FDA Accepts sBLA for Susvimo in Treatment of DME, Diabetic Retinopathy

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Susvimo, formerly known as the Port Delivery System with ranibizumab, for the treatment of diabetic macular edema (DME) and diabetic retinopathy.¹

Announced by Roche on July 18, 2024, the filing was accepted based on the 1-year study results from the Phase 3 Pagoda and Pavilion studies. Both studies met their primary endpoints, with Susvimo achieving non-inferior visual acuity gains from baseline to monthly ranibizumab and superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) to clinical observation, respectively.

“If approved by the FDA, Susvimo can bring a new treatment paradigm for diabetic eye diseases,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech.¹ “We hope to bring this option to people with DME and diabetic retinopathy as soon as possible to help maintain their vision and potentially their independence.”

Susvimo 100 mg/mL for intravitreal use via ocular implant is surgically inserted into the eye during an outpatient procedure and continuously delivers a customized formulation of ranibizumab over time.

Treatment for DME regularly requires intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents. In Pagoda, patients with DME who received Susvimo refilled every six months achieved non-inferior visual gains compared with those receiving monthly 0.5 mg ranibizumab.

Approximately 95% of patients with DME did not need additional treatment with supplemental injections during the primary analysis at 64 weeks.

In Pavilion, patients with diabetic retinopathy who received Susvimo refilled every nine months achieved superior DRSS improvements versus those under monthly clinical observation. No Susvimo-treated patients required additional treatment with supplemental anti-VEGF injections during the primary analysis at 52 weeks, compared with 60% in the control arm.

Updated two-year data from the Pavilion and Pagoda trials were presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting, with Susvimo demonstrating sustained efficacy over two years and consistent results with the known safety profile for Susvimo in people with DME and diabetic retinopathy.

“These efficacy and safety results demonstrate that Susvimo can deliver robust vision outcomes over two years for people with diabetic eye diseases that can cause vision loss,” Garraway added.

Susvimo was previously approved for treating neovascular (wet) age-related macular degeneration (AMD) in October 2021.² By October 2022, Genentech voluntarily recalled Susvimo after the ocular implant, insertion tool, and initial fill kit after test results failed to perform to the company’s standards.³

On July 8, 2024, Genentech signaled the reintroduction of Susvimo, marking the end of a voluntary recall, after the FDA granted a post-approval supplement to the BLA based on component-level updates to the ocular implant and refill needle.⁴

In the release, Genentech declared their plan to make Susvimo available to US retina specialists for the treatment of nAMD in the coming weeks.

“It’s exciting that Susvimo is coming back,” Arshad Khanani, MD, managing partner, and director of clinical research, at Sierra Eye Associates, told HCPLive. “It’s an implant in the eye, so there are risk-benefit discussions that need to be done with patients, but over the last 8 years, we have had a lot of learnings to improve the safety profile. In terms of efficacy, it is really exciting to see that patients are doing well long-term.”

Reference

1. _{Genentech: Press releases: Thursday, Jul 18, 2024. New Data for Genentech’s Susvimo Demonstrates Sustained Efficacy in Two Serious Diabetic Eye Conditions. July 18, 2024. Accessed July 23, 2024. https://www.gene.com/media/press-releases/15034/2024-07-18/new-data-for-genentechs-susvimo-demonstr.}
2. _{Kunzmann K. FDA approves port delivery system with ranibizumab for WET AMD. HCP Live. October 22, 2021. Accessed July 8, 2024. https://www.hcplive.com/view/fda-approves-port-delivery-system-ranibizumab-wet-amd.}
3. _{US DHCP voluntary recall of the SUSVIMO ocular implant ... Accessed July 8, 2024. https://www.gene.com/download/pdf/Susvimo_DHCP_Important_Prescribing_Information_2022-10-18.pdf.}
4. _{Iapoce C. Genentech announces reintroduction of Susvimo for Wet Amd. HCP Live. July 8, 2024. Accessed July 23, 2024. https://www.hcplive.com/view/genentech-announces-reintroduction-of-susvimo-for-wet-amd.}