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Ophthalmic Professional

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FDA Approves Genentech’s Susvimo for Diabetic Retinopathy

This is the third approved indication for the ranibizumab injection, which is delivered via the refillable port delivery system.

Ophthalmic Professional May 22, 2025

Clinical Report: FDA Approves Genentech’s Susvimo for Diabetic Retinopathy

Overview

The FDA has approved Genentech’s Susvimo for diabetic retinopathy, marking its third indication. This innovative treatment allows for continuous delivery of ranibizumab, requiring administration only once every nine months.

Background

Diabetic retinopathy (DR) is a leading cause of vision loss among working-age adults, necessitating effective treatment options. Current standard care involves frequent anti-VEGF injections, which can be burdensome for patients. The introduction of Susvimo offers a novel approach to reduce treatment frequency while maintaining therapeutic efficacy.

Data Highlights

{'format': 'structured', 'content': [{'Study': 'PAVILION Study', 'Outcome': '≥2-step DRSS improvement at 52 weeks', 'Susvimo': '80.1%', 'Observation': '9.0%'}]}

Key Findings

  • Susvimo is the first continuous delivery system approved for diabetic retinopathy.
  • Patients treated with Susvimo showed significantly greater improvement in DR severity compared to observation.
  • No patients receiving Susvimo required additional treatment during the first year.
  • The FDA approval was based on results from the phase 3 PAVILION study.
  • Susvimo requires treatment every 9 months, reducing the burden of frequent injections.

Clinical Implications

The approval of Susvimo provides a new treatment option for patients with diabetic retinopathy, potentially improving adherence to therapy. Clinicians should consider this option for patients who have previously responded to anti-VEGF injections, particularly those who may struggle with frequent office visits for injections.

Conclusion

The introduction of Susvimo represents a significant advancement in the management of diabetic retinopathy, offering a less burdensome treatment regimen while maintaining efficacy.

References

  1. Retinal Physician, FDA Approves Susvimo for DR, 2025 -- FDA Approves Genentech’s Susvimo for Diabetic Retinopathy
  2. Retinal Physician, Genentech's Susvimo Drug-delivery Device Approved, 2021 -- Genentech's Susvimo Drug-delivery Device Approved
  3. Retinal Physician, SUBSPECIALTY NEWS: Izervay FDA approval, 2023 -- SUBSPECIALTY NEWS: Izervay FDA approval, ReST committee updates on Syfovre, and more.
  4. PubMed, Diabetic Retinopathy Preferred Practice Pattern® -- Clinical guidance on diabetic retinopathy management
  5. retinal physician — Port Delivery System Sustains nAMD Control Over 5 Years
  6. Diabetic Retinopathy Preferred Practice Pattern® - PubMed
  7. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s008lbl.pdf