Roche to relaunch Susvimo for US nAMD patients

Roche has announced the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use through an ocular implant for treating neovascular or "wet" age-related macular degeneration (nAMD) in the United States. This follows the conclusion of a voluntary recall. The FDA has approved a post-approval supplement to the Biologics License Application for Susvimo, addressing updates made to the ocular implant and refill needle. Roche plans to make Susvimo available to retina specialists and patients with nAMD in the coming weeks.

Susvimo offers an innovative alternative to the frequent eye injections typically required for nAMD treatment, impacting around 20 million people worldwide. This condition can lead to blindness if untreated. By using a refillable implant, Susvimo continuously administers medicine to the eye, requiring just two refills per year to maintain vision, as demonstrated in Phase III studies.

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, expressed enthusiasm for the reintroduction of Susvimo. He emphasized that this unique therapeutic approach, which maintains vision with semi-annual refills, reflects Roche’s commitment to providing innovative retinal treatments and lays a foundation for future advancements.

Susvimo uses the Port Delivery Platform to deliver a customized formulation of ranibizumab, differentiating it from other treatments that necessitate multiple annual injections. The implant is surgically inserted during a one-time outpatient procedure and is refilled every six months using a specially designed needle that introduces ranibizumab directly into the implant.

Originally approved by the FDA in 2021, Susvimo was recalled by Roche the following year due to some implants not meeting performance standards. Roche has since updated the implant and refill needle, ensuring they meet performance expectations. Additionally, manufacturing process improvements have been implemented.

Roche remains dedicated to making this novel drug delivery system available globally and continues to develop various options to meet the needs of individuals with nAMD and other prevalent eye conditions, such as diabetic macular edema.

Age-related macular degeneration (AMD) affects the part of the eye responsible for sharp, central vision, essential for activities like reading. nAMD is an advanced form of AMD that can cause rapid and severe vision loss if untreated. It occurs when abnormal blood vessels grow uncontrollably under the macula, leading to swelling, bleeding, and fibrosis. Approximately 20 million people worldwide suffer from nAMD, making it the leading cause of vision loss in individuals over 60. As the global population ages, the number of people affected by this condition is expected to rise.

The Susvimo implant administers a customized formulation of ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor designed to bind and inhibit VEGF-A. This protein plays a crucial role in forming new blood vessels and the leakiness of these vessels.

This formulation of ranibizumab differs from the ranibizumab intravitreal injection marketed as Lucentis, which was first approved by the FDA in 2006 for treating nAMD and other retinal diseases.

Roche is focused on preventing vision loss through pioneering therapies. Their scientific innovations in drug discovery, personalized healthcare, molecular engineering, and continuous drug delivery aim to design the right therapies for the right patients. Roche boasts the broadest retina pipeline in ophthalmology, driven by scientific insights from individuals with eye diseases. This includes gene therapies and treatments for various vision-threatening conditions, such as diabetic eye diseases, geographic atrophy, and autoimmune conditions like thyroid eye disease and uveitic macular edema.

Leveraging its extensive experience, Roche has introduced groundbreaking ophthalmic treatments for those experiencing vision loss. Susvimo, previously known as the Port Delivery System with ranibizumab, was FDA-approved in 2021. Another notable treatment, Vabysmo (faricimab), is the first bispecific antibody approved for the eye, targeting and inhibiting two signaling pathways linked to numerous retinal conditions, including nAMD and diabetic macular edema.

Founded in 1896 in Basel, Switzerland, Roche is a global leader in biotechnology and in-vitro diagnostics. Renowned for its dedication to scientific excellence, Roche continuously works to discover and develop medicines and diagnostics that enhance and save lives worldwide. As a pioneer in personalized healthcare, Roche collaborates with various stakeholders, combining strengths in diagnostics and pharmaceuticals with data insights from clinical practice. Recognized as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices, Roche is committed to improving healthcare access globally.

In the United States, Genentech is a wholly-owned member of the Roche Group, and Roche is the majority shareholder in Chugai Pharmaceutical, Japan.