Graybug Vision has announced positive topline results for the ADAGIO study, a phase 1/2a study of intravitreal GB-102 (sunitinib malate) in patients with wet AMD. Overall, 88% and 68% of evaluable patients were maintained only on a single dose of GB-102 at 3 and 6 months, respectively.

GB-102 is a depot formulation of sunitinib malate intended for intravitreal (IVT) injection. Sunitinib malate is small-molecule receptor tyrosine kinase inhibitor that is an inhibitor of VEGFR-1, -2, and -3, receptors known to play an influential role in the development and progression of wet AMD.

ADAGIO met the primary endpoints of safety and tolerability without dose-limiting toxicities, drug-related serious adverse events, or inflammation. Secondary outcomes demonstrated evidence of stability and maintenance of visual acuity and central retinal thickness that was durable over at least 6 months as measured by eye chart readings and optical coherence tomography (OCT). The OCT measurements showed statistically significant maintenance of reduction in the central subfield thickness at all monthly visits compared to historical pre-GB-102 measures. Rescue treatment was available for those patients who met criteria.

“We are very encouraged with results obtained from our clinical study of GB-102,” said Jerry Cagle, PhD, acting CEO of Graybug Vision, in a news release. “In our ADAGIO study, GB-102 demonstrated safety and efficacy, with a duration of effect reaching 6-8 months from a single intravitreal injection."

The ADAGIO clinical trial was an open-label, single-dose study that enrolled 32 patients from 8 centers located in the United States. Patients enrolled in the study were previously treated with at least 3 prior intravitreal injections of any anti-VEGF agent current standard of care treatment and had to demonstrate a response to anti-VEGF treatment.