Novartis and Genentech have reported promising results in a second Phase III trial of Lucentis (ranibizumab), a drug that treats a leading cause of blindness, and will be in a position to file for approval of the product next year.
If approved for the condition – known as wet age-related macular degeneration - Lucentis will be the third product to be specifically approved in this use. Novartis’ own photodynamic therapy Visudyne (verteporfin), developed alongside QLT, was the first to reach the market. It was joined last year by Pfizer/EyeTech’s Macugen (pegaptanib), which like Lucentis is a vascular endothelial growth factor (VEGF) receptor blocker.
The latest study of Lucentis, called ANCHOR, found that around 95% of patients treated with the antibody maintained their vision over the course of a year, with a 15 letter or less reduction in standard visual acuity testing. Only 64% of the control group, treated with Visudyne, achieved this result. The study is due to continue for a second year.
AMD is a chronic, progressive disease that results in the loss of central vision. As the disease advances, simple tasks such as reading, writing, recognising faces and driving become difficult, if not impossible. AMD is seen as a growing public health epidemic, with diagnoses for the disease expected to double by 2020, driven by the ageing of the ‘baby boomer’ generation.
Between 6% and 10% of patients with AMD progress to the wet form of the disease, characterised by the growth of abnormal blood vessels. This patient group accounts for more than 90% of the patients with severe vision loss, and of these only 25% are suitable for Visudyne treatment. The latest study involved the full spectrum of wet AMD patients, so rather than cannibalising Visudyne sales, Lucentis should expand the market and is likely to be used alongside Novartis’ older treatment.
Nicholas Franco, president of Novartis Ophthalmics, said: "With Lucentis, we hope to be the only pharmaceutical company to provide wet AMD patients with two effective treatments, Lucentis and Visudyne, with different and potentially complementary modes of action."
Novartis noted that the results of the earlier MARINA study [[25/05/05a]] would be combined with the one-year data from ANCHOR to form the basis of US and European marketing applications, due in early 2006.
Genentech has commercial rights for Lucentis in North America (the USA, Canada and Mexico), while Novartis has retained rights for the rest of the world.
Other companies developing treatments for AMD include: eye care specialist Alcon, which is gearing up to file for approval of its Retaane (anecortave acetate) candidate; Miravant Pharmaceuticals, which has a photodynamic therapy - Photrex (rostaporfin; SnET2) - in Phase III trials; Acuity Pharmaceuticals which has a VEGF inhibitor based on the emerging small interfering RNA (siRNA) technology in Phase II; and Genaera, with Evizon (squalamine lactate) in Phase II.