AffaMed Technologies (“AffaMed”), the joint venture established between AffaMed Therapeutics and SIFI S.p.A., to develop, manufacture and commercialize premium intraocular lenses (“IOLs”) in the Greater China market, today announced the completion of the first patient implantations of its progressive Extended Depth-of-Focus (“EDOF”) IOLs conducted in Boao, China under the "Early and Pilot Implementation" policy. AffaMed’s MINI WELL® and MINI WELL TORIC® IOLs were successfully implanted during phacoemulsification cataract surgical procedures performed at Hainan (Boao) International Eye and Vision Hospital by Professor Wei CHEN, President of Hainan (Boao) International Eye and Vision Hospital and Vice President of Wenzhou Medical University's Eye and Vision Hospital.
Commenting on the successful completion of the surgeries, Professor Wei CHEN said, "Driven by increases in income and the desire for a higher quality of life, a growing number of patients are now demanding higher quality IOLs. Whereas the original objective for cataract surgery was to just restore eyesight, patients now seek the opportunity to gain clearer and more natural vision. In recent years, as electronic screens continue to penetrate our daily life, it has become especially important to obtain excellent intermediate and near visual acuity and high-quality vision. EDOF IOLs based on non-diffractive optical design have become a new focus area for future IOL development due to their higher light utilization, reduced optical interference, continuous jump-free vision, and a shorter cerebral nerve adaptation period, which are of great concern to patients and doctors. AffaMed’s MINI WELL® and MINI WELL TORIC® represent the latest advances in EDOF IOL technology based on non-diffractive optical design to be introduced into the China market. These IOLs adopt the patented Wavefront progressive technique, which makes the crystal surface as smooth and flat as a monofocal lens, together with an optical utilization rate close to that of a monofocal lens, but with greatly improved the visual quality. The MINI WELL TORIC® IOL can also efficiently correct corneal astigmatism while maintaining all the advantages of the MINI WELL® IOL".
Dr. Dayao ZHAO, CEO of AffaMed Therapeutics commented, "With appreciation for the guidance of the authorities in Boao and Hainan, and with the strong support of the medical experts from Hainan (Boao) International Eye and Vision Hospital and Wenzhou Medical University's Eye and Vision Hospital, we are very pleased to have completed these first patient implantations so shortly after receiving approval for pilot use of our EDOF IOLs by the Hainan NMPA and National Health Commission. These successful surgeries represent an important next step in bringing the benefits of our innovative MINI WELL® and MINI WELL TORIC® EDOF IOLs to more domestic ophthalmic patients. AffaMed is committed to bringing the world's leading products and technologies into China, providing patients with better treatment solutions and improving their quality of life. We will build on this momentum and further accelerate the registration of our IOLs to benefit patients nationwide as soon as possible."
About MINI WELL® and MINI WELL TORIC® EDOF IOLs
Developed by SIFI S.p.A. ("SIFI"), a leading international ophthalmology company headquartered in Italy, MINI WELL® and MINI WELL TORIC® EDOF IOLs are . innovative IOL implants for the 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® IOLs are 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® IOLs represent the world’s first Wavefront progressive EDOF IOLs offering great visual acuity at all distances, fluent reading speed, smooth vision transition from near to far, contrast sensitivity within normal range, and negligible halos and glare, all resulting in great patient satisfaction.
MINI WELL TORIC® is an EDOF aspheric IOL for the correction of presbyopia and astigmatism maintaining all the advantages of the MINI WELL® IOL, and is expected to be the first TORIC EDOF IOL to be available to patients in China. The MINI WELL TORIC® intraocular lenses are intended for primary implantation for visual correction of aphakia and pre-existing corneal astigmatism in adults 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 TORIC® IOLs offer functional vision at all distances for astigmatic cataract patients, great visual acuity at all distances, smooth vision transition from near to far, rotational stability, quality of vision, and negligible halos and glare.
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. The leadership team of AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally.
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.
