New data confirm efficacy, safety of ranibizumab

Milan, Italy-New data for ranibizumab (Lucentis, Genentech/Novartis), demonstrate that individualized treatment with the anti-vascular endothelial growth factor (VEGF) agent provides sustained improvement in vision with a low number of injections for patients who have wet age-related macular degeneration (AMD), diabetic macular edema (DME), and visual impairment due to macular edema secondary to retinal vein occlusion (RVO).

Among the data, which were presented at the European Society of Retina Specialists Congress:

In the 1-year REPAIR study, 0.5 mg of ranibizumab administered on an individualized basis in 65 patients with myopic choroidal neovascularization improved the patients’ mean visual acuity by 12 letters after 6 months of treatment. The patients received an average of three injections, with 29% requiring no further treatment beyond the first injection.

In the RESTORE extension study, 240 patients with DME received individualized treatment with ranibizumab according to a regimen consistent with the European Union label. Results showed that patients who were originally treated with ranibizumab received an average of 13.9 injections over 3 years. Nineteen percent to 25% of patients across all study arms did not require any ranibizumab injections during years two and three. An average of 3.7 injections in the second year and 2.7 in the third year were sufficient to maintain fully the mean of seven letters of visual acuity gained in the RESTORE core study.

Data from the retrospective part of the LUMINOUS program, which comprises pooled data from four European registries of nearly 4,500 patients with wet AMD treated with ranibizumab, revealed low incidences of key adverse events at 12 months. Additionally, a low number of injections were observed during the first year. The mean number of injections over 12 months ranged from 4.3 to 5.0 (based on all patients) and 4.7 to 5.5 (based on patients completing 1 year).

“[Ranibizumab] has become the standard of care in wet AMD and has helped to improve vision significantly in a majority of patients with this disease,” said Tim Wright, global head of development, Novartis Pharma. “These new data confirm that an individualized treatment approach can lead to optimal improvements in vision with a low average number of treatments, thus ensuring that patients with retinal diseases are not over- or undertreated. In addition, these data add to the well-characterized safety profile of [ranibizumab].”

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