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HanAll Biopharma Submits IND for Second Phase 3 (VELOS-3) of HL036 in Dry Eye Disease


Related Data

- Efficacy and safety evaluation of HL036 (INN: tanfanercept) eye drops optimized for local inflammatory diseases

- VELOS-3 in progress, following VELOS-1 (Phase 2) and VELOS-2 (1st Phase 3)

- In the third quarter of this year, the trial will commence in the U.S. in 300 patients living with dry eye disease


HanAll Biopharma (KRX: 009420.KS)​ announced the 22nd that it has submitted an IND for the second Phase 3 clinical trial (study name: VELOS-3) to the FDA for investigational dry eye disease treatment HL036 (tanfanercept), which is being developed in collaboration with Daewoong Pharmaceutical.


VELOS-3 will start in the third quarter of this year, and top-line results from the study​ is expected in the first half of next year.


The VELOS-3 is a Phase 3, multicenter, randomized, double-masked and placebo-controlled study evaluating the efficacy and safety of tanfanercept (HL036) ophthalmic solution 0.25% compared to placebo in subjects with Dry Eye. Following screening for two weeks, 300 patients with dry eye disease will be randomized into study group or placebo and administered twice daily tanfanercept or placebo for eight weeks, repectively.


Tanfanercept demonstated statistical significance in central corneal staining score (CCSS) and total corneal staining score (TCSS) versus placebo and shown a favorable safety profile in the previous Phase 3 study VELOS-2. Additionally, Chinese partner Harbour BioMed has also drawn results consistent with the US clinical trials through a Phase 2 clinical trial for dry eye disease conducted in China, and has been conducting a pivotal Phase 3 trial in China since the beginning of this year.


“The goal of this clinical trial is to replicate the efficacy of HL036, which was shown in the VELOS-2 clinical trial,” said Seungwon Jeong, M.D., Chief Executive Officer of HanAll Biopharma. “We will do our best to develop a new biologic product that is effective and comfortable to use for dry eye disease patients around the world.”


Dry eye disease is an prevalent eye condition that causes eye surface damage and symptoms of irritation such as sore eyes due to insufficient tears or excessive evaporation of tears. The number of patients is increasing due to excessive smartphone use and environmental changes such as fine dust. According to the market research firm Market Scope, the global dry eye disease market is expected to grow at an CAGR of 7% from 2017 to 2017 reaching $7 billion.