HanAll Biopharma announced that it has initiated a Phase III VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye based on the findings from the previous Phase III VELOS-3 study. Tanfanercept demonstrated statistically significant improvement on the secondary outcome measure, Schirmer testing of tear volume, from the previous Phase III study. The top-line data for the Phase III VELOS- 4 study is expected in the second half of 2025. Dry eye disease is a chronic multifactorial disease with a prevalence estimation of 14.5% for the US population. The available treatments for DED often prove insufficient in managing symptoms, occasionally resulting in visual impairment and ocular inflammation, alongside a low response rate that contributes to discontinuation. Thus, there is an unmet clinical need to develop mechanism-based and disease-modifying treatments. Tanfanercept is a potentially first-in-class topical anti-inflammatory treatment targeting tumor necrosis factor (TNF) for the treatment of DED, co-developed with Daewoong Pharmaceutical. DED-2, a preceding Phase III study, also demonstrated a consistent improvement in Schirmer testing in an adoc analysis that subset the population to be similar to that of patients studied in VELOS-3. The 2020 FDA Draft Guidance on Dry Eye Drug Development includes the proportion of participants with a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval. Top-line data from the Phase III VELOS-4 trial is anticipated in the second half of 2025.
VELOS-4 is a US-based multicenter, randomized, double-masked, vehicle-controlled Phase III study to evaluate the efficacy and safety of twice-daily tanfanercept ophthalmic solution (0.25%, 1.0%) for the treatment of adults
with moderate to severe DED compared to vehicle. The study assesses the proportion of patients who have shown 10mm or more improvement from baseline in an unanesthetized Schirmer test at day 85.