Gwangdong Pharmaceutical's Presbyopia Eye Drop "Ubegye" Wins U.S. FDA Approval...Domestic Review Underway

Product approval application submitted to MFDS

Gwangdong Pharmaceutical announced on the 13th that Ubegye, a presbyopia treatment for which it holds exclusive distribution rights in Korea, has obtained approval from the U.S. Food and Drug Administration (FDA).

Gwangdong Pharmaceutical logo image. Gwangdong Pharmaceutical

Ubegye is an ophthalmic solution developed by the global biotech company Tenpoint Therapeutics. It is a combination drug that combines 2.75% carbachol and 0.1% brimonidine tartrate. Its mechanism of action involves inducing a pinhole effect through pupil constriction, thereby improving near visual acuity and depth of focus. When administered once daily, its effects appear approximately 30 minutes after instillation and last for up to 10 hours.

This approval was based on the results of Phase 3 clinical trials (BRIO I and II) conducted in more than 800 patients. In the trials, uncorrected near visual acuity in both eyes improved in a statistically significant manner, and no deterioration in distance vision was observed. Long-term 12?month studies also confirmed safety and tolerability.

Gwangdong Pharmaceutical secured the domestic distribution rights by signing an exclusive license agreement for the Asian region with Hong Kong-based Jiaoker in 2024. The company applied for product approval to the Ministry of Food and Drug Safety in September last year, and the review is currently underway. The FDA approval is expected to be used as a reference indicator in the domestic approval review process.