Novartis has submitted Lucentis (ranibizumab) for European Union approval for the treatment of neovascular age-related macular degeneration (wet AMD), which is the leading cause of blindness in people over age 60 in the western world.
The European submission, done under the centralised procedure, is the latest in a series aimed at obtaining approvals for Lucentis worldwide. Novartis also submitted Lucentis for regulatory approval in Switzerland in February, informs the company release.
"Lucentis is the first agent to improve vision in patients with wet AMD, setting a new efficacy standard for the treatment of patients with this debilitating disease. We look forward to working closely with regulatory authorities to ensure the availability of Lucentis to patients as quickly as possible," said Nicholas Franco, global head of Novartis Ophthalmics.
The EU submission follows positive one-year clinical data on the efficacy and safety of Lucentis from two pivotal phase III trials (MARINA and ANCHOR) that demonstrated the ability of Lucentis to maintain or improve vision in nearly all patients treated. In both of the pivotal phase III trials, Lucentis was shown to maintain or improve vision in up to 96% of patients treated, regardless of baseline lesion type, lesion size or baseline visual acuity of the patient.
In addition, the recently unmasked two-year efficacy and safety data from the MARINA study are consistent with results observed at one year, showing continued Lucentis treatment sustained the beneficial vision effects achieved during the first year of treatment, while the vision of patients in the sham-control group continued to decline over time.
Lucentis works by inhibiting the growth of abnormal new blood vessels as well as leakage under the macula which lead to wet AMD disease progression and subsequent vision loss.
AMD is estimated to affect over 25 million people worldwide. It is caused by growth of abnormal blood vessels also known as choroidal neovascularization (CNV) or ocular angiogenesis under the macula, the part of the retina that is responsible for central vision, required for activities such as reading, recognizing faces and driving. These vessels leak fluid and blood, causing the development of scar tissue that destroys the macula, leading to the loss of central vision over a period of months to years.
Lucentis (ranibizumab) is a humanised monoclonal antibody fragment designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis (the formation of and leakage from new blood vessels).
Lucentis is being developed by Genentech and the Novartis Ophthalmics' business unit. Genentech retains commercial rights for Lucentis in the United States and Canada. Novartis has exclusive commercialization rights for the rest of the world.