We are a biopharmaceutical company specializing in the development of novel therapeutics to treat diseases of the back of the eye, with a focus on developing therapeutics for age-related macular degeneration (AMD).
There is a need for improved management of wet AMD, despite available therapies for this form of the disease. In clinical studies of the current standard of care, anti-VEGF monotherapy, the majority of patients with wet AMD did not achieve significant visual gain as defined by reading three or more lines on the standardized chart for testing vision, and approximately 20% lost additional vision during the first year of treatment.
Fovista® anti-PDGF therapy, our most advanced product candidate, is a PDGF-BB inhibitor with the potential to enhance visual outcomes in patients with wet AMD when used in combination with anti-VEGF therapy. Multiple independent laboratories have demonstrated the importance of PDGF-BB inhibition in combination with VEGF inhibition in pathologic neovascularization, the development of abnormal new blood vessels.
In a large Phase 2b clinical trial of 449 patients with wet AMD, Fovista® 1.5mg in combination with one of the current standard of care anti-VEGF therapies, achieved statistically significant superiority compared to anti-VEGF therapy alone. This enhanced visual benefit, measured by the pre-specified endpoint of mean change in visual acuity at the 24-week time point, represents a 62% comparative benefit from baseline relative to anti-VEGF monotherapy.
A large Phase 3 clinical program of Fovista® in combination with anti-VEGF monotherapy is underway to evaluate the safety and efficacy of Fovista® combination therapy for the treatment of newly diagnosed wet AMD patients compared to current standard of care monotherapy. We expect to have initial, top-line data from our Phase 3 clinical program by the end of 2016. To learn more about Fovista®, please click here.
We are also advancing our second product candidate, Zimura®, an inhibitor of complement factor C5, in both dry and wet AMD. Based on results of our Phase 2a trial, data from a third-party clinical trial and multiple published studies suggesting that the complement pathway plays a significant role in dry AMD, we plan to initiate a Phase 2/3 clinical trial investigating Zimura® for treatment of geographic atrophy, a severe form of dry AMD affecting approximately 8 million patients worldwide. To learn more about Zimura®, please click here.