Fovista, an aptamer directed against platelet-derived growth factor subunit B (PDGF-B), regulates the cells associated with the walls of newly formed small blood vessels, the neovascular pericytes.
The prospective, controlled study, which randomised 449 patients to evaluate the efficacy and safety of Fovista administered inconjunction with Lucentis monotherapy, met the pre-specified primary efficacy endpoint of mean vision gain..
Patients receiving the combination of Fovista (1.5mg) and Lucentis gained a mean of 10.6 letters of vision on the ETDRS standardised chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy (p=0.019), representing a 62% additional benefit.
As per the study design, the Hochberg procedure was employed to account for multiple dose comparisons.