug candidate which is also being developed for the treatment of allergic conjunctivitis.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The Phase III randomised, double-masked, vehicle-controlled dry eye chamber study demonstrated that 0.25% reproxalap ophthalmic solution was statistically superior to vehicle in reducing ocular discomfort.

In the trial, 132 patients were exposed to a dry eye chamber, with half of them receiving Reproxalap and the other half a vehicle.

The primary endpoint measured ocular discomfort from 80 to 100 minutes within the chamber.

See Also:

The US Food and Drug Administration (FDA) has provided feedback on the trial protocol and statistical plan, and the positive results are expected to support a potential new drug application (NDA) resubmission this year, the company said.

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.

A first-in-class small-molecule modulator of RASP, reproxalap has shown improved results in reducing symptoms of dry eye disease and ocular redness.

The drug has been well-tolerated in trials, with over 2,500 patients studied and no significant safety concerns reported. The most common adverse event was mild and transient instillation site discomfort.

Aldeyra president and CEO Todd Brady said: “To our knowledge, the results announced today represent the first positive Phase III clinical trial in a dry eye chamber with a symptom as a primary endpoint, and we believe that the results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease.”