AffaMed Technologies Announces TFDA Approval of MINI WELL, MINI WELL PROXA, MINI WELL TORIC and MINI 4 Ready IOLs for Cataract Treatment in Taiwan

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SHANGHAI, March 20, 2023 /PRNewswire/ -- AffaMed Technologies, a joint venture established between AffaMed Therapeutics and SIFI S.p.A., today announced that the Taiwan Food and Drug Administration ("TFDA") has approved its MINI WELL, MINI WELL PROXA, MINI WELL TORIC and MINI 4 Ready intraocular lens ("IOL") surgical implants for use in cataract treatment in Taiwan.

MINI WELL, MINI WELL PROXA and MINI WELL TORIC are presbyopia-correcting IOLs that can provide progressive extended depth-of-focus ("EDOF") vision correction to patients after cataract surgery, with MINI WELL TORIC^® able to correct up to 3.0D of corneal astigmatism. These surgical implants represent the most advanced solutions for cataract refractive surgery, allowing correction of myopia / hyperopia, presbyopia and corneal astigmatism resulting in spectacle-free uninterrupted high-quality vision at all distances and in all lighting conditions. MINI 4 Ready is an aspheric mono-focal IOL.

Dr. Yi Han, General Manager of AffaMed Technologies commented, "We are delighted that our line of IOLs is now one step closer to cataract patients and surgeons in Taiwan, especially the premium innovative MINI WELL, MINI WELL PROXA and MINI WELL TORIC, which can provide quality vision to patients at all distances for daily tasks and activities."

Dr. Dayao ZHAO, CEO of AffaMed Therapeutics commented, "These regulatory approvals mark important milestones for our company and illustrate Affamed's dedication to develop and commercialize high-quality and differentiated treatment solutions in Greater China. We look forward to a successful launch of our advanced IOL solutions in Taiwan and bringing their significant benefits in vision correction to patients in the near future."

About MINI WELL EDOF IOL

Developed by SIFI S.p.A., 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 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 represents the world's first Wavefront progressive EDOF IOL offering great visual acuity at far, intermediate and near distances, 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 MINI WELL PROXA EDOF IOL

MINI WELL PROXA is designed to bridge the gap in near vision (30-35cm) typically associated with EDOF technology. It maintains the same qualitative and technical characteristics of MINI WELL while ensuring spectacle-free rading ability at 30-35 cm.

About MINI WELL TORIC EDOF IOL

MINI WELL TORIC is the Toric version of MINI WELL. In addition to all optical characteristics that MINI WELL possesses, the toric posterior surface is designed to compensate pre-surgical corneal astigmatism up to 3.0D.

About MINI 4 Ready IOL

MINI 4 Ready is a one-piece UV-filtering aspheric mono-focal IOL for the posterior chamber that can be implanted in the capsular bag to replace the human crystalline lens in the correction of aphakia in adult patients.

About AffaMed Technologies

Established in 2021, AffaMed Technologies is the joint venture between AffaMed Therapeutics and SIFI S.p.A., a leading international ophthalmology company headquartered in Italy, to develop, manufacture and commercialize premium IOLs in Greater China market.

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.

SOURCE AffaMed Therapeutics Ltd.