Ophthotech has reported positive results from a Phase IIb study of anti-PDGF combination agent Fovista, which demonstrated statistically significant superior efficacy over Lucentis (ranibizumab) monotherapy for the treatment of wet AMD.
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 fully masked study randomised 449 patients to evaluate the efficacy and safety of Fovista administered in conjunction with Lucentis monotherapy.
Patients were given one of the following treatment regimens administered every four weeks for 24 weeks: Fovista 0.3mg in combination with Lucentis 0.5mg, Fovista 1.5mg in combination with Lucentis 0.5mg or sham in combination with Lucentis 0.5 mg.
The prospective, randomised, controlled study 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.