Graybug Vision Begins Phase I/II Trial for Candidate in Wet AMD

September 22, 2017: By Jon Swedien

GraybugGraybug Vision has begun dosing patients in a Phase I/II clinical trial for GB-102, its lead product candidate for wet age-related macular degeneration (AMD), the Redwood City, California, company announced Sept. 19.

GB-102 is a novel intravitreal (IVT) injectable depot formulation of sunitinib malate, a tyrosine kinase inhibitor that blocks multiple angiogenesis pathways. GB-102 has the potential to be a twice annual treatment for wet AMD, Graybug said.

The two-part study—ADAGIO—will evaluate wet AMD patients currently being treated with available IVT anti-VEGF agents who are then switched over to treatment with GB-102 alone, Graybug said.

Part one is a multicenter, open-label, single IVT injection study of up to four dose levels of GB-102 administered in ascending dosing cohorts, Graybug said. Following the single IVT injection of GB-102, patients will undergo monthly evaluation for eight months to assess safety, tolerability, and functional/pharmacodynamic parameters, including visual acuity and optical coherence tomography (OCT) measures of the retina, Graybug said.

Part two is a multicenter, double-masked, randomized, parallel-group, safety, and efficacy evaluation of repeated IVT injections of two dose levels of GB-102 compared with a standard IVT regimen of aflibercept, Graybug said.

Graybug said it also has a second-generation product under development, GB-103, that has potential to be a once-per-year IVT treatment for wet AMD.

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