Graybug Vision announced the last patient visit in its GB-102 phase 2b ALTISSIMO core trial (the 12-month treatment phase) in wet age-related macular degeneration (AMD). ALTISSIMO 12-month topline data are expected to be announced in the second quarter of 2021, with full results to be presented at a medical conference later in the year.
Of the 56 patients enrolled in ALTISSIMO, 50 patients completed the 12-month treatment phase, while the remaining six patients withdrew for reasons unrelated to their treatment. Furthermore, 58 percent of patients who completed their Month 12 visit were eligible and agreed to continue clinical monitoring in a 6-month extension of the trial. The goal of this 6-month extension period is to observe further durability of GB-102 in wet AMD patients.
“We are pleased with the completion of treatment in ALTISSIMO which is expected to provide important data regarding the duration of treatment, safety and tolerability of GB-102 in wet AMD,” Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug Vision, said in a company news release. “Wet AMD is a leading cause of vision loss among the elderly with outcomes adversely affected by the high treatment burden of approved medications which need to be injected up to 12 times per year. 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, and we look forward to sharing the topline results in the second quarter of 2021.”
Graybug’s lead product candidate, GB-102, is a proprietary microparticle depot formulation of the pan-vascular endothelial growth factor (pan-VEGF) inhibitor, sunitinib malate, designed to be administered intravitreally twice per year. GB-102 seeks to reduce the need for frequent intravitreal injections by expanding treatment duration to six months, and potentially longer, thus reducing the burden of current anti-VEGF treatments which require up to 12 injections per year.
About GB-102 Phase 2b Clinical Trial in Wet AMD (ALTISSIMO)
ALTISSIMO comprises a 12-month, multicenter, prospective, masked, randomized trial comparing GB-102 administered every six months to aflibercept administered every 2 months in patients with anti-VEGF-responsive wet AMD, followed by an additional 6-month observational period. The objective of the ALTISSIMO phase 2b core trial is to assess the safety, tolerability, and pharmacodynamic profile of GB-102. The findings will inform the design of Graybug’s pivotal phase 3 clinical trial program in wet AMD expected to initiate in the second half of 2021.