This article is more than 5 years old. Information may no longer be current.
OSPREY trial reports non-inferior results of RTH258 in treatment of wet AMD
Click Here to Manage Email Alerts
DENVER — Repeat doses of RTH258 may effectively treat neovascular age-related macular degeneration, according to a presentation here at the Association for Research in Vision and Ophthalmology annual meeting.
Lawrence J. Singerman , MD , and colleagues conducted the OSPREY trial, a randomized, double-masked, active-controlled study of 89 patients with AMD to evaluate the safety and efficacy of repeat doses of 6 mg of RTH258 (Alcon) vs. 2 mg of Eylea (aflibercept, Regeneron) over 56 weeks.
“As compared to other biologics and other antibodies, the novel design of these stable single-chain antibody fragments may allow better intraocular penetration in relevant tissues, specifically the retina; more drug product per dose delivered; better formulation options, including potential sustained release; and lower systemic exposure,” Singerman said.
In the first part of the study, the two arms had identical dosing of two 8-week treatments. At week 32, the second part of the study included the RTH258 patients being treated every 12 weeks regardless of disease activity. Rescue treatments for both arms were allowed at each monthly visit.
After both parts of the study, RTH258-treated patients showed visual acuity gains that were non-inferior to aflibercept, despite a greater number of rescue treatments in the aflibercept arm.
Approximately 50% of RTH258 patients were successfully maintained with dosing every 12 weeks.
A low rate of adverse events was recorded in both arms.
Based on these results, the sponsor has initiated two global phase 3 studies, with the OSPREY trial incorporated into the design, Singerman said. - by Kristie L. Kahl
Disclosure: Singerman reports he received research support from Alcon Laboratories.