Swiss drug giant Novartis has filed Lucentis with European regulators for the treatment of wet age-related macular degeneration, the number one cause of blindness in the elderly.
The drug, which has also been put forward for approval in Switzerland and is under a fast-track review in the US, was developed by biotechnology heavyweight Genentech, and represents a strong potential competitor to Pfizer and OSI Pharmaceuticals’ Macugen (pegaptanib sodium injection), which is already cleared in several countries and received a green light in Europe in February.
Lucentis (ranibizumab) could offer some important advantages over Macugen, as studies indicate that it can actually improve vision as opposed to ‘merely’ halt progression of the disease. “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,” commented Nicholas Franco, Head of Opthalmics at the Swiss firm.
The EU submission is based on efficacy and safety data from two pivotal Phase III trials (MARINA and ANCHOR), which revealed that the agent maintained or improved vision in up to 96% of patients treated, regardless of the lesion type or size or visual acuity of the patient at enrollment. In addition, data from the two-year MARINA study show that drug’s beneficial vision effects are consistent with results recorded at one year.
AMD is estimated to affect over 25 million people worldwide. At present, the market for AMD therapies is valued at around $600 million, with Novartis’ own Visudyne (verteporfin) dominating the sector with sales of around $450 million last year.