Graybug Vision Initiates Clinical Trial in Macular Edema Secondary to Diabetic Macular Edema or Retinal Vein Occlusion
“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”
Graybug Vision, Inc., a clinical stage pharmaceutical company developing potentially transformative long-acting therapies for ocular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and primary open angle glaucoma (POAG), today announced the initiation of its Phase 2a study with GB-102 in patients with macular edema (ME) secondary to DME or 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, six-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 US. 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.
“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,” said Fred Guerard, President and Chief Executive Officer of Graybug Vision. “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 six-months or longer from a single intravitreal injection in wet AMD patients.
