Ophthotech Completes Patient Recruitment of the Second Phase 3 Pivotal Trial of Fovista® Anti-PDGF Therapy in Combination with Lucentis® in Wet Age-Related Macular Degeneration
Ophthotech Corporation (Nasdaq:OPHT) today announced the completion of patient recruitment for its second Phase 3 trial of Fovista® (pegpleranib) in combination with Lucentis® (ranibizumab) for the treatment of wet age-related macular degeneration (AMD). The Company expects to announce initial, topline data from both Phase 3 trials of Fovista® in combination with Lucentis® in the fourth quarter of 2016.
“Completion of patient recruitment in these two large scale Phase 3 clinical trials of Fovista® anti-PDGF therapy in combination with Lucentis® is a significant milestone in the Fovista® Phase 3 pivotal program”
“Completion of patient recruitment in these two large scale Phase 3 clinical trials of Fovista® anti-PDGF therapy in combination with Lucentis® is a significant milestone in the Fovista® Phase 3 pivotal program,” stated David R. Guyer, M.D., Chief Executive Officer and Chairman of the Board of Ophthotech. “We believe that Fovista® administered in combination with anti-VEGF therapy may represent a significant advancement in the treatment of wet AMD, and we look forward to obtaining data from both of these studies.”
“We are excited with the progress of the Phase 3 Fovista® clinical development program and grateful for the diligence and commitment of the participating clinical investigators,” stated Samir Patel, M.D., President and Vice-Chairman of the Board of Ophthotech. “The effects of wet AMD are debilitating and represent a significant unmet need. Completion of recruitment in this study brings us one step closer to our goal of potentially introducing a new class of therapy and improving visual outcome for wet AMD patients.”
The two Phase 3 trials investigating the superiority of Fovista® in combination with Lucentis® compared to Lucentis® monotherapy are identical with respect to the trial design in the first year. Therefore the database from both trials will be locked and analyzed together to optimize pooled analysis of certain relevant endpoints in accordance with the statistical analysis plan…….
read more: http://www.businesswire.com/news/home/20151026006213/en/Ophthotech-Completes-Patient-Recruitment-Phase-3-Pivotal