The European Medicines Agency has recommended granting a marketing authorisation in the European Union for Susvimo (ranibizumab) to treat adults with neovascular (wet) age-related macular degeneration (nAMD).
It is for use only in combination with a refillable implant surgically inserted into the eye in people whose disease is stable after responding to intravitreal treatment with a vascular endothelial growth factor (VEGF) inhibitor medicine.
AMD is a chronic, progressive disease of the macula and a leading cause of central vision loss among people over 50. nAMD is a form of advanced AMD that, if left untreated, causes rapid and severe loss of vision and remains a leading cause of visual impairment in the older population.
Medicines containing ranibizumab have been authorised in the EU for the treatment of nAMD since 2007: they are injected intravitreally (into the vitreous humour, the jelly-like fluid in the eye), usually every four weeks.
Such injections, accompanied by regular specialist visits, can be a burden over time, possibly affecting treatment compliance and contributing to some patients not achieving or maintaining vision outcomes comparable to those seen in ranibizumab clinical trials.
Susvimo is delivered via an ocular implant, the first of this kind approved in the EU, which is designed to release ranibizumab over time and is refilled every six months.
Susvimo represents a new treatment option for patients with stable nAMD, offering an alternative to frequent intravitreal injections and potentially easing treatment burden for patients, carers and healthcare systems.
A phase 3, randomised, visual assessor-masked, active comparator study involving 415 patients with nAMD showed that Susvimo was comparable to intravitreal ranibizumab injections administered every four weeks, leading to maintenance of visual and anatomical outcomes.
The most common side effects were iritis (inflammation of the iris), conjunctival bleb/filtering bleb leak (a small bulge in the conjunctiva, with or without fluid leaking), cataract, vitreous floaters, conjunctival haemorrhage, conjunctival hyperaemia, eye pain and headache.
The opinion adopted by the EMA's Committee for Medicinal Products for Human Use (CHMP) is an intermediary step on Susvimo’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.
Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role or use of this medicine in the context of the national health system of that country.
Susvimo is made by Genentech, a member of the Roche Group.
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