AffaMed Successfully Completes First-Ever Implantation of MINI WELL EDOF IOL in Aier Eye Hospital, Advancing Multimodal Clinical Solutions Centered on Disease Needs

Recently, AffaMed Therapeutics successfully performed procedures on two patients at Aier Eye Hospital in Boao Lecheng, Hainan.The First Aier Case of MINI WELL Extended Depth-of-Focus Intraocular Lens Implantation`, providing more treatment options for cataract patients.`

MINI WELL, developed by SIFI S.p.A., an internationally leading ophthalmic care company in Italy, and introduced by AffaMed Therapeutics, is an extended depth-of-field intraocular lens (EDOF IOL) based on non-diffractive optical design. MINI WELL is a progressive EDOF aspheric IOL used for presbyopia correction and is implanted into the capsular bag of the posterior chamber through a micro incision.

Based on the advanced design concept of MINI WELL, the product features a smooth transition of optically effective areas between each optical zone, providing excellent vision at all distances in a progressive manner without any "jump" in vision or halos. MINI WELL induces spherical aberration only at the pupil center, which increases depth of field to overcome presbyopia without compromising night vision. The product utilizes innovative wavefront technology to create positive and negative spherical aberrations at the optical center of the lens, extending its focal depth and thereby offering a wider range of continuous depth of field. This extended continuous focal depth provides excellent vision at various distances.

This first implant surgery by Aier was respectively performed byProfessor Chen Haibo, Vice President of Hainan Region, Aier Eye Hospital、Professor Li Dong, Executive Dean of Boao Lecheng Aier Eye HospitalLed the team to complete the procedure at Boao Licheng Aier Eye Hospital. The day after the surgery, patients Auntie Xie and Auntie Wang both achieved clear vision across continuous far, intermediate, and near ranges.

"Finally, I can see clearly!" Aunt Xie, a cataract patient, had a preoperative vision of only 0.2. After postoperative review, her distant, intermediate, and near vision reached 0.8, 0.8, and 1.0 respectively. The excellent visual experience made Aunt Xie unable to contain her joy, and she is now preparing to resume hobbies that she had given up on for many years due to blurry vision.

Professor Chen Haibo, Vice President of Hainan Region of Aier Eye Hospital, and Auntie Xie Pose for a Photo

Professor Li Dong, Executive Dean of Boao Lecheng Aier Eye Hospital, and Aunt Wang Pose for a Photo Together

It is understood that cataracts are the leading cause of blindness globally.Surgical implantation of artificial lenses is currently an effective treatment for cataracts.With the continuous advancement of science and technology, cataract surgery has transitioned from the era of restorative surgery to the era of refractive surgery. An increasing number of patients expect not only to regain sight after the operation but also to see clearly and sharply.

Zhang Jinsong, Group Leader of the Cataract Division at Aier Eye Hospital Group, General President of Aier Eye Hospital in Liaoning Province, and President of Shenyang Aier Excellence Eye HospitalCongratulations were extended online for the successful conduct of this surgery. He stated: "With the increase in social income and the pursuit of a better quality of life, more and more patients are demanding higher quality intraocular lenses (IOLs). In the past, the requirement was simply to restore vision, but now it has upgraded to achieving clearer and more natural vision. Currently, EDOF intraocular lenses based on non-refractive optical designs have become a new hotspot in the development of IOLs due to their high light utilization, minimal light interference, continuous vision without jumps, shorter brain adaptation time, excellent contrast sensitivity, and performance even in complex low-light environments. These features have drawn significant attention from both patients and doctors. MINI WELL and MINI WELL TORIC are the latest EDOF intraocular lenses based on non-refractive optical design introduced to the Chinese market. They utilize patented wavefront progressive technology, making the lens surface as smooth and flat as a monofocal lens, with optical utilization close to that of a monofocal lens, greatly improving imaging quality."

Dr. Dayao Zhao, CEO of AffaMed TherapeuticsExpressed: "We are very pleased to cooperate with Boao Lecheng Aier Eye Hospital to successfully complete the first implant surgery of Aier. At the same time, in order to further deepen the strategic cooperation with Boao Aier Eye Hospital, relying on the Aier Eye platform and Boao's innovative policies, we will cooperate to build a 'Clinical Research Cooperation Base for Innovative Products'. AffaMed Therapeutics will continue to vigorously promote the implementation and application of more ophthalmic products, benefiting more patients with eye diseases in China."

AffaMed Therapeutics is an innovative biopharmaceutical company committed toDevelop and commercialize drugs with revolutionary value to meet the needs of patients in Greater China and globally in the fields of ophthalmology, neurology, and psychiatric system disease treatments.Unmet critical medical needs.

Since its establishment, AffaMed Therapeutics has successfully built a multinational team of over a hundred people. The management team of AffaMed Therapeutics possesses deep expertise and has numerous successful cases in high-quality clinical development, regulatory affairs, Chemistry, Manufacturing, and Control (CMC), business development, and operations both in China and with leading global pharmaceutical companies.

Dr. Dayao Zhao, CEO of AffaMed Therapeutics, has nearly 30 years of experience in the biopharmaceutical industry. He has held senior management positions such as Head of R&D in China for Pfizer, Head of R&D in China for Janssen Pharmaceutical under Johnson & Johnson, and Head of R&D for Japan and the Asia-Pacific region at Genzyme. He has accumulated extensive experience in early drug discovery, clinical development, pharmacovigilance, medical affairs, and regulatory affairs.

In just three years, AffaMed Therapeutics has secured the development and commercialization rights for multiple international innovative products and established a self-research focus through its comprehensive professional knowledge and industry experience, driving the company's rapid growth. To date, AffaMed Therapeutics has completed its Series B financing round, with total funding exceeding 250 million US dollars.

With the aggravation of population aging and changes in social lifestyle, the incidence of ophthalmic diseases continues to increase and shows a trend of becoming younger. According to a report released by VCBeat in 2022, the problem of ophthalmic diseases in China is relatively serious, with 990 million people suffering from non-blinding eye diseases and 252 million people suffering from blinding eye diseases.

With the increase in the prevalence of ophthalmic diseases both in China and globally, the ophthalmic drug market has also grown rapidly. According to statistics from Frost & Sullivan, the global ophthalmic drug market reached $36.1 billion in 2021, with China's ophthalmic drug market at $3.7 billion, accounting for approximately 10%. It is predicted that China’s ophthalmic drug market will continue to rise, reaching $8.4 billion by 2026, which will represent 18.3% of the global market, with a compound annual growth rate (CAGR) of 17.8%, far exceeding the global ophthalmic drug market’s growth rate of 4.9% during the same period.

As a high-growth, high-barrier "double-high" track, the ophthalmology industry has long been known as the "golden track" in the capital market. In the "14th Five-Year Plan" for national health issued by the State Council in 2022, a separate notice on the national eye health plan was listed, bringing the ophthalmology industry back into the spotlight.

However, China's ophthalmic drug market started relatively late, and the research and development of innovative ophthalmic drugs is at a lower level. Since 2015, only seven new ophthalmic drugs have been approved in China, compared to 17 in the United States. There are substantial unmet clinical needs in China.

Focusing on highly unmet clinical needs, AffaMed Therapeutics centers on diseases and, with an experienced development team, actively expands its innovative product pipeline.Providing a unique multimodal targeted treatment solution across pharmaceuticals, medical devices, and digital therapeutics to unlock the powerful synergies of the product portfolio.`, bringing patients safer, more efficient, and more comprehensive disease treatment solutions.`

Currently, AffaMed Therapeutics has introduced premium intraocular lenses, lacrimal duct implants, and other products in the ophthalmology field. The company is also actively advancing its self-developed projects, such as bispecific biomolecules for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), striving to establish...A comprehensive ophthalmic solution for various ophthalmic diseases from the anterior segment to the fundus.

Ophthalmology Product Pipeline and Development Progress

Among them, DEXTENZA, used for inflammation and pain after ophthalmic surgery and ocular itching associated with allergic conjunctivitis, has received approval from the U.S. FDA and Macao ISAP for marketing. It has also obtained the rights to develop and commercialize DEXTENZA in the Greater China region, South Korea, and the ASEAN market. Currently, this product is undergoing a real-world clinical research project in the Hainan Pilot Zone.

AM712 is a novel bispecific biomolecule capable of simultaneously blocking vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), which can be used to treat various retinal diseases. A Phase I clinical trial conducted in the United States will study the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age-related macular degeneration (nAMD).

At the same time, AffaMed Therapeutics is continuously expanding and optimizing its portfolio of innovative drug candidates and digital therapeutics in the field of neurological and psychiatric disorders through collaborations with biopharmaceutical companies both in China and internationally, as well as through internal independent research and development.

The current products target indications including Post-Stroke Cognitive Impairment (PSCI), Attention Deficit Hyperactivity Disorder (ADHD), migraine, Social Anxiety Disorder (SAD), Parkinson's Disease (PD), myasthenia gravis, neuromyelitis optica, etc.

Neurology and Psychiatry Product Pipeline and Development Progress

Dr. Zhaodayao Zhao believes: "As a new therapy that has achieved excellent clinical performance in the fields of cognitive behavior, biofeedback, and neural oscillations, digital therapeutics brings more possibilities for treating diseases across different areas."

Looking to the future, Dr. Zhao Dayao stated: "AffaMed Therapeutics is a pharmaceutical technology company focused on developing globally innovative treatment methods to provide patients with better therapeutic options and improve their quality of life. On this basis, we will further accelerate the registration of related products, striving to benefit patients across China as soon as possible."