Novartis’ Lucentis has received its first green light in Europe for the treatment of wet age-related macular degeneration, the number one cause of blindness in the elderly, after regulators in Switzerland gave it the all clear.
Lucentis (ranibizumab) is looking to be an exciting new product in the AMD arena. Regulatory submissions for the drug throughout Europe are based on efficacy and safety data from two pivotal Phase III trials (MARINA and ANCHOR), which revealed that the agent maintained or, importantly, 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 Lucentis’ beneficial vision effects are consistent with results recorded at one year.
Lucentis, which is sold in the US by Genentech and is yet to be cleared in the European Union, is likely to be a hot contender for market leadership on both sides of the Atlantic. Although will probably be somewhat more expensive than its closest rival, Pfizer’ and OSI Pharmaceuticals’ Macugen (pegaptanib sodium injection), which received a green light in Europe in February, analysts are expecting it to do very well, because Lucentis has been shown to actually improve vision as opposed to 'merely' halt progression of the disease.
“Lucentis is redefining the treatment standards as the first approved drug for wet AMD patients that has been shown to improve vision and return the ability to do life-affirming everyday activities such as reading,” said Nicholas Franco, Head of Novartis Ophthalmics.
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.
But there are a stream other drugs for wet AMD coming through trials which could soon raise competition in the marketplace. These 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.