Genentech has filed for approval of its Lucentis (ranibuzumab) drug for age-related macular degeneration, one of the most common causes of blindness, in the USA.
The biotechnology bellwether is asking for approval to market Lucentis for neovascular or wet AMD, and also wants the US Food and Drug Administration to review the application under its fast-track system, which would take around six months. If the FDA agrees, Lucentis could be on the market in early July.
Genentech has commercial rights for Lucentis in North America (the USA, Canada and Mexico), while Novartis has rights for the rest of the world.
If it is given a green light, Lucentis will be the third product to be specifically approved for 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/OSI Pharmaceuticals’ Macugen (pegaptanib) which, like Lucentis, is a vascular endothelial growth factor (VEGF) receptor blocker. OSI acquired Macugen along with Eyetech Pharmaceuticals last November.
But analysts expect Lucentis to do well as it is backed by clinical data showing that it can improve vision in AMD patients. To date, testing of Macugen and Visudyne has only shown that they can reduce vision loss, so Lucentis is expected to make rapid gains if it reaches the market.
At present, the market for AMD therapies is valued at around $600 million, with Visudyne dominating the sector with sales of around $450 million last year.
Meanwhile, there are a series of other drugs for wet AMD coming through trials, and off-label use of Genentech's cancer drug Avastin (bevacizumab) could also raise competition in the marketplace.
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.