Graybug Vision announced that it has begun dosing patients with wet AMD in its first clinical trial of GB-102, its lead product. GB-102 is a novel intravitreal (IVT) injectable depot formulation of sunitinib malate, a tyrosine kinase inhibitor that blocks multiple angiogenesis pathways (e.g., VEGFR-1,2,3) with the potential for twice per year treatment of wet AMD. In a preclinical in vivo study, sustained inhibitory drug levels in the retinal tissue were demonstrated through 6 months following a single IVT injection of GB-102. The multicenter clinical trial, which is being conducted in the US, is designed to evaluate the safety, tolerability and efficacy of GB-102, in patients with wet AMD.
"Wet AMD is a leading cause of irreversible vision loss in older adults and current treatments are extremely burdensome due to the need for frequent visits to the retinal specialist for IVT injections," Charles Semba, MD, Chief Medical Officer of Graybug Vision, said in a company news release. "We believe GB-102 has the potential for twice-yearly treatment and may provide the opportunity to dramatically change the standard-of-care by reducing the frequency of injections for patients and the treating physician."
This 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. Part 1 is a multicenter, open-label, single IVT injection study of up to four dose levels of GB-102 administered in ascending dosing cohorts. Following the single IVT injection of GB-102, patients will undergo monthly evaluation for 8 months to assess safety, tolerability, and functional/pharmacodynamic parameters including visual acuity and optical coherence tomography (OCT) of the retina. Part 2 is a multicenter, double-masked, randomized (1:1:1), parallel-group, safety, and efficacy evaluation of repeated IVT injections of two dose levels of GB-102 compared to a standard IVT regimen of aflibercept (Eylea).
Clinical centers are currently recruiting patients. For more information please go to https://clinicaltrials.gov/ct2/show/NCT03249740?term=graybug&recrs=a&cond=amd&rank=1.