Date: 2014-09-16
Type of information: Presentation of results at a congress
phase: 2b
Announcement: presentation of results at the American Academy of Ophthalmology 2014 Annual Meeting in Chicago, Illinois
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 September 16, 2014, Ophthotech Corporation announced that a subgroup analysis assessing the development and progression of sub-retinal fibrosis in the Company\'s Phase 2b trial comparing Fovista® (1.5mg) combination therapy with Lucentis® (0.5mg) versus Lucentis® (0.5mg) monotherapy will be presented at the American Academy of Ophthalmology 2014 Annual Meeting in Chicago, Illinois.
“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” (Abstract PA092) : The purpose of the retrospective analysis was to assess the evolution and severity of sub-retinal fibrosis in eyes with visual loss (n=70) treated with either the combination Fovista® (1.5 mg) and Lucentis® (0.5mg) or monotherapy Lucentis® (0.5mg). Certified and independent readers masked to drug and treatment regimen assessed the evolution and/or progression of fibrosis. Retinal images were graded on a 0 to 4 categorical scale of increasing severity of sub-retinal fibrosis.
The mean change in severity of sub-retinal fibrosis from baseline to the conclusion of the study at 24 weeks was 0.97 vs. 2.0 (P = 0.003), favoring the Fovista® (1.5mg) combination therapy group. At 24 weeks, approximately twice the number of patients on standard of care anti-VEGF monotherapy (54%) were noted to have progression of sub-retinal fibrosis compared to the Fovista® (1.5mg) combination therapy group (27%). In eyes without any sub-retinal fibrosis at baseline, sub-retinal fibrosis developed in 10% of patients receiving Fovista® (1.5mg) combination therapy group compared to 51% in the monotherapy Lucentis® group.
