EC approves broader use of Novartis’ Lucentis
To treat vision loss from macular edema secondary to retinal vein occlusion
Novartis has won approval for broader use of its eye drug Lucentis (ranibizumab).
The European Commission has approved the drug to treat patients with visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO and central RVO).
Lucentis is already approved in more than 85 countries for the treatment of wet age-related macular degeneration (AMD) and in more than 30 countries for the treatment of visual impairment due to diabetic macular edema (DME).
RVO is a sudden-onset disease that makes it difficult for patients to cope with daily activities such as reading, cooking and driving.
Novartis says Lucentis is the first anti-VEGF therapy licensed for the treatment of both branch- and central-RVO in the EU. In trials it has demonstrated that it improves vision and vision-related quality of life for these patients.
RVO results from a blockage forming in a blood vessel in the retina. In CRVO, the blockage occurs in the main retinal vein at the optic nerve. In BRVO, the blockage occurs in one of the four branches of the main retinal vein. Both CRVO and BRVO can lead to swelling of the macula edema, which is the central portion of the retina responsible for sharp central vision. This swelling is the most common cause of visual impairment in patients with RVO. RVO often leads to increased production of vascular endothelial growth factor (VEGF), which can exacerbate RVO complications including macular edema.
‘This is an important step forward in the management of patients with RVO because the disease is difficult to treat with few available options,’ said Ian Pearce, consultant ophthalmologist at the Royal Liverpool University Hospital in the UK. ‘Laser treatment can provide partial improvement for BRVO patients but many do not regain their vision. Laser treatment for patients with CRVO is not considered effective and prognosis is worse than that for BRVO.’
Genentech and Novartis are the developers of Lucentis. Genentech has the commercial rights to the treatment in the US, where it is also approved for the treatment of macular edema following RVO. Novartis has exclusive rights in the rest of the world.