Swiss drug giant Novartis has received clearance in Europe to market its eye drug Lucentis for the treatment of macular oedema secondary to retinal vein occlusion, a disease than can cause severe damage to the retina, visual impairment and ultimately blindness.
According to the group, the approval means that Lucentis (ranibizumab) is now the first anti-VEGF therapy licensed for both branch- and central-RVO in the European Union, having shown its ability in clinical trials to improve vision in patients suffering from the condition.
Lucentis, an antibody fragment injected into the eye, is already on the market for wet age-related macular degeneration and for the treatment of visual impairment due to diabetic macular oedema.
Approval of the drug's indication for macular oedema secondary to RVO was based on data from clinical trials showing an early and sustained improvement in vision in patients after six months' of monthly Lucentis injections compared with standard of care.
In one Phase III trial (BRAVO), around 60% of patients given Lucentis gained at least 15 letters of visual acuity at six months compared with 29% of those treated with current care, indicating its potential in clinical practice.
Lucentis' new approval marks "an important step forward in the management of patients with RVO because the disease is difficult to treat with few available options," commented Ian Pearce, consultant ophthalmologist at the Royal Liverpool University Hospital.
Laser treatment can provide some improvement for patients with branch-RVO but many do not regain their vision, and it is not considered effective for patients with central-RVO, he noted, highlighting the need for new therapies to help treat these conditions.
But the drug will be competing with Allergan's Ozurdex, a dexamethasone-releasing biodegradable eye implant approved for branch- and central-RVO in Europe last year.