SHANGHAI, March 3, 2023 /PRNewswire/ — AffaMed Technologies ("AffaMed"), a joint venture established between AffaMed Therapeutics and SIFI S.p.A., today announced the completion of the first patient implantation in the Registrational Clinical Trial of its MINI WELL® progressive Extended Depth-of-Focus ("EDOF") IOL (MINI WELL®), which was conducted in the EYE & ENT Hospital of Fudan University in Shanghai, China. This phacoemulsification cataract surgical procedure was successfully led by Professor Yi Lu, Director of Ophthalmic Research Institute, and his study team.
Professor Yi Lu commented that "With its innovative optical design and excellent performance, MINI WELL® achieves extended depth of focus, improves the patient’s distance, intermediate and near vision acuity, and significantly reduces the risk of visual disturbance. We are very pleased to have successfully completed the first implantation under the MINI WELL® China Registrational Clinical Trial. As a nationally leading site, the ophthalmology study team of the EYE & ENT Hospital of Fudan University will execute this clinical study with high quality and believe that this study will be successfully completed."
Dr. Han Yi, General Manager of AffaMed Technologies commented, "In the future, we will continue our efforts to accelerate the development of innovative intraocular lenses to China market with the aim to bring more choices to cataract and refractive patients in China and to benefit the patients with high-quality and high-end products."
Dr. Dayao ZHAO, CEO of AffaMed Therapeutics commented, "We greatly appreciate the efforts of Prof. Yi Lu and the team. The success of this first implantation marks an important step in the development of MINI WELL® for the China market. We look forward to continuing clinical development of MINI WELL ® towards regulatory approval, and to be able to bring its significant benefits in vision correction to patients in China in the near future."
About MINI WELL® EDOF IOL
Developed by SIFI S.p.A. ("SIFI"), a leading international ophthalmology company headquartered in Italy, MINI WELL® EDOF IOL is an innovative IOL implant for the Greater China market, offering a great alternative to refraction, diffraction and segment-types mono/bi/tri-focal IOLs, as well as to diffraction-type EDOF IOLs. MINI WELL® is the first progressive EDOF aspheric IOL for presbyopia correction, to be implanted via mini-incision and through a capsular bag into the posterior chamber of the eye. MINI WELL® IOL is intended for primary implantation for visual correction of aphakia in adult patients with or without presbyopia after removal of a cataractous lens, and of aphakia after refractive lensectomy in presbyopic adults who desire increased spectacle independence for distance and near vision. MINI WELL® IOL represents the world’s first Wavefront progressive EDOF IOLs offering great visual acuity at far, intermediate and neardistances, fluent reading speed improvement at 40cm distance, smooth vision transition from near to far, contrast sensitivity within normal range, and negligible halos and glare, all resulting in great patient satisfaction.
About AffaMed Therapeutics
AffaMed Therapeutics is a clinical stage therapeutic company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmic, neurological and psychiatric disorders for patients in Greater China and around the world.
About AffaMed Technologies
Established in 2021, AffaMed Technologies is the joint venture between AffaMed Therapeutics and SIFI S.p.A. ("SIFI"), a leading international ophthalmology company headquartered in Italy, to develop, manufacture and commercialize premium intraocular lenses ("IOLs") in the Greater China market.