Yakup News reported on September 28 that RudaCure’s dry eye candidate RCI001/HL262 is entering a Phase 2 trial in Korea. The clinical trial plan was approved on September 22.
The multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of the 0.25% eye drop in 200 patients, starting with a twice-daily (BID) arm of about 100 patients dosed for 12 weeks. Whether to develop four-times-daily (QID) dosing will be decided from the interim data. RudaCure is co-developing the candidate with Hanlim Pharm.
Phase 1 evaluated safety, tolerability and pharmacokinetics. Site activities are planned to start in October, with interim data targeted for March to May 2027. Patient efficacy remains to be established in Phase 2.
Read the original Yakup News article (Korean)
RudaCure’s Phase 2 approval announcement
Updated November 6, 2026: dosing-arm sequence and timeline corrected to the company-confirmed plan.