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news.The FDA has granted Genentech priority review for its experimental eye drug Lucentis, aimed at the treatment of neovascular wet age-related macular degeneration.
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Priority review is granted to products that are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. The FDA has six months from the submission date, or by the end of June 2006, to take action on the filing as Genentech’s application was received in December 2005.
New preliminary two-year data from Genentech’s phase III study has shown that the improvement previously seen in patients treated with Lucentis at year one was maintained at year two as measured by visual acuity endpoints, while there was further deterioration of vision among patients in the control group.
The difference between mean visual acuity in the Lucentis arms and the control arm increased at year two compared to year one. At least 90% of patients treated with Lucentis maintained or improved vision compared to approximately 53% of those treated in the control arm at year two.
Age-related macular degeneration (AMD) is a major cause of painless central visual loss and is the leading cause of blindness for people over the age of 60. The National Eye Institute estimates that there are 1.7 million people with AMD in the US alone and that this prevalence will grow to 2.95 million by 2020.