Retaane “Approvable” For Macular Degeneration; Alcon Plans July Meeting With FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Alcon expects to meet with FDA in July to discuss a May 23 "approvable" letter for its wet age-related macular degeneration agent Retaane (anecortave acetate suspension)
You may also be interested in...
Genentech Lucentis priority review
Genentech's BLA for its wet age-related macular degeneration treatment Lucentis (ranibizumab) is granted a priority review at FDA, giving the VEGF antibody a June 29 user fee goal date. Genentech's submission includes a head-to-head trial with Novartis/QLT's photodynamic therapy Visudyne (verteporfin). Genentech has referred to Lucentis as the first wet AMD treatment to show a clinical benefit over PDT in a head-to-head study setting (1Pharmaceutical Approvals Monthly June 2005, p. 12). In conjunction with the priority review designation, Genentech announced preliminary, two-year data from its Phase III MARINA study showing improvement at two years...
Genentech’s Lucentis BLA Will Not Include Data Supporting Dosing Advantage
FDA's decision to deny Genentech fast-track status for Lucentis (ranibizumab) means that the initial submission for the wet age-related macular degeneration therapy, slated for December, will not include data supporting a dosing advantage
Miravant Photrex confirmatory trial begins
Miravant is initiating a 600-patient confirmatory trial of its macular degeneration therapy Photrex (rostaporfin, SnET2), the firm says March 10. The FDA-requested trial's design, reviewed under a special protocol assessment, will evaluate a range of patients with wet age-related macular degeneration, including both classic and occult lesions" (1Pharmaceutical Approvals Monthly February 2005, p. 16)...