Ophthotech’s (NASDAQ:OPHT) combination of Fovista (anti-PDGF) and anti-VEGF therapies has triggered expert guardedness on its potential for Phase III success in wet age-related macular degeneration (wAMD).
Despite optimism on the combined MOAs, some experts cited the 30 September failure of Regeneron’s (NASDAQ:REGN) rinucumab (anti-PDGFR-beta antibody) and anti-VEGF Eylea (aflibercept) in a Phase II as foreboding for Ophthotech’s combination, while others remained unconcerned about the translatability of Regeneron’s failure for Ophthotech.
Experts also noted that while Phase IIb (NCT01089517) results with Fovista were impressive, a shift from classic lesion enrollment to all-comers in the Phase III could mitigate the drug’s success chances.
Ophthotech is running three Phase III trials with 12-month primary outcomes, including two comparing Fovista + Roche’s (VTX:ROG) Lucentis (ranibizumab) to Lucentis alone and one comparing Fovista + Roche’s anti-VEGF Avastin (bevacizumab) or Fovista + Eylea to either anti-VEGF alone. The Fovista + Lucentis trials are due to read out by YE16 and the third in 2017.
Analyst sentiment is positive about Phase III success chances given the different MOA to rinucumab and reports noted while the Phase III inclusion of patients with occult lesions – vs classic lesions in the Phase IIb -- could dilute treatment results, broad efficacy is expected across the Phase IIIs.