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news.Novartis has received the European Commission's (EC) approval for a new indication of Lucentis (ranibizumab) as a treatment for the patients who are suffering from visual impairment associated with macular edema secondary to retinal vein occlusion (branch RVO (BRVO) and central RVO (CRVO)).
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Developed by Genentech and Novartis, Lucentis is an antibody fragment that is injected into the eye and acts by neutralizing VEGF.
The EC’s approval was given on the basis of the results from BRAVO and CRUISE Phase III studies in BRVO and CRVO patients.
The data from the studies demonstrated improved vision in patients at six months with monthly Lucentis treatment as compared with standard of care, and visual acuity gains were maintained from months seven through 12 with as-needed dosing of Lucentis.
Novartis Pharmaceuticals Division head David Epstein 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.
"We are very pleased that another group of patients with debilitating vision loss has access to an effective licensed therapy," Epstein said.