• HEALTH Health / Pharma

Roche launches Vabysmo® (faricimab), the first and only bispecific monoclonal antibody for the eye, to treat two leading causes of vision loss.

• nationalherald
• March 6, 2024

by Prashant Kapadia/NHN

• Vabysmo targets and inhibits two disease pathways that cause neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME)

• Vabysmo’s revolutionary dual-pathway mechanism of action (MoA) neutralises angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability for patients living with nAMD and DME

• Vabysmo is the only injectable eye medicine approved for both nAMD and DME, with a dosing interval of up to every 16 weeks (once in 4 months) ^1,2

Mumbai, March 05, 2024: Roche Pharma India marked its foray into the Ophthalmology space by launching Vabysmo® (faricimab) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). Neovascular AMD and DME are two leading causes of vision loss worldwide.

Vabysmo® is the first and only dual-pathway-inhibitor that uniquely targets and inhibits two disease pathways linked to a number of vision threatening retinal conditions. It neutralises both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) which are key proteins involved in the development and progression of retinal conditions, contributing to vision loss by destabilising blood vessels in the eye. ^1,2

As the world’s first bispecific monoclonal antibody, Vabysmo is a single molecule designed to target and inhibit the effects of two targets, providing the benefits of two medicines in one. Current treatment options target VEGF alone, and therefore only partially address the biology of the disease. By blocking both pathways involving Ang-2 and VEGF-A, Vabysmo® offers people the first new MoA (mechanism of action) in more than 15 years for nAMD and close to a decade for DME, stabilising blood vessels in the retina and improving vision outcomes. ^1,2

Vabysmo® has the potential to transform the existing Standard of Care (SoC) as the burden associated with currently available treatment options for nAMD and DME such as frequent eye injections (typically required every one to two months) and physician visits can lead to under treatment and less-than-optimal vision outcomes. Vabysmo® offers better treatment durability with patients requiring eye injections at intervals of up to once in four months, while achieving similar vision gains and anatomical improvements ^1,2.

Commenting on the launch, V Simpson Emmanuel, CEO and Managing Director, Roche Pharma India, said, “We believe more should be done to meet the needs of people living with retinal conditions and to preserve sight. While there is strong awareness and action for cataract and other frontal eye-disorders, retinal conditions are often diagnosed late or neglected, leading to vision loss. The launch of Vabysmo® marks our entry into the ophthalmology space in India, underscoring our commitment to bring the best-in-class innovations to the country. With fewer eye injections over time, while also improving and maintaining vision and anatomy, Vabysmo® offers a more convenient and effective treatment schedule for patients, their caregivers and healthcare systems.”

“nAMD and DME can limit a person’s ability to read, drive and recognise faces. Even simple everyday activities may become challenging as the disease progresses. Vabysmo® offers the ‘Latest’ (world’s first dual pathway inhibition), ‘Fastest’ (fastest drying & effective disease control) and ‘Longest’ (extended durability up to 4 months) treatment option to patients,” said Dr. Viraj Suvarna, Chief Medical Officer at Roche Pharma India. ^1,2

Padma Shri, Prof Dr. S Natarajan, Chief Clinical Services – Aditya Jyot Eye Hospital, Chief of Vitreoretinal Services – Dr. Agarwals Eye Hospital, said: “Combating Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) presents formidable challenges. Both conditions threaten the precious gift of sight, affecting millions worldwide. However, with the advent of Vabysmo, a revolutionary treatment offering targeted therapy, we now possess a powerful tool to confront these challenges head-on. Vabysmo’s unique mechanism of action offers hope by inhibiting the underlying pathological pathways involved in AMD and DME, thereby preserving vision and improving patients’ quality of life.”

Preventable and treatable vision loss is a growing global public health concern. A staggering 1 billion people³ live with vision impairment worldwide that could have been prevented. Retinal conditions are now affecting more people than ever before. More than ~300 million patients globally^4,5 and ~11 million patients in India⁶ suffer from retinal vision loss. India is home to one-third of the blind population of the world ⁷. Furthermore, in India, the prevalence of nAMD and DME stands at approximately 4 million^8,9.

Vabysmo® (faricimab) was first approved by the USFDA in January 2022. It is today available in across 90+ countries and more than 2 million doses have been administered till date ¹¹.

About neovascular age-related macular degeneration

Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading.Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or brosis.Worldwide, around 20 million people ¹⁰ are living with nAMD – the leading cause of vision loss in people over the age of 60 ⁴ and the condition will affect even more people around the world as the global population ages.

About Diabetic Macular Edema : Affecting around 21 million people globally¹², diabetic macular edema (DME) is a vision threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving.The number of people with DME is expected to grow as the prevalence of diabetes increases.There remains a signi cant unmet need for more effective, longer-lasting therapies for people with DME.

About Roche Products (India) Pvt. Ltd.: Roche Products (India) Private Limited was incorporated in 1994 as a wholly owned subsidiary of the Roche Group, headquartered in Basel, Switzerland. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. A leader in oncology treatment in India; apart from cancer, Roche has innovative medicines in other therapy areas too: transplantation, rheumatoid arthritis (RA), and chronic kidney disease (CKD)-related anaemia. For more information on Roche Pharma India, visit http://www.rocheindia.com