Santen has announced that the topline results from the phase I/II study of DE-122 (carotuximab) for refractory wet age-related macular degeneration (AMD) were presented at the 15th Annual Angiogenesis, Exudation, and Degeneration, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine.

The open-label, dose-escalation, sequential-cohort phase I/II study assessed the safety, tolerability, and bioactivity of a single intravitreal injection of DE-122 at four dose levels in 12 subjects (n=3 per dose) with wet AMD refractory to vascular endothelial growth factor (VEGF) inhibitors. Subjects were followed up to 90 days.

No serious adverse events were reported. The study results also suggest bioactivity of DE-122 in refractory wet AMD patients, as measured by mean change in central retinal subfield thickness (CST) based on the spectral domain optical coherence tomography (SD-OCT).

"Wet AMD continues to be a leading cause of blindness and is responsible for severe loss of vision in most patients. The opportunity remains for new therapies to address this significant unmet need," said Victor H. Gonzalez, M.D., study investigator and founder of Valley Retina Institute in McAllen, Texas. "The study results are very encouraging and support the ongoing clinical development of DE-122 as a potential treatment for patients with wet AMD."

Carotuximab is a novel antibody to endoglin, a protein overexpressed on endothelium essential for angiogenesis and upregulated by anti-VEGFs. DE-122, a novel ophthalmic formulation of carotuximab, is active in preclinical choroidal neovascularization (CNV) models and expected to enhance the effect of anti-VEGF agents used to treat wet AMD. DE-122 is being investigated in a Phase 2a randomized controlled trial (NCT03211234) assessing the efficacy and safety of intravitreal injections in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD.