HBM9036 ophthalmic solution 0.25%, also known as tanfanercept, a novel TNF-α inhibitor, is safe and effective for improving certain symptoms of dry eye disease, according to results of a phase 2 randomized, a double-blind controlled clinical study using Controlled Adverse Environment.
Recent studies have indicated an increase in the incidence of this condition fueled by a global increase in aging population, increased use of smartphones, and higher levels of micro-dust in the environment. Artificial tears, the most used treatment in China, only provides symptomatic relief. With increasing burden and impact of DED on our society, HBM anticipates bringing this novel therapy to address patients’ needs soon.
To assess the efficacy and safety of HBM9036 as a treatment option for dry eye disease, the Massachusetts-based researchers conducted a randomized, double-masked, multicenter study. As part of the study, 637 subjects received HBM9036 0.25% or a placebo twice daily for 8 weeks. Primary endpoints for their research were mean change in inferior corneal staining score (ICSS) and ocular discomfort score (ODS) from baseline to week 8. Secondary endpoints included central corneal staining score (CCSS), total corneal staining score (TCSS), and eye dryness score (EDS).
HBM9036 is a new investigational TNF receptor-1 fragment, in adult patients with moderate-to-severe DED. It is a molecularly engineered as a therapy for relief of the signs and symptoms of DED and was specifically developed for ophthalmic topical use with tissue distribution, stability, and potency optimized for treatment of DED. In this proof-of-concept and comparability trial, HBM9036showed rapid onset of action, significant improvements in signs as measured by Corneal Staining Score, a measure of corneal damage. HBM9036 was very well tolerated with similar comfort level as placebo. These results are consistent with previously reported Phase II clinical trial (VELOS-1) conducted in the US. These favorable safety and efficacy results pave the way for a HBM9036 phase III clinical trial.
While HBM9036 did not improve ICSS (P =.187), the team’s findings show that it did significantly improve CCSS (P =.024) and TCSS (P =.045) at week 8. More specifically, improvement in CCSS was observed as early as week 1 (P =.048) and was maintained until week 8 of the study. The investigators noted a stronger significance at week 8 in the subgroup of more severe patients at baseline (P <.001). HBM9036 also improved ODS at week 2 and week 4, and significantly improved EDS at week 8 for subjects using artificial tears within 30 days of their first visit (P =.033).
Title: TNF-α inhibitor HBM9036 Ophthalmic Solution demonstrates efficacy in the treatment of moderate to severe dry eye disease (DED) – Results of phase 2 randomized, a double-blind controlled clinical study using Controlled Adverse Environment