The European Medicines Agency has recommended granting a marketing authorisation for Susvimo (ranibizumab), the first ocular implant of its kind approved in the EU, offering adults with stable neovascular age-related macular degeneration (nAMD) an alternative to frequent intravitreal injections.
Age-related macular degeneration (AMD) is a chronic, progressive disease of the macula — the small area at the centre of the retina responsible for sharp, detailed vision. It is a leading cause of central vision loss among people over the age of 50. AMD exists in two forms: dry AMD, which progresses gradually, and neovascular (wet) AMD, in which abnormal blood vessels grow beneath the retina and leak fluid or blood, causing rapid and severe vision loss. nAMD remains a leading cause of visual impairment in the older population and, if left untreated, can lead to irreversible damage to central vision.
Medicines containing ranibizumab have been authorised in the EU for nAMD since 2007. These are injected intravitreally — directly into the vitreous humour of the eye — typically every four weeks. Over time, the burden of frequent injections, combined with regular specialist visits, can affect treatment compliance. Some patients do not achieve or maintain the vision outcomes seen in clinical trials, partly because of the difficulty of sustaining such a demanding treatment schedule.
Susvimo addresses this problem through a refillable ocular implant that is surgically inserted into the eye and designed to release ranibizumab continuously. The implant is refilled every six months, replacing the need for monthly injections. It is indicated only for patients whose disease is stable after responding to prior intravitreal treatment with a vascular endothelial growth factor (VEGF) inhibitor.
A phase 3, randomised, visual assessor-masked study involving 415 patients with nAMD showed that Susvimo was comparable to intravitreal ranibizumab injections administered every four weeks, maintaining both visual acuity and anatomical outcomes over the study period.
The most common side effects reported with Susvimo were iritis (inflammation of the iris), conjunctival bleb or filtering bleb leak (a small bulge in the conjunctiva, with or without fluid leakage), cataract, vitreous floaters, conjunctival haemorrhage, conjunctival hyperaemia, eye pain, and headache.
The CHMP opinion will now be forwarded to the European Commission for a final decision on EU-wide marketing authorisation. Once granted, pricing and reimbursement will be determined at the level of each member state.
Source: EMA News
