MAY 08, 2009
Comprehensive Ophthalmology, Retina/Vitreous
Ophthotech Corp. has announced positive results of a phase 1 clinical study evaluating E10030, a novel anti-platelet derived growth factor (anti-PDGF) combined with an anti-vascular endothelial growth factor (anti-VEGF), in wet AMD patients.
"Marked neovascular regression, a first in any study, with an outstanding level of visual gain, is very promising for our patients. My clinical experience with current monotherapy anti-VEGF regimen in wet AMD is consistent with published studies, which show that on average neovascular regression does not occur," said Lawrence J. Singerman, MD, clinical professor at Case Western Reserve University and principle investigator.
The open-label multicenter study assessed the safety, tolerability and pharmacokinetic profile of E10030, used in combination with Lucentis. Most patients, 59 percent, experienced increased visual acuity (three-line gain) at 12 weeks follow-up, and all patients demonstrated significant neovascular regression. E10030 was well tolerated with no evidence of drug-related adverse events. Current standard of care treatment utilizing monotherapy anti-VEGF results in three-line visual gain in approximately one-third of patients and without significant neovascular regression.
The results were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting. E10030 is an aptamer targeting PDGF, 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.