Graybug Vision said yesterday that it launched the first clinical trial of its lead product, GB-102, in patients with wet age-related macular degeneration.
The two-part study is slated to evaluate patients being treated with available intravitreal anti-VEGF agents who are later switched over to just GB-102. The first part of the study will evaluate up to four dose levels of GB-102. Researchers plan to follow patients with monthly evaluation, assessing safety, tolerability, visual acuity and optical coherence tomography of the retina, for 8 months.
The second part of the study is designed to evaluate the safety and efficacy of repeated intravitreal injections of two dose levels of GB-102 compared to a standard intravitreal regimen of aflibercept (Eylea).
Graybug Vision’s lead product is a intravitreal injectable depot formulation of a tyrosine kinase inhibitor, sunitinib malate, that blocks multiple angiogenesis pathways, the company said. The novel formulation could potentially be administered just twice per year, Graybug Vision touted, according to preclinical studies.
“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,” CMO Dr. Charles Semba said in prepared remarks. “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.”
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