Santen’s topline results from the Phase I/II study of DE-122 for refractory wet age-related macular degeneration (AMD) 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).
The US-based company focusing solely on ophthalmology presented the results at the 15thAnnual Angiogenesis, Exudation, and Degeneration, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine.
As Santen explaiend, 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.
Furthermore, no serious adverse events were reported.
Victor H. Gonzalez, M.D., study investigator and founder of Valley Retina Institute in McAllen, Texas said that the opportunity remains for new therapies to address this significant unmet need. He added that the study results are very encouraging and support the ongoing clinical development of DE-122 as a potential treatment for patients with wet AMD.