ReGenTree, the U.S. subsidiary of Gtree BNT, said that it has managed to enroll 200 patients in its U.S. phase 3 clinical trial ARISE-3, which is a study of its dry eye treatment, RGN-259.
The trial is a two-week study on 700 dry eye patients at 19 ophthalmology clinics across the U.S., and will compare the safety and efficacy of RGN-259 against a placebo.
Dry eye syndrome is a multifactorial disease caused by various causes that accompanies pain, itching, redness, and dryness due to homeostatic damage to the tear film.
Although the global market is around 3 trillion won ($2.5 billion), there are only two original products sold in the U.S. market. However, both products induce eye burns while administering the drug and do not show improvement until 12 or 24 weeks of administration.
Gtree BNT has confirmed through previous phase 3 clinical trials – ARISE-1 and ARISE-2 -- that patients do not suffer from a burning sensation while administering the drug. The company has also confirmed the drug's safety and efficacy as it managed to establish the treatment's effect after two weeks of administration.
"Because dry eye syndrome is particularly common during the dry winter months, a large number of subjects are expected to be recruited from December to February," Gtree BNT CEO Yang Won-suk said. "We will make efforts to obtain good results for the study within the third quarter of next year."