Gelonghui, April 8 | Okanvision Bio-B (01477.HK) announced that the phase III clinical trial of OT-702 (abercip intraocular injection solution, EYLEA biosimilar) has been successfully completed in China. OT-702 was jointly developed by the Group and its partner Shandong Boan Biotechnology Co., Ltd. (“Boan Biotech”) (the company's shares are listed on the Hong Kong Stock Exchange Limited (stock code: 6955)). The phase III clinical study of OT-702 was carried out in cooperation between the two parties, and the application for the new drug will be submitted to the Drug Evaluation Center of the China National Drug Administration in the near future.
According to the cooperation and exclusive promotion agreement signed by the two parties in October 2020, the Group and Boan Biotech shall jointly promote the phase III clinical trial of OT-702, and the Group shall be granted the exclusive right to promote and commercialize this product in mainland China.
OT-702 is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein ophthalmic injection. As a biosimilar of EYLEA (abacip intraocular injection solution), OT-702 is suitable for treating patients with neovascularized wet age-related macular degeneration (WaMD), post-retinal venous occlusion (RVO) macular edema, diabetic macular edema (DME), diabetic retinopathy (DR), pathologic myopia, and premature retinopathy (ROP). As a soluble decoy receptor, OT-702 can bind to cytokines such as VEGF-A, VEGF-b, and PLGF to block downstream VEGFR signaling pathways, inhibit angiogenesis, and reduce vascular permeability, thereby treating pathological neovascularization eye diseases of the retina and choroid.
The completed pre-clinical head-to-head comparative study of OT-702 and EYLEA (abibasip intraocular injection solution) shows that OT-702 is highly similar to EYLEA in terms of physico-chemical properties and biological activity. The results of its phase I clinical trial showed that OT-702 has good safety and tolerability. The completed phase III clinical trial is a randomized, double-blind, parallel-controlled multicenter clinical trial aimed at comparing the efficacy and safety of OT-702 and EYLEA in treating wet age-related macular degeneration. The clinical trial results showed that in the two groups of patients who underwent clinical trials, the optimal corrected visual acuity (BCVA) of the study showed significant clinically significant improvements over the baseline at 24 weeks (using the Early Diabetic Retinopathy Treatment Study (ETDRS) visual acuity chart), which was equivalent.