Key Takeaways

  • Susvimo, an injection-free approach that provides continuous delivery of medicine to the eye through a refillable implant, showed positive two-year safety and efficacy results for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR).
  • Genentech has filed an application with the FDA for approval of the implant for the treatment of DME and DR. 

Two-year Phase III data presented at the 2024 American Society of Retina Specialists annual meeting show Genentech’s Susvimo™ port delivery system’s potential as an alternative to eye injections to treat diabetic macular edema (DME) and diabetic retinopathy (DR). The results build on the primary one-year analyses of the Phase III Pagoda and Pavilion studies, with Susvimo demonstrating sustained efficacy and  over two years.

Susvimo, a refillable capsule the size of a rice grain, provides continual release of ranibizumab, an anti-VEGF protein that blocks the growth of vision-robbing, leaky blood vessels, which are hallmarks of DME and DR. Susvimo is implanted at the surface of the eye during a one-time, outpatient surgical procedure. It may be refilled as infrequently as twice a year, thereby reducing the treatment burden for patients. Other diabetic eye disease therapies require regular injections into the vitreous, the soft gel in the middle of the eye.

Susvimo was previously approved by the US Food & Drug Administration (FDA) in October 2021 for the treatment of wet age-related macular degeneration (AMD), an eye disease that causes damage to the centermost part of the retina, but was voluntarily recalled by Genentech in October 2022 after reports of dislodgement of the device’s septum, a self-sealing interface through which ranibizumab is administered into the implant both prior to insertion and during refills. Genentech recently announced that they have fixed this problem and are relaunching Susvimo. They have also applied to the FDA for approval of Susvimo for the treatment of DME and DR. 

Edited by Miriam Kaplan, PhD

Sources:

Genentech press release, July 18, 2024; see press release

Foundation Fighting Blindness, Eye on the Cure Research News, July 8, 2024; see source article