Genentech yesterday revealed that it has been denied fast-track status for its eye drug Lucentis (ranibizumab), which would have permitted it a rolling submission. However, the US biotechnology company stressed that “the US Food and Drug Administration’s decision will not affect the timing for submission in December or the potential to obtain priority review for Lucentis.”
Alongside this planned filing in December, Genentech has also said it plans to launch a Phase IIIb study of Lucentis in patients with a condition known as wet age-related macular degeneration before the end of 2005 as part of a bid to provide more information about the drug’s safety profile. One-year Phase III data from the MARINA study presented at the annual meeting of the American Society of Retina Specialists in July showed Lucentis improved vision in patients with wet AMD [[19/07/05h]], [[25/05/05a]]. Side effects, says the firm, were mild to moderate and included conjunctival hemorrhage, eye pain and vitreous floaters.
The Phase IIIb SAILOR (Safety Assessment of Intravitreal Lucentis for AMD) study is being designed to evaluate the safety of two different doses (0.3 mg and 0.5 mg) of Lucentis in a broad wet AMD population. Patients will receive Lucentis once a month for three months with criteria-based re-treatment options. The study will be conducted at more than 100 sites in the USA and enroll approximately 5,000 patients.
Lucentis is being developed by Genentech and Novartis.