Hanall Biopharma Submits Plan for Phase 3-2 Clinical Trial of New Dry Eye Drug to US FDA

[Asia Economy Reporter Kim Ji-hee] HanAll Biopharma announced on the 22nd that it has submitted the Investigational New Drug (IND) application for the second Phase 3 clinical trial of the dry eye treatment 'HL036 Eye Drops' (active ingredient: Tanfanercept), which is being jointly developed with Daewoong Pharmaceutical, to the U.S. Food and Drug Administration (FDA).

The company explained that in the U.S., once the initial clinical trial plan submitted to the FDA remains valid, subsequent clinical trials can proceed without separate approval procedures. HL036 Eye Drops meet this condition, and the company expects to start the clinical trial in the third quarter of this year and confirm topline results by the first half of next year.

This clinical trial aims to replicate the evaluation of the efficacy and safety of HL036 Eye Drops. It will be conducted at nine ophthalmology hospitals in the U.S. with 300 dry eye patients. HanAll Biopharma will divide the patients into two groups, conduct a two-week screening, and then administer the test drug and control drug twice daily for eight weeks, respectively. The plan is to assess the degree of corneal damage recovery and improvement in ocular discomfort.

Separately, the Chinese partner company, Harbor Biomed, is also conducting a Phase 3 clinical trial in China for product approval.

Seungwon Jung, CEO of HanAll Biopharma, stated, “The goal of this clinical trial is to reconfirm the efficacy of HL036 observed in the first U.S. Phase 3 clinical trial,” adding, “We will strive to develop a bio new drug that is effective and comfortable for dry eye patients worldwide.”

This content was produced with the assistance of AI translation services.