Research reaches Phase 2 b in clinical trial for wet age-related macular degeneration.
Posted: Wednesday, October 2, 2019 12:05 pm | Updated: 12:30 pm, Wed Oct 2, 2019.
Associated Press |
REDWOOD CITY, Calif.–(BUSINESS WIRE)–Oct 2, 2019–
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 2b study (ALTISSIMO) with GB-102 in patients with wet AMD.
AMD is the world’s leading cause of blindness among the elderly. While currently available anti-Vascular Endothelial Growth Factor agents (VEGF) have revolutionized care in patients with wet AMD, the need for frequent intravitreal (IVT) injections is burdensome for patients, their caregivers, and treating physicians.
GB-102, a pan-VEGF receptor inhibitor and potential twice-per-year therapy, is targeted to reduce the need for frequent IVT 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.
ALTISSIMO is a 12-month, 3-arm, randomized controlled study evaluating two dose levels of GB-102 (1 mg and 2 mg) administered every six months compared to aflibercept (2 mg) administered every two months in patients with wet AMD. The study will enroll 160 patients at more than 100 clinical centers in the United States. For more information, please refer to: https://clinicaltrials.gov/ct2/show/NCT03953079.
“Retinal specialists around the world are seeking longer lasting treatments to help better manage the growing number of patients presenting with wet AMD and other conditions,” said Arshad Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates, Reno, Nev., and clinical investigator for the ALTISSIMO study. “The ability to potentially offer a twice-per-year therapy using a simple intravitreal injection would be a significant advancement for ophthalmologists and their patients.”
Graybug Vision completed a Phase 1/2a study (ADAGIO) of GB-102 in the first quarter of 2019 which met its primary endpoint of safety and tolerability, and provided evidence of a durable biological signal of six months or longer from a single IVT injection in wet AMD patients. GB-102 is also being evaluated in an ongoing Phase 2a study in patients with macular edema secondary to DME or RVO.
GB-102 is Graybug Vision’s microparticle depot formulation of sunitinib malate for intravitreal (IVT) injection. The formulation consists of microparticles made from poly-lactic-co-glycolic acid (PLGA) combined with the company’s proprietary surface treatment designed to eliminate inflammation typically associated with ocular administration of PLGA. The surface treatment facilitates microparticle aggregation upon IVT injection to form a depot in the inferior vitreous. After IVT injection, the microparticles gradually release sunitinib malate and biodegrade into lactic and glycolic acid which are naturally cleared from the body…..
Source: OA online