Novartis eye drug wins wider European licence
pharmafile | June 6, 2011 | News story | Sales and Marketing |Â Â Lucentis, NovartisÂ
Novartis’ Lucentis has been approved in Europe to treat people suffering from vision loss due to macular oedema secondary to RVO.
Retinal vein occlusion (RVO) is a sudden-onset disease where patients suffer from visual impairment and associated difficulties in daily activities such as reading, cooking and driving.
The European Commission approved Lucentis (ranibizumab) to treat visual impairment due to macular edema secondary to branch- and central-RVO, making it the first anti-VEGF drug to gain this licence.
David Epstein, Division Head of Novartis Pharmaceuticals, said: “Lucentis has proven to be an important therapy for people with difficult-to-treat eye conditions, including wet age-related macular degeneration and patients with vision loss due to diabetic macular edema.
“Lucentis is the first anti-VEGF therapy available for patients with both BRVO and CRVO. We are very pleased that another group of patients with debilitating vision loss has access to an effective licensed therapy.”
The approval was based on data from two pivotal Phase III studies, BRAVO in branch-RVO (BRVO) patients and CRUISE in central-RVO (CRVO) patients.
The trials showed early and sustained improvement in vision in patients at six months with monthly Lucentis injections compared with standard of care, and visual acuity gains were maintained from months seven through 12 with as-needed dosing of Lucentis.
For BRVO patients the current standard of care is laser treatment, which may provide gradual and partial improvements in visual acuity. Laser therapy is not indicated for patients with macular edema in CRVO, for whom observation is the usual course of action.
Safety data from the BRAVO and CRUISE trials were similar to previous studies with Lucentis in patients with wet AMD and visual impairment due to DME, and no new adverse events were reported.
At six months the most common ocular adverse events that occurred in the Lucentis-treated patients included conjunctival hemorrhage (48%) and eye pain (17%). In the BRAVO trial, there was one case of endophthalmitis, two arterial thrombo-embolic events, fatal hemorrhagic stroke and non-fatal myocardial infarction. One case of non-fatal myocardial infarction was reported in the placebo group.
In the CRUISE trial, systemic safety events included one case of either myocardial infarction or acute coronary syndrome in each of the three groups. There were no cerebrovascular accidents or deaths.
Lucentis is already approved to treat patients with wet age related macular degeneration and patients with vision loss due to diabetic macular oedema.
Dominic Tyer
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