Pharmacokinetics, safety and preliminary efficacy of conbercept eye drops for corneal neovascularization: Results from phase I/IIa studies.

Authors

Qi Shen, Pei Shu, Zhenlei Wang, Jin Yuan, Zhiqiang Pan, Cheng Pei, Jing Hong, Yanning Yang, Mingchang Zhang, Xiao Ke, Xinguo Wang, Zhu Luo, Ke Ma, Yingping Deng

Published in

British journal of clinical pharmacology. Aug 17, 2026. Epub Aug 17, 2026.

Abstract

Vascular endothelial growth factor (VEGF) drives corneal neovascularization (CorNV), yet no anti-VEGF eye drops are clinically available. We report phase I/IIa trials of KH906, a novel topical anti-VEGF agent.
Trial 1 was a phase I, open-label, dose-escalation study in healthy adults receiving KH906 at 0.1, 0.5, or 1.0 mg/mL. Trial 2 was a phase I, multicentre, open-label, dose-escalation study in patients with CorNV at the same doses. Trial 3 was a phase IIa, randomized, double-masked, placebo-controlled study assigning patients 1:1:1 to 0.5 mg/mL KH906, 1.0 mg/mL KH906, or placebo. Primary endpoints were safety, tolerability and pharmacokinetics (Trials 1 and 2) and safety, tolerability and efficacy (Trial 3).
From 10 December 2018 to 16 June 2021, 18 healthy participants and 39 patients with CorNV were enrolled. One treatment-related adverse event occurred: a mild corneal epithelial defect in the 1.0-mg/mL group in Trial 3. No serious or other drug-related adverse events were observed. In Trial 2, KH906 reduced the CorNV area and vessel length. In Trial 3, at Day 28, mean changes in CorNV area were -1.2 (0.8), -1.6 (1.1) and -0.7 (1.1), and mean changes in CorNV length were -8.0 (7.3), -6.6 (5.9) and -1.7 (7.9), in the 0.5-mg/mL KH906, 1.0-mg/mL KH906 and placebo groups, respectively. The 1.0-mg/mL dose produced greater reduction of the CorNV area than lower doses, indicating a dose-response effect.
KH906 appears safe and well tolerated and demonstrates preliminary efficacy in reducing CorNV, with higher doses showing greater effect, supporting further clinical development.

PMID:
42608019
Bibliographic data and abstract were imported from PubMed on 18 Aug 2026.

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