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South San Francisco, CA?Genentech Inc.'s ranibizumab (Lucentis), a much-anticipated potential treatment for wet age-related macular degeneration (AMD), has received priority review status from the FDA as part of its Biologics License Application filing.
South San Francisco, CA-Genentech Inc.'s ranibizumab (Lucentis), a much-anticipated potential treatment for wet age-related macular degeneration (AMD), has received priority review status from the FDA as part of its Biologics License Application filing.
The priority review is granted to products considered to offer potentially significant therapeutic advances over existing therapies. The FDA must take action on the filing by June 30.
In addition, the company announced that preliminary 2-year data from the phase III MARINA (Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab In the treatment of Neovascular AMD) study showed that the improvement seen at year 1 in patients treated with ranibizumab was maintained at year 2, as measured by visual acuity endpoints. By comparison, patients in the control group experienced further deterioration of vision.
Common side effects-which were consistent with year-1 safety results-were mild to moderate and included conjunctival hemorrhage, increased IOP, and vitreous floaters. Serious ocular adverse events in the MARINA study that occurred more frequently in the ranibizumab-treated arms were uncommon, but included endophthalmitis (cumulative 1.3% or less over 2 years) and intraocular inflammation (cumulative 1.7% or less over 2 years).
The FDA submission was based on 1-year clinical efficacy and safety data from two pivotal phase III trials, ANCHOR and MARINA, as well as 1-year clinical data from the phase I/II FOCUS trial.
Genentech will submit 2-year data from the phase III MARINA study to the FDA, and those data will be presented during the annual meeting of the Association for Research in Vision and Ophthalmology in Fort Lauderdale, FL.