Affamed Technologies Announces Taiwan FDA Approval of MINI WELL EDOF IOL Series and MINI 4 Ready IOL for Cataract Treatment

ShanghaiMarch 20, 2023PR Newswire -- AffaMed Therapeutics, in collaboration with SIFI S.p.A. ("SIFI"), announced today through their jointly established company in China, Affamed Technologies (AffaMed), that the Extended Depth-of-Focus (EDOF) intraocular lenses MINI WELL, MINI WELL PROXA, and MINI WELL TORIC, as well as the single-focus intraocular lens MINI 4 Ready, have received approval from Taiwan's Food and Drug Administration for use in cataract surgery.

MINI WELL, MINI WELL PROXA, and MINI WELL TORIC are presbyopia-correcting intraocular lenses that provide patients with good vision at far, intermediate, and near distances after being implanted through cataract surgery, increasing the depth of field. MINI WELL TORIC also has the function of correcting preoperative corneal astigmatism of 3.0D or less. These three lenses represent the most advanced refractive cataract solutions currently available, capable of correcting myopia, hyperopia, presbyopia, and corneal astigmatism, helping patients achieve spectacle independence post-surgery and delivering high-quality vision at all distances under various lighting conditions. MINI 4 Ready is a monofocal aspheric intraocular lens.

Dr. Han Yi, General Manager of AffaMed Technologies, stated: "We are delighted that our series of intraocular lenses is now closer to cataract patients and doctors in Taiwan, especially the three high-end innovative lenses MINI WELL, MINI WELL PROXA, and MINI WELL TORIC. The functional characteristics of these three lenses can provide patients with more convenience in their daily work and life after surgery."

Dr. Dayao Zhao, CEO of AffaMed Therapeutics, stated: "The recent regulatory approvals mark a significant milestone in the company’s development and demonstrate AffaMed Therapeutics' commitment to developing and commercializing high-quality, differentiated therapeutic solutions in Greater China. We look forward to the upcoming launch of our products in Taiwan to benefit patients with enhanced visual quality."