Graybug Vision has initiated the ALTISSIMO clinical trial, a phase 2b study, which will evaluate its pan-VEGF receptor inhibitor GB-102 in patients with wet age-related macular degeneration (wet AMD).
Based in California, Graybug Vision is a clinical-stage pharma company engaged in developing drugs for ocular diseases like wet AMD, diabetic macular edema (DME), primary open angle glaucoma (POAG), and retinal vein occlusion (RVO).
GB-102 has been designed as a twice-per-year therapy targeted to cut down the need for regular IVT injections in retinal diseases, including wet AMD, RVO and DME.
The pan-VEGF receptor inhibitor is aimed at reducing the significant treatment burden and sub-optimal visual outcomes encountered in real-world practice owing to the challenge patients experience in visiting the retinal specialist several times a year for the necessary injections and eye examinations.
Commenting on the ALTISSIMO clinical trial, Arshad Khanani – Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, and clinical investigator for the ALTISSIMO study, said: “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.
“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.”
The ALTISSIMO clinical trial is a 12-month, three-arm, randomized controlled study that will assess a couple of dose levels of GB-102, at 1mg and 2mg. The doses will be given every six months and will be studied in comparison to aflibercept at 2mg given every two months in patients having wet AMD.
Graybug Vision said that the ALTISSIMO clinical trial will feature 160 patients at 100 plus clinical centers across the US.
The US pharma company, in the first quarter of 2019, wrapped up the ADAGIO clinical trial, which is a phase 1/2a study that evaluated GB-102. The ADAGIO clinical trial met its primary endpoint of safety and tolerability, while giving 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 studied in an ongoing phase 2a study in patients with macular edema secondary to DME or RVO.