Roche Introduces Vabysmo® (faricimab): First Bispecific Monoclonal Antibody for Treating Leading Causes of Vision Loss

 

Mumbai: “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 several vision-threatening retinal conditions. It neutralizes 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 destabilizing blood vessels in the eye.

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, stabilizing blood vessels in the retina and improving vision outcomes.

“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.

Commenting on the launch, V Simpson Emmanuel, CEO and Managing Director, of 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 cataracts 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 bringing 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 recognize 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.

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 people 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 globally4,5 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.

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