US regulators have opened the door to Genentech’s Lucentis for the treatment of wet age-related macular degeneration, causing the biotechnology giant’s shares to close up 2.1% at $81.80 following the news on Friday.
AMD is leading cause of blindness in people over 55 and is estimated to affect over 25 million people worldwide. The global AMD sector is valued at around $600 million, and the approval of Lucentis introduces a third player into the US arena, joining Novartis' photodynamic therapy Visudyne (verteporfin) and Pfizer/OSI Pharmaceuticals' VEFG receptor blocker Macugen (pegaptanib) in the wrangle for market share.
Although the drug will likely be somewhat more expensive than its closest rival Macugen, analysts are expecting it to do very well. Studies indicate that Lucentis could offer some important advantages over Macugen, as Lucentis can actually improve vision as opposed to 'merely' halt progression of the disease. "In my opinion, the Lucentis approval stands out as one of the most important medical developments in ophthalmology during my 25 years in the field because it has the potential to reverse vision loss associated with wet AMD," commented Eugene de Juan, President of the American Society of Retina Specialists.
The 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.
The agent is also under review in Europe, where it was filed by Swiss drug giant Novartis, which holds right to the drug in all other territories except North America, which is owned by Genentech.