Saturday, July 13, 2024

Macular Degeneration Treatment Advances with FDA Approval of Updated Susvimo

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The U.S. Food and Drug Administration (FDA) has approved updates to Susvimo, now available for US retina specialists and patients with neovascular age-related macular degeneration (nAMD). Susvimo offers the first alternative to regular eye injections, which are the standard care for nAMD affecting 20 million people globally. By continuously delivering medicine to the eye through a refillable implant, Susvimo is the first and only approved neovascular age-related macular degeneration treatment shown to maintain vision with two refills a year.

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

Continuous Delivery Implant for Macular Degeneration Now Meets FDA Standards

Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other treatments require multiple eye injections per year. The implant is surgically inserted during a one-time outpatient procedure and refilled every six months using a specially designed needle. Susvimo, approved by the FDA in 2021, was recalled in 2022 due to performance issues with some implants. After updates to the implant and refill needle, and manufacturing process improvements, Susvimo now meets performance standards.

Roche is committed to making this innovative drug delivery system available globally. This is one of the multiple options Roche continues to develop to meet the needs of people with nAMD and other eye conditions, including diabetic macular edema. Age-related macular degeneration (AMD) affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or ‘wet’ AMD can cause rapid and severe vision loss if untreated, due to abnormal blood vessel growth under the macula.

Macular Degeneration

Innovative VEGF Inhibitor Implant for Macular Degeneration by Roche

Susvimo continuously delivers a customized formulation of ranibizumab, a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein critical in new blood vessel formation. This formulation is different from the ranibizumab intravitreal injection, marketed as Lucentis, which has been approved to treat neovascular age-related macular degeneration since 2006. Roche’s innovative therapies aim to save eyesight from leading causes of vision loss through pioneering treatments.

Roche’s extensive retina pipeline in ophthalmology is led by science and informed by patient insights. Their pipeline includes gene therapies and treatments for multiple vision-threatening conditions, such as diabetic eye diseases, geographic atrophy, and autoimmune conditions like thyroid eye disease and uveitic macular edema. With a commitment to innovation, Roche continues to bring breakthrough ophthalmic treatments to people living with vision loss.

 

Resource: Roche, July 08, 2024

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