The board of directors of the Ocumension Therapeutics announced that biologic license application (BLA) for OT-702 (Aflibercept Intravitreous Injection, EYLEA® biosimilar) has been accepted by the Center for Drug Evaluation (?CDE?) of the National Medical Products Administration of the People?s Republic of China (the ?PRC?) recently. OT-702 was co-developed by the Group and its partner Shandong Boan Biotechnology Co. Ltd. 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 the PRC.

OT-702, as a soluble trapping receptor, 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. OT-702 is a biosimilar to EYLEA®, the globally approved indications of which include neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), diabetic retinopathy (DR), myopic choroidal neovascularization (mCNV) and retinopathy of prematurity (ROP). According to Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilars issued by CDE, OT-702 is eligible to apply for approval for all indications approved for EYLEA® in the PRC.

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 the phase I clinical trial of OT-702 showed that the safety and tolerability of OT-702 demonstrated in the trial group were consistent with and comparable to those of the original reference drug demonstrated in the original reference drug group. The phase III clinical trial of OT-702, 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, was completed in April 2024.

The results of the phase III clinical trial demonstrated clinically significant improvement in the eye?s best corrected visual acuity (BCVA) under study at weeks 4, 8, 12, 16, 20 and 24 compared with the baseline (by using the early treatment of diabetic retinopathy study (ETDRS) visual acuity chart) for the patients in both trial group and original reference drug group. The therapeutic effectiveness of OT-702 and the original reference drug is highly comparable, where the onset of action of both is rapid and lasting, signifying the fulfillment of all clinical trial endpoints.