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Dr. Sheth discusses the data from the late-breaking Phase 2B ALTISSIMO study.
In an interview with HCPLive, Veeral Sheth, MD, Director of Clinical Trials, University Retina, discussed the late breaking findings of the phase 2b ALTISSIMO trial data from the American Academy of Ophthalmology 2021 Meeting.
The data from the trial found the mean durability in 1 milligram GB-102 group was 12 months, in patients with wet age-related macular degeneration (wet AMD). Sheth noted the results of this data showed really good durability of the agent.
“We saw 55% of the patients in the one milligram group did not need rescue therapy in that last six months part of the observation, so they went 12 full months without needing any rescue therapy,” he said.
He continued with mentioning the 4 adverse events of iritis in the 1 milligram group, which were treated successfully with topical steroids. Sheth noted that anything that can be done to extend the life of a drug is valuable, balanced out with both efficacy and safety.
“Obviously, the nice thing about GB-102 Is it can be delivered via intravitreal injection,” he said. “So, it's easy to do in the clinic and monitor those patients as well.”
Sheth mentioned the recent FDA approval of port delivery systems, which can help to extend the life of a drug in a patient’s eye, leading to fewer injections and improved quality of life. He concluded with his excitement on the future of ophthalmology, noting it is an “exciting time to be in ophthalmology.”
“It's really exciting times that we have different mechanisms of actions that we're exploring different ways of extending dosing intervals,” Sheth said.
“Intravitreal Sunitinib Malate Depot (GB-102): Durability and Safety in Wet Age-Related Macular Degeneration (ALTISSIMO, Phase 2B),” was presented at AAO 2021.