Regulatory Decision Summary for Susvimo

Clinical efficacy and safety of Susvimo were assessed in a randomized, multicenter, open-label (visual assessor-masked), active-comparator study ARCHWAY in 415 patients with wet AMD. After 40 weeks of treatment, patients treated with Susvimo showed similar visual acuity improvement as patients treated with monthly intravitreal (IVT) injection of ranibizumab. The visual acuity improvement was generally maintained over 48 weeks.

Susvimo may cause serious side effects, such as eye infection/eye inflammation including endophthalmitis, visual acuity reduced, rhegmatogenous retinal detachment, vitreous hemorrhage, conjunctival erosion and conjunctival retraction, device dislocation, and device damage/septum dislodgement. These events can result in severe vision loss or blindness and require immediate and appropriate medical and/or surgical interventions.

Due to the serious side effects associated with Susvimo, Susvimo should be administered only to patients specified in the authorized indication; specifically wet AMD patients who have confirmed response to and require frequent IVT injections (every 8 weeks or more frequently) of a VEGF inhibitor medication in order to maintain visual acuity. Susvimo provides an alternative treatment method with a reduced treatment frequency while maintaining efficacy for the treatment of wet AMD for these patients.

Susvimo is delivered via a novel innovative intraocular PDS. The insertion of the PDS is a surgical procedure. Before implanting the PDS, patients should be fully aware of the risks associated with the implant and the procedures and have also signed the surgical consent form. Patients should be able to follow through appropriately on all eye care instructions provided in order to prevent serious adverse events including endophthalmitis. Patients should also be instructed to immediately report to their ophthalmologist any unexpected discomfort that might arise during the lifetime of the implant (see Susvimo Product Monograph for details).

At this time, the risks associated with long-term use of Susvimo and its PDS cannot be sufficiently assessed. The sponsor has committed to closely monitor the long-term safety of Susvimo and its PDS in the long-term extension study and observational post-authorization safety study as well as conduct enhanced pharmacovigilance.

Based on above, as labelled, the benefits of Susvimo (ranibizumab injection) for the drug component outweigh the risks for the treatment of wet AMD in eligible patients specified in the Indication of Susvimo.

View Susvimo Product Monograph for more information.