EU Advisers Back Susvimo Implant as New Option for Wet Age‑Related Macular Degeneration

Overview

• The EU medicines committee issued a positive opinion recommending marketing authorisation for Susvimo, a ranibizumab product delivered through a surgically implanted device.
• Susvimo contains ranibizumab 100 mg/ml and uses the Contivue ocular implant to release drug continuously and be refilled every 24 weeks.
• Phase 3 trial data reviewed by regulators showed Susvimo maintained visual and anatomical outcomes comparable to monthly intravitreal ranibizumab injections while greatly reducing dosing frequency.
• Regulators say the implant must be placed and managed by ophthalmologists experienced in vitreoretinal surgery, and common side effects include iritis, conjunctival bleb or leak, cataract, floaters, eye redness, eye pain and headache.
• If the European Commission grants final authorisation, each EU country will decide on pricing and reimbursement and clinics will need to train surgeons before patients can access the implant, which could ease long‑term treatment burden for many people with stable nAMD.