Date: 2015-05-11
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Ophthotech (USA - NY)
Product: Fovista®
Action
mechanism: Fovista® is an anti-PDGF aptamer. It is designed to target platelet derived growth factor (PDGF) in combination with anti-VEGF drugs to disrupt the formation of abnormal new blood vessels in wet AMD. Fovista®binds to and inhibits PDGF expression, causing the loss or stripping of pericytes, leaving the endothelial cells unprotected and highly vulnerable to the effects of anti-VEGF therapy. Clinical data have shown that administration of Fovista® 1.5mg in combination with anti-VEGF drugs is likely to inhibit new blood vessel growth in patients with wet AMD more effectively than anti-VEGF monotherapy and may also enhance neovascular regression.
Disease: wet age-related macular degeneration (AMD)
Therapeutic area: Ophtalmological diseases
Country:
Trial
details: 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.
Latest
news: * On May 11, 2015, Ophthotech announced the completion of patient recruitment of its first Phase 3 trial of Fovista® in combination with Lucentis® (ranibizumab). 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®1 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 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®.
