Graybug Vision announced the initiation of its phase 2a study with GB-102 in patients with macular edema (ME) secondary to diabetic macular edema (DME) or retinal vein occlusion (RVO).
GB-102, a pan-Vascular Endothelial Growth Factor (VEGF) inhibitor and potential twice-per-year therapy is targeted to reduce the need for frequent intravitreal injections in retinal diseases, including wet AMD, DME, and RVO. GB-102 seeks to reduce the significant treatment burden and sub-optimal visual outcomes experienced in real-world practice due to the challenge patients face in visiting the retinal specialist several times a year for needed injections and eye examinations.
The GB-102 phase 2a open label, 6-month study is intended to establish the safety of GB-102 and provide preliminary evidence of its durability in ME patients secondary to DME and RVO. It will enroll 20 ME patients at six centers in the United States. They will be treated with a single intravitreal injection of 1 mg or 2 mg of GB-102, Graybug Vision’s microparticle depot formulation of sunitinib malate.
Clinical centers are currently recruiting patients for the study. For more information, please refer to: https://clinicaltrials.gov/ct2/show/NCT04085341
“DME and RVO frequently cause irreversible vision loss in older adults and currently available treatments are extremely burdensome for patients, their caregivers, and treating physicians due to the need for frequent intravitreal injections,” Fred Guerard, President and Chief Executive Officer of Graybug Vision, said in a company news release. “With its potential of a twice-per-year therapy, GB-102 could substantially transform patient outcomes and improve the current clinical practice.”
GB-102 completed a phase 1/2a study (ADAGIO study) in Q1 2019 in which it met its primary endpoint of safety and tolerability and provided evidence of a durable biological signal of 6 months or longer from a single intravitreal injection in wet AMD patients.