Clinical-stage drug development firm RegeneRx Biopharmaceuticals licensee GtreeBNT has obtained approval from the Ministry of Food and Drug Safety (MFDS) in Korea to carry out a Phase IIb / III clinical trial of GBT-201 (RGN-259) in patients with dry eye syndrome (DES).

GBT-201 is a sterile and preservative-free eye drop developed to treat eye disorders, such as DES and neurotrophic keratopathy (NK) among others.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The study will be a multi-centre, randomised, and double-masked trial, which will include approximately 360 patients with DES.

The trial will assess the efficacy and superiority of GBT-201 compared to a placebo.

"Approval to initiate the Korean dry eye study represents a significant milestone for GBT-201 / RGN-259."

RegeneRx Biopharmaceuticals president and CEO JJ Finkelstein said: "Approval to initiate the Korean dry eye study represents a significant milestone for GBT-201 / RGN-259.

See Also:

"The Gtree team has been working very hard to prepare for this clinical trial, and we have been working closely with them to help expedite this effort."

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.

RGN-259 includes active ingredient is Thymosin beta 4 (TB4). It found to demonstrate statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures, based on US Phase II clinical trials in moderate and severe dry eye syndrome.

Based in Gyeonggi-do of South Korea, G-treeBNT is developing GBT-201, its first drug candidate for dry eye syndrome in 28 Asian and Pacific Rim countries.