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news.Ophthotech has announced the completion of patient recruitment of its first Phase 3 trial of Fovista in combination with Lucentis (ranibizumab).
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The Company expects patient recruitment in the second Phase 3 trial investigating Fovista in combination with Lucentis to be completed approximately by the end of the third quarter of 2015.
A third Phase 3 trial, which is investigating Fovista in combination with Eylea (aflibercept) or Avastin (bevacizumab), is recruiting patients as expected, and the Company anticipates the duration of recruitment for this third trial to be roughly similar to that of the first two trials.
The Company’s timing projections for the trials that continue to enroll patients assume that there is no impact on recruitment related to the summer season or the initiation or activation of competing trials.
The Company expects the initial, topline data from both Phase 3 trials of Fovista in combination with Lucentis to be available in 2016, approximately one year after the enrollment of the last patient in the second Phase 3 trial, plus the time needed for database closure and analysis of the initial, topline data.
In addition to being identical with respect to the trial design in the first year, both of these Phase 3 trials are investigating the superiority of Fovista in combination with Lucentis compared to Lucentis monotherapy alone. Therefore, the database from both trials of Fovista in combination with Lucentis will be locked and analyzed together, which will allow for the analysis of multiple relevant endpoints in accordance with the statistical analysis plan.
The Fovista development strategy is to be agnostic with respect to the choice of the anti-VEGF agent administered in combination with Fovista. In the third Fovista Phase 3 trial either Eylea or Avastin is used as the anti-VEGF agent in combination with Fovista versus administration of either Eylea or Avastin alone in the control arm.
The Company’s Fovista Phase 2b trial utilized Lucentis as the only anti-VEGF agent because Eylea was not yet approved for marketing and Avastin’s non-inferiority status compared to Lucentis was not yet established when the Phase 2b trial commenced.
Therefore, in order to gain more experience with Fovista when combined with Avastin or Eylea prior to starting a pivotal trial, the Phase 3 trial of Fovista in combination with Avastin or Eylea started later than the Phase 3 trials utilizing Lucentis as the anti-VEGF agent.
This time period of approximately nine months allowed Ophthotech to complete the assessment of initial preclinical and clinical studies, and ensure compatibility of Eylea or Avastin when administered in combination with Fovista. This pivotal Phase 3 trial investigating Fovista in combination with either Eylea or Avastin as the anti-VEGF agent continues to enroll at the expected rate.
Ophthotech’s key objective and plan is to make Fovista commercially available to physicians for their patients with wet AMD as quickly as possible, assuming a positive data outcome from the Phase 3 program.
As the Company continues to explore various regulatory filing options, the Company believes that the most likely scenario 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 first two Phase 3 trials of Fovista in combination with Lucentis and 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.
"We are excited with the progress of the Fovista Phase 3 pivotal program and reaching our first major recruitment milestone," said David R. Guyer, M.D., Chief Executive Officer and Chairman of the Board of Ophthotech.
"We have focused our resources on obtaining our initial, topline data in 2016. Given the Fast Track status granted by the FDA for Fovista for the treatment of wet AMD, we believe that Fovista administered in combination with anti-VEGF therapy is well positioned to potentially be first to market in this class of novel therapy for wet AMD."