Novartis' Lucentis improves visual acuity in wet AMD, two pivotal Ph III studies find

Switzerland-based drug major Novartis says that data from two Phase III trials of Lucentis (ranibizumab), its therapeutic antibody fragment that targets vascular endothelial growth factor, shows that the agent confers significant benefits when used in the treatment of wet age-related macular degeneration. The company also said that the findings, which are published in the current issue of the New England Journal of Medicine, form the basis of the submission it made in March of this year requesting approval for the compound's use in the European Union. The firm went on to say the product has been approved for the condition in Switzerland and the USA.

MARINA: Lucentis versus sham control

In the MARINA trial the drug, which was originally developed by US biotechnology firm Genentech and licensed to Novartis in 2003 (Marketletters passim), was assessed for safety and efficacy in comparison with a sham control injection in patients with minimally classic or occult subfoveal wet AMD. Two-year results from the program showed that 90% of the Lucentis-treated patients maintained vision, defined as a loss of less than 15 letters on the early diabetic retinopathy study eye-chart, compared with only 53% who achieved this in the control group. In addition, the firm reported that 33% of subjects in the treatment arm showed vision improvement, versus only 4% of those in the control group.