A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye

Phase 2 Completed 100 enrolled Harbour BioMed (Guangzhou) Co. Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye

Timeline

Start: 2019-03-22
Primary completion: 2019-07-03
Completion: 2019-07-10

Outcome

Missed primary endpoint

paper ICSS pre- to post-CAE change from baseline scores when compared to placebo (- 0.61 ± 0.11 and - 0.54 ± 0.11, respectively; mean difference = 0.07, p = 0.65). PMID 35192105 ↗

release “the significant improvement effect of HL036 could not be verified through the ICSS(inferior corneal staining score), which was set as the primary endpoint” hanall.com ↗

Publications

Dong Y, Wang S, Cong L, Zhang T, Cheng J, Yang N, Qu X, Li D, Zhou X, Wang H, Lee M, Wang M, Chen S, Ousler GW, Chen X, Xie L. TNF-alpha inhibitor tanfanercept (HBM9036) improves signs and symptoms of dry eye in a phase 2 trial in the controlled adverse environment in China. Int Ophthalmol. 2022 Aug;42(8):2459-2472. doi: 10.1007/s10792-022-02245-1. Epub 2022 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	tanfanercept	Protein / enzyme biologic	0.25 %	Other