HanAll Biopharma, a subsidiary of Daewoong Pharmaceuticals, said Tuesday that it has begun phase 3 clinical trials for HL036, a dry eye treatment, in the United States.
HL036 is a new biological drug that can treat dry eye syndrome which causes eye surface damage, irritation and foreign body sensation caused by lack of tears or excessive evaporation. It has a new mechanism of inhibiting TNFα that causes inflammation in the eye.
The trial, titled VELOS-2, will randomly divide 630 patients with dry eye syndrome into two groups and will either administer HL036 0.25 percent twice a day for eight weeks or a placebo to compare the efficacy and safety of the treatment.
The goal is to draw aggregate data from 11 clinical trial centers throughout the U.S., from March to December.
Phase II clinical trials for the drug, completed on 150 patients last year, has shown that both Inferior Corneal Staining Score and Ocular Discomfort Score improved rapidly compared to placebo before and after exposure to a dry environment.
The company plans to present the final results of the trial at the Association for Research in Vision and Ophthalmology 2019 in Canada next month.
“HL036 Entry into Phase 3 clinical trials in the U.S. will become a milestone in HanAll's focus on global bio drug development,” HanAll Biopharma CEO Park Seung-kook said. “By statistically confirming the excellent clinical effects of HL036, the drug will become an innovative treatment in the area of dry eye syndrome where there is a high unmet need.”