FDA Accepts sBLA for Susvimo in Diabetic Eye Diseases Following Promising Phase 3 Results
核心洞察
The FDA has accepted Roche's supplemental Biologics License Application for Susvimo to treat diabetic macular edema (搜索) and diabetic retinopathy (搜索), based on successful Phase 3 trial results.
Susvimo, a refillable ocular implant that continuously delivers ranibizumab, demonstrated non-inferior visual gains compared to monthly injections in DME patients, with 95% requiring no additional treatment during the study period.
The treatment recently returned to the US market for wet AMD after addressing quality issues, potentially offering a paradigm shift in diabetic eye disease management by reducing the need for frequent injections.
The US Food and Drug Administration (FDA) has accepted Roche's supplemental Biologics License Application (sBLA) for Susvimo in the treatment of diabetic macular edema (搜索) (DME) and diabetic retinopathy (搜索), the company announced on July 18, 2024. The application is based on one-year results from the Phase 3 Pagoda and Pavilion clinical trials, which demonstrated the efficacy and safety of this innovative ocular implant system.
Promising Phase 3 Results Support Application
Both pivotal trials met their primary endpoints, with Susvimo achieving non-inferior visual acuity gains compared to monthly ranibizumab injections in DME patients (Pagoda trial) and superior improvements on the Diabetic Retinopathy (搜索) Severity Scale (DRSS) compared to clinical observation in diabetic retinopathy patients (Pavilion trial).
In the Pagoda study, which enrolled 634 participants with DME, patients receiving Susvimo with refills every six months achieved comparable vision improvements to those receiving monthly 0.5 mg ranibizumab injections. Notably, approximately 95% of Susvimo-treated patients did not require supplemental anti-VEGF (搜索) injections during the 64-week primary analysis period.
The Pavilion trial, involving 174 participants with diabetic retinopathy (搜索) without center-involved DME, demonstrated that Susvimo refilled every nine months achieved superior DRSS improvements compared to monthly clinical observation. None of the Susvimo-treated patients required additional anti-VEGF (搜索) injections during the 52-week primary analysis period, while 60% in the observation arm needed intervention.
"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, a member of the Roche Group. "We hope to bring this option to people with DME and diabetic retinopathy (搜索) as soon as possible to help maintain their vision and potentially their independence."
Long-Term Efficacy and Safety Data
Updated two-year data from both trials, presented at the recent American Society of Retina Specialists (ASRS) 42nd Annual Meeting, further supported Susvimo's potential in treating diabetic eye diseases. In the Pagoda trial, participants maintained the vision improvements seen at one year (9.8 eye chart letters) through the two-year mark.
The Pavilion study's two-year results showed that 80% of Susvimo participants achieved a two-step or greater improvement on the DRSS from pre-implant baseline at week 100. Participants who received Susvimo from week 64 either maintained or improved their DRSS score from pre-implant baseline.
"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 noted.
Innovative Treatment Approach
Susvimo 100 mg/mL for intravitreal use via ocular implant represents an innovative approach to treating retinal diseases. The device is surgically inserted into the eye during an outpatient procedure and continuously delivers a customized formulation of ranibizumab over time, potentially reducing the treatment burden associated with frequent intravitreal injections.
Current standard treatment for DME typically requires regular intravitreal injections of anti-vascular endothelial growth factor (VEGF (搜索)) agents, which can be burdensome for patients and healthcare systems. Susvimo's extended delivery system could significantly reduce the number of clinic visits and injections needed.
Recent Return to Market
Susvimo was previously approved for treating neovascular (wet) age-related macular degeneration (AMD) in October 2021. However, Genentech voluntarily recalled the product in October 2022 after test results indicated the ocular implant, insertion tool, and initial fill kit failed to perform to the company's standards.
On July 8, 2024, Genentech announced the reintroduction of Susvimo to the US market after the FDA granted a post-approval supplement to the BLA based on component-level updates to the ocular implant and refill needle. The company stated plans to make Susvimo available to US retina specialists for the treatment of wet AMD in the coming weeks.
"It's exciting that Susvimo is coming back," said Arshad Khanani, MD, managing partner and director of clinical research at Sierra Eye Associates. "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."
Addressing Unmet Needs in Diabetic Eye Disease
Diabetic eye diseases represent a significant burden for patients with diabetes. DME is a complication of diabetic retinopathy (搜索) and a leading cause of vision loss among working-age adults. The current treatment paradigm, requiring frequent injections, presents challenges for patient adherence and quality of life.
If approved for these new indications, Susvimo would offer an alternative treatment option that could potentially improve treatment adherence while maintaining vision outcomes comparable to monthly injections. This could represent a significant advancement in the management of diabetic eye diseases, particularly for patients who struggle with the frequency of current treatment regimens.