The board of directors of Ocumension Therapeutics announced that, the phase III clinical trial of OT-702 (aflibercept intravitreous injection, EYLEA biosimilar) has been successfully completed in China. OT-702 was co-developed by the Group and its partner Shandong Boan Biotechnology Co. Ltd. The phase III clinical trial of OT-702 was jointly conducted by both parties, and its new drug application (NDA) will be submitted to the Center for Drug Evaluation of National Medical Products Administration of China in the near future.

Pursuant to the cooperation and exclusive promotion agreement entered into by both parties in October 2020, the Group, together with Boan Bio, shall co-advance the phase III clinical trial of OT-702, and the Group was granted the exclusive right to promote and commercialize the product in mainland China. OT-702 is a recombinant human vascular endothelial growth factor receptor antibody fusion protein ophthalmic injection. As a biosimilar to EYLEA (aflibercept intravitreous injection), OT-702 is indicated for the treatment of patients with neovascular wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), choroidal neovascularization (CNV) and retinopathy of prematurity (ROP) in pathological myopia.

As a soluble trapping receptor, OT-702 can bind to cytokines such as VEGF-A, VEGF-B and P1GF, inhibit the downstream signaling pathway of VEGFR, inhibit neovascularization, and reduce vascular permeability, thereby treating pathological neovascularization of the retina and choroid eye diseases. The completed pre-clinical head-to-head comparison study of OT-702 to EYLEA (aflibercept intravitreous injection) showed OT-702 shared a high degree of similarity in both physical and chemical properties and biological activities with EYLEA. The results of its phase I clinical trial showed that OT-702 has a good safety and tolerability profile.

The completed phase III clinical trial of OT-702 is a randomized, double-blind, parallel-controlled and multicenter clinical study to compare the efficacy and safety of OT-702 to EYLEA in the treatment of wet age-related macular degeneration. The results of this clinical trial demonstrated clinically significant improvement in the eye's best corrected visual acuity (BCVA) under study at 24 weeks compared with the baseline (by using the early treatment of diabetic retinopathy study (ETDRS) visual acuity chart) for both groups of patients subject to the clinical trial to an equivalent extent.