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