Ophthotech Corporation has raised $175 million to finance a global phase 3 clinical trial of Fovista, an anti-platelet-derived growth factor used in combination with anti-VEGF therapy for wet AMD.
The multinational phase 3 trial is expected to begin in the third quarter of 2013 and enroll nearly 1,900 patients at more than 200 centers worldwide.
Fovista in combination with Lucentis (ranibizumab injection) demonstrated superior efficacy over Lucentis monotherapy in a randomized, controlled phase 2b study of 449 patients with wet AMD. Patients receiving the combination treatment gained a mean of 10.6 letters on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy (P = 0.019). No significant safety issues were observed for either treatment group.
The financing of the $175 million consists of $125 million from Novo A/S in exchange for royalties on Fovista sales, with the remaining $50 million in the form of a Series C preferred stock financing from Novo A/S and current venture investors in Ophthotech. The royalty and Series C funding is structured in three equal tranches, the first of which has closed.
Ophthotech also announced that it has expanded its management team to accelerate the clinical development of Fovista. David R. Guyer, MD, the company's chairman of the board since its inception, is now the CEO, and Samir Patel, MD, co-founder and current president of Ophthotech, is taking on the additional role of vice chairman of the board. Under the new management structure, Dr. Guyer will direct the company's corporate and financial strategy, while Dr. Patel will focus fully on clinical development.
"Ophthotech is well positioned to bring this important drug rapidly to market, based on the strength of phase 2b results and the proven medical, regulatory and commercial capabilities of its management team," said Henrik Gürtler, CEO of Novo A/S.