Intravitreal injections of ICON-1 in eyes with neovascular age-related macular degeneration were found to be safe and well-tolerated in doses up to 300 µg.
The open-label, interventional, dose-escalation phase 1 trial included 18 patients with choroidal neovascularization due to neovascular AMD. Each dose cohort included six patients, with patients receiving a single intravitreal injection of ICON-1 (Iconic Therapeutics) at doses of 60 µg, 150 µg or 300 µg.
“This is the first clinical report of a novel mechanism in the treatment of neovascular AMD, distinct from VEGF inhibition that is the basis for our current standard of care. Overexpression of tissue factor in choroidal neovascular membranes makes this an attractive target, and the use of a mutated factor VIIa immunoglobulin is the first clinical use of immunotherapy for treatment of CNV. Recruiting the body’s natural killer T cells has the potential to cause actual regression of the neovascular tissue, which does not occur to a significant degree with anti-VEGF therapy alone,” John A. Wells III, MD, co-author of the study, told Healio.com/OSN.
Researchers assessed safety, tolerability and biological activity on follow-up visits on days 2, 8, 15, 29 and 57, with additional follow-up visits held at weeks 12 and 24.
At final follow-up, all subjects reported at least one adverse event, but none led to premature discontinuation from the study. One serious adverse event was reported 23 days after a 75-year-old man received a 300 µg dose; he was hospitalized with flu-like symptoms, a sore throat and vague chest symptoms. An investigator concluded that this event was not related to ICON-1. No other serious adverse events were reported by patients.
“If significant regression occurs, potentially better visual outcomes and reduced numbers of injections might result. Easing the treatment burden in the treatment of neovascular AMD is one of the main goals of current research,” Wells said.
The researchers reported ICON-1 was well-tolerated by the patients, and no significant safety events were reported. In the 300 µg dose group, a mean change in best corrected visual acuity of +8 letters was observed at 2 weeks after injection of ICON-1. – by Robert Linnehan
Disclosures: Wells reports he received institutional financial support to conduct the study and advisory board consulting fees from Iconic Therapeutics. Please see the study for all other authors’ relevant financial disclosures.