Wet AMD Program
Recent evidence suggests that TF plays an important role in the formation of Choroidal Neovasculature (CNV), the pathologic blood vessels that represent the major feature of wet age-related macular degeneration (wet AMD). Current treatment of wet AMD controls the symptoms and can prevent progression of the disease; however, it does not reverse the CNV process. Targeting TF, found overexpressed in the CNV tissue, could reverse the CNV formation process and ultimately cause the removal of the CNV. The human immunoconjugate, ICON-1, Iconic’s lead compound in wet AMD, is a human fusion immunoprotein designed to selectively antagonize TF and lead to immune-based removal of TF overexpressing tissue. This novel approach to the treatment of wet AMD may reverse symptoms of vision loss and distortion, as well as selectively reduce the CNV, and thus alter the course of the disease.
Iconic has successfully completed a Phase 1 clinical trial of ICON-1 in patients with CNV secondary to AMD (Wet AMD). The multicenter Phase 1 trial evaluated the safety and tolerability of a single intravitreal administration of ICON-1. The study demonstrated that ICON-1 was well tolerated by all patients, and no ocular or systemic safety signals were observed. Evidence of biologic activity included reduced retinal thickness on Optical Coherence Tomography (OCT), angiographic evidence of CNV reduction, and gains in visual acuity.
Phase 2 Clinical Study in Patients with Wet Age-related Macular Degeneration
In February 2015, Iconic initiated a Phase 2 randomized, double-masked, multicenter, active-controlled study to evaluate the safety and biological activity of repeated intravitreal administration of ICON-1 in patients with CNV secondary to AMD (the EMERGE trial). The 6-month study is comparing three treatment arms: ICON-1, ICON-1 plus ranibizumab, and ranibizumab alone as an active comparator. The EMERGE study is fully enrolled and we are not accepting additional patients at this time. Further information on this study is available at www.clinicaltrials.gov (ID# NCT02358889).