Hanall Biopharma has submitted an investigational new drug (IND) for the second phase 3 clinical trial (VELOS-3) of its dry eye treatment, HL036 ophthalmic solution (ingredient: Tanfanercept), to the U.S. Food and Drug Administration.

Hanall Biopharma has applied for additional clinical trials of its dry eye treatment, HL036, to the U.S. FDA.
Hanall Biopharma has applied for additional clinical trials of its dry eye treatment, HL036, to the U.S. FDA.

In the U.S., if the initial IND plan maintains its validity, the following trials can be conducted without a separate procedure of approval, and HL036 belongs to such a case, according to Hanall Biopharma. “Hence, with the start of the VELOS-3 trial in the third quarter of this year, it is anticipated that topline results will be available in the first half of next year,” the company said.

VELOS-3 evaluates the safety and effectiveness of HL036. It will be conducted on 300 xerophthalmia patients in nine U.S. hospitals. Hanall plans to divide the patients into two groups and go through two weeks of screening. After that, it will administer its product and comparison drug twice a day for eight weeks. It will then evaluate the degree to which corneal damage is recovered and improvements in the eyes' discomfort.

Hanall Biopharma had proven the effects and safety of using Tanfanercept for dry eye patients through the first phase3 trial (VELOS-2) in the U.S. Through VELOS-3, Hanall plans to enact its safety and effects once again.

In addition, the phase 2 trial conducted by its partner company, Harbour Biomed in China, also showed a successful outcome in line with the one from the U.S. Phase 3 trial is going on in China for RA certificate from the beginning of this year, the company said.

Xerophthalmia shows symptoms of irritation like sore eyes due to damaged surface of the eye, declines in tears, or dried-out tears. With excessive use of smartphones and environmental changes like fine dust, the number of dry eye patients is rising. According to Market Scope, a market research store, the global xerophthalmia market is growing by 7 percent a year to an estimated 7 trillion won ($6.27 billion) in 2027.

“This trial aims to reconfirm the effects of HL036 proven through VELOS-2 trial in the U.S.,” Hanall Biopharma CEO Jeong Seung-won said. “We will work hard to develop effective bio-medication for the convenience of all xerophthalmia patients worldwide.”

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