Date: 2014-08-05
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Ophthotech (USA - NY)
Product: Fovista®
Action mechanism:
Disease: sub-retinal fibrosis in wet age-related macular degeneration (AMD) patients
Therapeutic area: Ophtalmological diseases
Country:
Trial details:
Latest
news: * On August 5, 2014, Ophthotech Corporation announced the initiation of the first of several planned expansion trials, in addition to the ongoing Fovista® combination therapy Phase 3 clinical program. These expansion trials will investigate the potential role of Fovista® combination therapy in reducing sub-retinal fibrosis, addressing sub-optimal treatment response and reducing treatment burden in wet age-related macular degeneration (AMD) patients receiving anti-vascular endothelial growth factor (anti-VEGF) monotherapy. The first expansion trial is a Phase 2a open-label study investigating the potential role of anti-platelet derived growth factor (anti-PDGF) therapy in combination with anti-VEGF therapy in reducing sub-retinal fibrosis in wet AMD patients. Ophthotech also announced that a subgroup analysis showing a reduction of sub-retinal fibrosis and neovascular growth in patients receiving Fovista® (1.5mg) and Lucentis® in the Company’s Phase 2b trial has been accepted as an oral presentation at this year’s Annual Meeting of the American Academy of Ophthalmology, one of the major medical meetings for retinal physicians. A featured oral presentation entitled, “Dual Antagonism of Platelet Derived Growth Factor (Fovista® 1.5 mg) and Vascular Endothelial Growth Factor (Lucentis® 0.5 mg) Results in Reduced Sub-retinal Fibrosis and Neovascular Growth” is scheduled to be presented on October 21, 2014, at the 2014 American Academy of Ophthalmology meeting being held in Chicago, IL. The ongoing Fovista® Phase 3 program consists of three clinical trials to evaluate the safety and efficacy of Fovista® (anti-PDGF) therapy, which Ophthotech is developing for use in combination with anti-VEGF drugs for the treatment of wet age-related macular degeneration. The Company expects to enroll up to 1,866 patients in the three trials in more than 225 centers worldwide and to have initial, topline data from the Fovista® Phase 3 clinical program available in 2016.
