Ophthotech has completed patient recruitment in its first Phase III trial of Fovista in combination with anti-VEGF agent Lucentis (ranibizumab) in wet age-related macular degeneration (AMD) programme.
The Fovista Phase III programme includes three clinical trials to assess the safety and efficacy of Ophthotech’s Fovista anti-PDGF therapy in combination with anti-VEGF therapy for the treatment of wet AMD.
Nearly 1,866 patients are expected to be enrolled in the three trials in more than 225 centres across the globe.
In the second Phase III trial investigating Fovista in combination with Lucentis, the company expects patient recruitment to be completed by the end of third quarter of this year.
Under the third Phase III trial, Fovista will be evaluated in combination with Eylea (aflibercept) or Avastin (bevacizumab) and the duration of recruitment may be similar to that of the first two trials.
The company hopes to initially submit a new drug application (NDA) to the US Food and Drug Administration (FDA) for Fovista in combination with Lucentis based on data from the first two Phase III trials.
Subsequently, an amendment to the NDA will be submitted with data from the Phase III trial of Fovista in combination with Eylea or Avastin.
Ophthotech may also opt 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.
Ophthotech chief executive officer and board chairman Dr David R. Guyer said: "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.
"We have focused our resources on obtaining our initial, topline data in 2016."
Image: A fundus photo showing intermediate age-related macular degeneration. Photo: National Eye Institute, National Institutes of
Health.
