New York-based Ophthotech has rounded up a whopping $175 million in financing to cover a pivotal late-stage study of its lead drug for wet age-related macular degeneration (AMD). The biotech signed a deal to share its royalties on Fovista--earlier dubbed E10030--with Novo A/S in exchange for $125 million. And Novo stepped up to lead a $50 million Series C round for the company.
Ophthotech, which was set up by Eyetech veterans, is taking the big step into Phase III after reporting positive results from a Phase IIb study of Fovista last summer. Investigators reported data on the 449 patients recruited for the study, who were split between one arm that received a combination of Fovista and Lucentis and another group that received only Lucentis. The primary endpoint was vision acuity.
The patients receiving a combination of Fovista (1.5 mg) and Lucentis gained a mean average of 10.6 letters of vision on a standardized chart test after 24 weeks of therapy, compared to 6.5 letters for patients receiving Lucentis monotherapy, a 62% added vision benefit. Now the company wants to see if it can safely replicate those results in Phase III.
The company was built on the notion that their aptamer would bind to platelet-derived growth factor subunit B and inhibit the growth of blood vessels needed for the development of wet AMD. Combined with an anti-VEGF drug, they reckoned, this new treatment could provide a one-two punch against wet AMD that could go on to become a new standard of care. Clarus Ventures led the $30 million B round in 2009, joined by SV Life Sciences, Novo A/S and HBM BioVentures.
Along with the financing the biotech announced a reshuffling on the management side of the business. Eyetech founder and Ophthotech Chairman David R. Guyer stepped into the CEO role to handle the money end of the business while company co-founder Samir Patel will focus entirely on the clinical development program.
"We are grateful to our investors for their profound confidence in Ophthotech and Fovista as a potential game-changing therapy that we hope will improve outcomes for millions of people with wet AMD," Guyer said in a statement.
- here's the press release