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Graybug begins phase 2b trial of GB-102 to treat wet AMD
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Graybug Vision initiated a phase 2b study of GB-102, a pan-VEGF receptor inhibitor and potential twice-per-year therapy, for the treatment of wet age-related macular degeneration.
The 12-month, three-arm randomized controlled ALTISSIMO study is evaluating GB-102 in 1 mg and 2 mg dose levels administered every 6 months vs. aflibercept 2 mg administered every 2 months. One hundred sixty patients with wet AMD will be enrolled at more than 100 clinical centers in the United States, according to a press release.
The therapy is designed to reduce the treatment burden and suboptimal visual outcomes experienced in real-world practice due to the number of injections and eye examinations needed each year.
Earlier this year, the phase 1/2a ADAGIO study met its primary endpoint of safety and tolerability. It provided evidence of a durable biological signal of 6 months or longer from a single intravitreal injection in wet AMD patients.
In addition, the therapy is being evaluated in patients with macular edema secondary to diabetic macular edema or retinal vein occlusion in an ongoing phase 2a study.