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Graybug Vision reported Tuesday a full-data analysis from the phase 2b ALTISSIMO trial of GB-102 for the treatment of wet AMD.
Graybug Vision reported on Tuesday a full-data analysis from the 18-month phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (AMD).
GB-102 is a proprietary formulation of sunitinib malate that is injected intravitreally, twice a year, according to the company.
The ALTISSIMO trial was conducted as a masked and controlled phase 2b dose-ranging study consisting of two doses of GB-102 — 1 mg and 2 mg — with a single control arm of patients on 2 mg aflibercept, a news release stated.
The trial was administered at 33 study sites across the U.S.
Primary endpoint included median time to first supportive therapy with a VEGF inhibitor.
Secondary endpoints consisted of safety; and pharmacodynamics, which were measured as mean change in BCVA and mean change in central subfield thickness (CST) of the retina, the company reported.
The company also noted the 2020 termination of GB-102 2 mg after an interim safety analysis. The trial was not designed to assess non-inferiority to aflibercept.
ALTISSIMO consisted of two phases; the first included a 12-month treatment phase where patients were dosed at day 1 and month 6, while a control arm received a dosage of aflibercept every other month.
The second phase included a six-month extended observation phase, where patients were tracked without any further treatment to determine the effect duration from their last treatment during the first phase, according to the company.
Those patients who participated in the extended study of ALTISSIMO were voluntary.
However, only patients who completed all trial visits — and did not require any supportive therapy during their visit in month 12 of the first phase — were eligible.
Fifty-eight percent of patients who completed the first phase participated in the extended study, with 11 also participating in the GB-102 1 mg arm, the release stated.
The first phase of the trial was designed so patients could not achieve any longer than its six-month duration.
The extended phases allowed for an additional six months for patients to demonstrate a longer duration, the company stated.
This resulted in 55% of GB-102 1 mg patients receiving treatment for 12 months or longer, all while maintaining visual acuity and central retinal thickness, according to the release.
The injection burden was also reduced by 73% on an annually basis for GB-102 1 mg patients who took part in the extended study.
“(This significant reduction) showed that GB-102 1 mg has the potential to significantly improve compliance compare to the current standard of care,” said Parisa Zamiri, MD, PhD, chief medical officer of Graybug.
To note, this duration of time is the longest ever reached with an intravitreal injection in a randomized, masked, and controlled trial for wet AMD.
As seen in the first phase of the trial, GB-102 1 mg continued to be well-tolerated and sustained a favorable safety profile during the extended phase. No drug-related adverse events or vision-threatening inflammation were reported, the company stated.