Hanall Biopharma Seeks FDA Approval for Dry Eye Treatment
Hanall Biopharma has submitted a new investigational drug (IND) for the second Phase 3 clinical trial (VELOS-3) of its treatment for dry eye, HL036 ophthalmic solution (ingredient: Tanfanercept), to the United States Food and Drug Administration -United.
In the United States, if the original IND plan remains valid, subsequent trials can be conducted without a separate approval process, and HL036 belongs to such a case, according to Hanall Biopharma. “Therefore, with the start of the VELOS-3 trial in the third quarter of this year, it is expected that the first results will be available during the first half of next year,” the company said.
VELOS-3 evaluates the safety and efficacy of HL036. It will be carried out on 300 patients with xerophthalmia in nine US hospitals. Hanall plans to divide the patients into two groups and go through two weeks of screening. After that, he will administer his product and comparator twice a day for eight weeks. He will then assess the degree of recovery from corneal damage and improvement in eye discomfort.
Hanall Biopharma has proven the effects and safety of using Tanfanercept for patients with dry eye in the first phase 3 trial (VELOS-2) in the United States.
In addition, the phase 2 trial conducted by its partner company, Harbor Biomed in China, also showed a positive result consistent with that of the ongoing US phase 3 trial in China for the RA certificate since the start of this year, the company said.
Xerophthalmia has symptoms of irritation such as sore eyes due to a damaged surface of the eye, decreased tears, or parched tears. With the excessive use of smartphones and environmental changes like fine dust, the number of patients suffering from dry eye is increasing. According to Market Scope, a market research store, the global xerophthalmia market is growing by 7% annually to reach approximately 7 trillion won ($ 6.27 billion) in 2027.
“This trial aims to reconfirm the effects of HL036 proven by the VELOS-2 trial in the United States,” said Jeong Seung-won, CEO of Hanall Biopharma. “We will work hard to develop effective biomedications for the comfort of all xerophthalmia patients around the world. “