A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye

Phase 3 Completed 260 enrolled HanAll BioPharma Co., Ltd. Daewoong Pharmaceutical Co. LTD. · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.

Timeline

Start: 2021-11-18
Primary completion: 2022-05-06
Completion: 2022-05-06

Outcome

Missed primary endpoint

registry analysis (superiority test); 0.25% Tanfanercept Ophthalmic Solution vs Placebo; p = 0.764; LS Mean Difference -0.03 (95% CI -0.214 to 0.157); MMRM NCT05109702 ↗

registry analysis (superiority test); 0.25% Tanfanercept Ophthalmic Solution vs Placebo; p = 0.144; LS Mean Difference 4.34 (95% CI -1.483 to 10.155); MMRM NCT05109702 ↗

release “The Phase III VELOS-3 trial did not demonstrate statistical significance for either of the two primary efficacy endpoints” hanall.com ↗

Publications

Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

Drugs

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