First patient enrolled in Phase II clinical trial of E10030 for treatment of wet age-related AMD

Apr 26 2010

Ophthotech Corp. ("Ophthotech"), a privately held biopharmaceutical company focused on developing ophthalmic therapies for back-of-the-eye diseases, today announced that the first patient has been enrolled in its Phase II randomized, controlled clinical trial of E10030, an anti-PDGF aptamer, in combination with Lucentis® for the treatment of wet age-related macular degeneration (AMD).  

The Phase II trial will assess the efficacy and safety of the combination treatment regimen with approximately 444 patients enrolled at sites in the U.S., Europe and Latin America. In a Phase I clinical study, 59 percent of patients treated with E10030 and Lucentis, an anti-VEGF agent, gained significant vision (3-line gain or better) 12 weeks after the start of therapy.  Notably, there was a mean decrease of 86% in the area of choroidal neovascularization (CNV) at 12 weeks.  In comparison, current standard of care utilizing monotherapy anti-VEGF treatment does not induce significant neovascular regression and results in 3-line or better visual gain in approximately one third of patients.

"With current standard of care, the majority of wet AMD patients do not achieve significant visual gain nor neovascular regression," said Samir Patel, MD, president and CEO of Ophthotech. "Combination therapy with E10030 demonstrates a significant advancement in the treatment of wet AMD.  The magnitude of neovascular regression noted in this Phase 1 study appears to be associated with a significant visual gain in the majority of these patients after only 12 weeks, a result not seen with anti-VEGF treatment alone."

Wet AMD is characterized by the abnormal growth of blood vessels (neovascularization) beneath the retina, which leak blood and fluid and can cause permanent damage to cells in the center of the retina (the macula).  This form of AMD is the most severe form of the disease, and often leads to permanent vision loss.

E10030 is an aptamer targeting PDGF-B, a key molecule involved in the recruitment and maturation of pericytes. Pericytes in neovascular tissue have been shown to be protective and play a major role in anti-VEGF treatment resistance. E10030 strips the pericytes from the neovascular tissue rendering it highly sensitive to an anti-VEGF attack.