Roche announced today that the U.S. FDA has approved Susvimo (ranibizumab) 100 mg/mL for the treatment of diabetic retinopathy (DR).According to the press release, Susvimo is the first FDA-approved treatment that provides sustained release and requires only one refill every 9 months.DR Treatment Plan Has Been Proven to Maintain Patients' Vision.

Diabetic retinopathy accounts for approximately 5% of all cases of vision impairment. DR occurs when the blood vessels in the eye are damaged and new blood vessels form, leading to leakage of blood and/or fluid into the retina (the eye structure that transmits visual information to the brain). This causes swelling of the retina and blocks blood supply to certain areas. As the condition progresses, vision gradually deteriorates. According to statistics,Globally, approximately 103 million people are affected by DR, and nearly 5 million people have gone blind as a result.

This FDA approval is mainly based on the positive one-year results from the Pavilion Phase 3 clinical study. The trial is a multicenter, randomized Phase 3 clinical study designed to evaluate Susvimo with monthly clinical monitoring andReceive anti-VEGF injections on demandEfficacy, safety, and pharmacokinetic performance of the treatment in patients. A total of 174 non-proliferative diabetic retinopathy (DR) patients without center-involved diabetic macular edema participated in the study. They were assigned to receive either Susvimo treatment supplemented every 9 months or monthly clinical observation at a ratio of 5:3.

Analysis results show that patients receiving Susvimo treatment every 9 months achieved significant improvement in Diabetic Retinopathy Severity Scale (DRSS).Compared with the control group patients who received anti-VEGF injection treatment as needed based on disease progression, the Susvimo group patients had less severe eye damage caused by diabetes.In addition,No patients in the Susvimo treatment group required additional adjuvant therapy within one year.The safety of the drug in the trial is consistent with the known safety profile.

▲Susvimo Eye Injection Diagram (Image Source: Reference [2])

Susvimo is a ranibizumab monoclonal antibody drug delivery system, a refillable ocular implant that can be implanted in the eye through a one-time outpatient surgery.Susvimo Provides Continuous Ranibizumab Infusion for Patients. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a key role in new blood vessel formation and vascular leakage.

References:

[1] FDA approves Roche’s Susvimo for diabetic retinopathy. Retrieved May 22, 2025 from https://www.globenewswire.com/news-release/2025/05/22/3086882/0/en/FDA-approves-Roche-s-Susvimo-for-diabetic-retinopathy.html

[2] Prescribing Information- Susvimo. Retrieved July 18, 2024 from https://www.gene.com/download/pdf/susvimo_prescribing.pdf

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