Ophthotech's Fovista tops Lucentis in wet AMD

Privately-held US biotech firm Ophthotech Corp has announced results from the first clinical trial to show statistically significant superior efficacy for its novel anti-PDGF combination agent Fovista over Lucentis (ranibizumab) monotherapy for the treatment of neovascular age-related macular degeneration (wet AMD).

Blockbuster Lucentis is marketed by Novartis (NOVN: VX) outside of the USA and by fellow Swiss drug major Roche (ROG: SIX) in the USA, bringing in first quarter 2012 sales of around $567 million and $420 million, respectively, for the companies.

In a prospective, randomized, controlled Phase IIb clinical trial of 449 patients with wet AMD, Ophthotech’s Fovista anti-PDGF (1.5mg), administered in combination with Lucentis anti-VEGF therapy, met the pre-specified primary efficacy endpoint of mean vision gain. Patients receiving the combination of Fovista anti-PDGF (1.5mg) and Lucentis gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy (p=0.019), representing a 62% additional benefit. No significant safety issues were observed for either treatment group in the trial.