Topline data following completion of ALTISSIMO trial treatment phase expected in second quarter of 2021.
Graybug Vision has announced the completion of a 12-month treatment phase II trial to treat wet age-related macular degeneration (AMD).
The GB-102 phase 2b ALTISSIMO core trial centered around GB-102, a proprietary microparticle depot formulation of the pan-vascular endothelial growth factor (pan-VEGF) inhibitor, sunitinib malate, developed to be administrated intravitreally twice a year, according to a company news release. GB-102 aims to reduce the need for frequent intravitreal injections by extending the length of treatment to six months or longer.
Fifty-six patients were enrolled in the masked, randomized trial, with 50 patients completing the full 12-month treatment phase. Six patients withdrew prior to finishing the trial due to reasons unrelated to their treatment, according to a company news release.
Fifty-eight percent of the patients who completed treatment were deemed eligible and agreed to continue clinical monitoring in a six-month trail extension, which will analyze further durability of GB-102 on AMD.
Trial data is expected to provide important data regarding the duration of treatment, safety and tolerability of GB-102 in wet AMD, according to Parisa Zamiri, MD, PhD, chief medical officer of Graybug Vision, in a news release.
“The findings of this trial, designed to measure the durability of a twice-per-year dosing, may potentially demonstrate the need for fewer treatments per year,” she said.
Topline data are expected to be announced in the second quarter of this year, and full results presented in the later part of 2021 at a medical conference.