Ophthotech announced the completion of patient recruitment in its phase 3 trial of Fovista (pegpleranib) anti-PDGF therapy, in combination with Eylea (aflibercept) or Avastin (bevacizumab), for the treatment of wet age-related macular degeneration (AMD), according to a company news release. Ophthotech also announced that it has achieved a $30 million enrollment milestone from Novartis Pharma AG as part of the ex-US licensing and commercialization agreement between the two companies focused on the treatment of wet AMD.
The Fovista phase 3 program consists of three clinical trials to evaluate the safety and efficacy of Fovista in combination with multiple anti-VEGF agents for the treatment of wet AMD. The company completed enrollment in its two other phase 3 trials of Fovista in combination with Lucentis (ranibizumab) last year, and expects to announce initial, topline data from these two studies in the fourth quarter of this year.
"We are thankful for the steadfast commitment of the participating clinical investigators and their staff for their diligent effort to complete the enrollment of our phase 3 trials. We are excited by the potential of Fovista to be paired with all anti-VEGF agents to address the growing unmet need for wet AMD patients," Samir C. Patel, MD, president and vice chairman of the board of Ophthotech, said in the news release.
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.
The third and final recruitment milestone from the company's ex-US partner for Fovista, Novartis Pharma AG, was triggered as a result of Ophthotech reaching this patient enrollment goal. To date, Ophthotech has attained $330 million in upfront fees and milestone payments from Novartis. These amounts consist of a $200 million upfront fee upon the execution of the agreement in May 2014 and $130 million in enrollment-based milestones under the agreement. Additionally, Ophthotech is eligible to receive up to an aggregate of $300 million upon achievement of specified regulatory milestones, including marketing approval and reimbursement approval in certain ex-US territories, and ex-US sales milestones of up to $400 million. In addition, Ophthotech is entitled to receive royalties on ex-US Fovista sales.
The $30 million milestone will result in approximately $27 million of revenue to be recorded in the quarter ending June 30, 2016. The remaining $3 million will be deferred and recognized as revenue on a proportional basis through 2018.