Bio-Thera’s Anti VEGF Therapy for w-AMD Meets Phase III Endpoint, Prepares for Market Filing
— Reported by DengYueMed
On June 24, 2024, Bio-Thera Solutions, Ltd. announced that its anti VEGF humanized monoclonal antibody BAT5906 has successfully met the primary endpoint in a pivotal Phase III clinical trial for the treatment of wet age-related macular degeneration (w-AMD).
This randomized, double-blind, parallel-controlled Phase III trial (CTR20221092) evaluated the efficacy of BAT5906 compared to ranibizumab (Lucentis).
The trial was co-led by Prof. Chen Youxin from Peking Union Medical College Hospital and Prof. Liu Xiaoling from the Eye Hospital of Wenzhou Medical University—both recognized leaders in China’s ophthalmology field.
🔬 Key Findings:
- Central Retinal Thickness (CRT): BAT5906 significantly outperformed ranibizumab in reducing CRT from baseline to Week 52, indicating stronger inhibition of neovascular leakage and inflammation.
- Best-Corrected Visual Acuity (BCVA): A higher proportion of patients treated with BAT5906 achieved an improvement of more than 15 letters at Week 52, showing superior vision restoration.
Given the positive results, Bio-Thera is preparing for regulatory submission of BAT5906, aiming to bring better treatment options to patients with w-AMD.
🧠 About w-AMD and Anti VEGF Drugs
Age-related macular degeneration (AMD) is a major cause of irreversible vision loss worldwide.
In China, with the rapidly aging population, the number of AMD patients is projected to exceed 55 million by 2050, posing a growing public health and economic burden.
Anti-VEGF drugs, delivered via intravitreal injection, have become the standard of care for neovascular AMD, helping restore macular anatomy and improve visual function.
*The information provided is for informational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Please consult a healthcare professional before making any medical decisions.
