The Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) for intravitreal use via ocular implant for the treatment of patients with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least 2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication.
The Susvimo ocular implant is surgically inserted and provides continuous release of ranibizumab, a VEGF inhibitor. The release of ranibizumab into the vitreous decreases over time as the concentration in the implant decreases with a half-life of approximately 25 weeks. Refills are administered every 24 weeks.
The approval was based on data from the multicenter, randomized, visual assessor-masked, active treatment-controlled phase 3 Archway study (ClinicalTrials.gov Identifier: NCT03677934), which evaluated the efficacy and safety of Susvimo in 415 patients 50 years of age and older with wet AMD. Patients were randomly assigned 3:2 to receive continuous delivery of Susvimo via ocular implant every 24 weeks or ranibizumab 0.5mg via intravitreal injection every 4 weeks.
Results showed that patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections (adjusted mean change from baseline in Best Corrected Visual Acuity score averaged over weeks 36 and 40: 0.2 vs 0.5, respectively). Moreover, 98.4% of patients in the Susvimo arm were able to go 6 months before their first refill; only 1.6% of patients needed supplemental ranibizumab treatment before their first refill.
As for safety, the most common adverse reactions with Susvimo were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%). Susvimo was associated with a 3-fold higher rate of endophthalmitis compared with monthly intravitreal injections of ranibizumab. The product is contraindicated in patients with ocular or periocular infections and patients with active intraocular inflammation.
“Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD,” said Carl Regillo, MD, Chief of Retina Service at Wills Eye Hospital in Philadelphia and an Archway study investigator. “With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule.”
The product is expected to be available in the coming months. Genentech is offering a patient assistance program to eligible patients.
- FDA approves Genentech’s Susvimo, a first-of-its-kind therapeutic approach for wet age-related macular degeneration (AMD). News release. Genentech. Accessed October 22, 2021. https://www.businesswire.com/news/home/20211022005479/en/FDA-Approves-Genentech%E2%80%99s-Susvimo-a-First-of-Its-Kind-Therapeutic-Approach-for-Wet-Age-Related-Macular-Degeneration-AMD.
- Susvimo. Package insert. Genentech; 2021. Accessed October 22, 2021. https://www.gene.com/download/pdf/susvimo_prescribing.pdf.