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
October 26, 2015
– Initial, Topline Data From Both Phase 3 Trials of Fovista® in Combination with Lucentis® Expected to be Available in 4Q 2016 –
NEW YORK–(BUSINESS WIRE)– 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,” 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.
A third Phase 3 trial, which is investigating Fovista® in combination with either Eylea® (aflibercept) or Avastin® (bevacizumab), continues to enroll patients with recruitment on track.
Ophthotech continues to explore and consider various regulatory filing options with the goal of providing Fovista® to physicians for their patients with wet AMD as quickly as possible, assuming favorable trial results from the Phase 3 program. The Company believes that the most likely strategy is to initially submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Fovista® in combination with Lucentis® based on data from the two Phase 3 trials of Fovista® in combination with Lucentis®, and to subsequently submit an amendment to the NDA with data from the Phase 3 trial of Fovista® in combination with Eylea® or Avastin®. Alternatively, the Company may elect to file a supplemental NDA for Fovista® in combination with Eylea® or Avastin® following FDA review of the NDA for Fovista® in combination with Lucentis®.
The FDA granted Fast Track status for Fovista® for the treatment of wet AMD in September 2013. The Company believes Fovista® is the most advanced anti-PDGF agent in development for the treatment of wet AMD and, if approved, is expected to be first to market in this class of novel therapies for wet AMD.
About the Fovista® Phase 3 Program
The Fovista® Phase 3 program consists of three clinical trials to evaluate the safety and efficacy of Fovista® anti-PDGF therapy, which Ophthotech is developing for use in combination with anti-VEGF therapy for the treatment of wet AMD. The Company expects to enroll a total of approximately 1,866 patients in the three trials in more than 225 centers worldwide.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the development of novel therapeutics to treat back of the eye diseases, with a focus on developing innovative therapies for age-related macular degeneration (AMD). Ophthotech’s most advanced product candidate, Fovista® anti-PDGF therapy, is in Phase 3 clinical trials for use in combination with anti-VEGF therapy that represents the current standard of care for the treatment of wet AMD. Ophthotech’s second product candidate, Zimura®, an inhibitor of complement factor C5, is being developed for the treatment of geographic atrophy, a form of dry AMD. For more information, please visit www.ophthotech.com.
Any statements in this press release about Ophthotech’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about Ophthotech’s strategy, future operations and future expectations and plans and prospects for Ophthotech, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, Ophthotech’s forward looking statements include statements about, the timing and progress of the Fovista® Phase 3 clinical program, obtaining initial, topline data from these clinical trials, seeking marketing approval for Fovista® and the related regulatory strategy, the potential of Fovista® as a wet AMD combination therapy, and the potential commercial availability of Fovista®. Such forward-looking statements involve substantial risks and uncertainties that could cause Ophthotech’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory approvals or other actions and other factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that Ophthotech files with the SEC. Any forward-looking statements represent Ophthotech’s views only as of the date of this press release. Ophthotech anticipates that subsequent events and developments will cause its views to change. While Ophthotech may elect to update these forward-looking statements at some point in the future, Ophthotech specifically disclaims any obligation to do so except as required by law.
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Kathy Galante, 212-845-8231
Vice President, Investor Relations and Corporate Communications
Jennifer Devine, 973-442-1555 ext. 102
SmithSolve LLC on behalf of Ophthotech Corporation
Source: Ophthotech Corporation
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