Swiss drug maker Novartis AG (NVS: Quote) on Wednesday said that new data for ranibizumab, traded as Lucentis, showed long-term efficacy and safety of the drug and also the benefits of individualized treatment.
Novartis said the individualized treatment with Lucentis, the only anti-VEGF therapy licensed across three ocular indications, provides sustained improvement in vision with a low number of injections.
Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A or VEGF-A. The drug is licensed for the treatment of wet age-related macular degeneration or AMD, and visual impairment due to diabetic macular edema or DME, among others.
According to the company, the data also showed that an average of three Lucentis injections improve visual acuity in patients with myopic choroidal neovascularization secondary to pathological myopia. Lucentis is currently not approved to treat this condition. Novartis said it will submit for regulatory approval in this indication in the European Union in the third quarter and in Japan by the end of 2012.
Lucentis was developed by Novartis and Genentech, a member of the Roche Group (RHHBY.PK). Genentech has the commercial rights to Lucentis in the United States, while Novartis has exclusive rights in the rest of the world.
Tim Wright, Global Head of Development, Novartis Pharma, said, "Lucentis has become the standard of care in wet AMD and has helped to significantly improve vision in a majority of patients with this disease. 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 under-treated. In addition, these data add to the well-characterized safety profile of Lucentis."
In the REPAIR study, the company explored the efficacy and safety profile of 0.5 mg Lucentis administered on an individualized basis in patients with myopic CNV. The data showed that Lucentis therapy leads to improvement in visual acuity in patients with this condition. Currently, photodynamic therapy with Visudyne (verteporfin) is the only approved medical treatment for this condition.
In the RESTORE extension study, 240 patients with diabetic macular edema received individualized treatment with Lucentis according to a regimen consistent with the European Union label. The safety profile was consistent with previous studies conducted in other indications.
Commenting on the RESTORE study, Professor Francesco Bandello said, "The results of this study show that individualized treatment with Lucentis can lead to a significant improvement in vision and that these improvements are sustained in the long term. It is important that we explore how these insights apply to real-world clinical practice to ensure that we are providing the best possible care for our patients."
The company highlights Lucentis study at the 12th European Society of Retina Specialists (EURETINA) Congress in Milan, Italy.
Novartis shares closed Tuesday's trading at $58.53, down $0.48 or 0.81 percent on the NYSE.
| || |
| To receive FREE breaking news email alerts for Novartis AG and others in your portfolio|
by RTT Staff Writer
For comments and feedback: email@example.com