A refillable ocular implant that could reduce treatment frequency for adults with stable neovascular (wet) age-related macular degeneration (nAMD) moved closer to approval in the EU after the European Medicines Agency’s Committee for Medicinal Products for Human Use backed Susvimo (ranibizumab, Roche Registration GmbH). The treatment is intended for patients whose disease has stabilized after responding to prior intravitreal vascular endothelial growth factor (VEGF) inhibitor therapy.

The implant is refilled every 24 weeks, offering an alternative to monthly intravitreal injections with standard ranibizumab treatment. If approved by the European Commission, it would become the first refillable ocular implant of its kind authorized in the EU for nAMD.

Drug and Delivery 

Susvimo provides continuous intravitreal delivery of ranibizumab at a 100-mg/mL concentration via the Contivue ocular implant. Ranibizumab is a recombinant humanized monoclonal antibody fragment that selectively binds and neutralizes VEGF-A, helping suppress abnormal blood vessel growth and vascular leakage associated with nAMD.

The Contivue system is a permanent, refillable ocular implant that continuously releases ranibizumab into the vitreous. The implant reservoir can be refilled repeatedly through a self-sealing septum via clinic-based procedures performed every 24 weeks. Administration must be performed by ophthalmologists experienced in vitreoretinal surgery and trained in the implant procedure.

Clinical Evidence 

The recommendation is based on data from the phase 3 Archway trial. The study enrolled 415 patients who received either the implant with ranibizumab or monthly ranibizumab injections. Participants were adults with nAMD who had shown both visual and anatomic response to prior anti-VEGF treatment.

Patients showed good baseline vision, with mean best-corrected visual acuity of 74.4 letters in the implant group and 75.5 letters in the monthly injection group, equivalent to approximately 20/32 Snellen vision.

Long-term data showed that at 2 years, the implant remained noninferior to monthly ranibizumab, and 94.6%-98.4% of implant-treated patients required no supplemental ranibizumab during each 24-week refill interval. 

Patients in the implant group experienced a temporary vision drop of approximately one line after implant surgery, but vision returned to baseline by week 8. The most commonly reported complications included cataract, conjunctival bleb formation, and vitreous hemorrhage. Endophthalmitis occurred in four implant patients and one monthly ranibizumab patient, with one implant patient experiencing irreversible vision loss. Most adverse events occurred within a month of implantation and were generally manageable.

Clinical Implications 

nAMD affects approximately 1.7 million people in the EU and represents a leading cause of blindness in individuals older than 60 years. The condition develops when abnormal blood vessels grow under the macula, causing swelling, bleeding, or fibrosis that can lead to rapid and severe vision loss without treatment. 

For clinicians, the main appeal of Susvimo is the potential to reduce treatment burden in carefully selected patients with stable disease. But that convenience comes with tradeoffs, including surgical implantation and the risk for device-related complications. In studies, patient preference strongly favored the implant system, with 93.2% of implant-treated patients preferring ranibizumab delivery via the device compared to intravitreal injections. 

The approved indication, dosing recommendations, and prescribing information will be detailed in the Summary of Product Characteristics, which will be published by the EMA if the European Commission grants marketing authorization.