GB-102 reduces annual injection burden in patients with wAMD

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In a Late Breaking Developments session at AAO 2021, Veeral Sheth MD, Director of Clinical Trials, University Retina and Macula Associates, Hinsdale, IL, discussed results from the Phase 2B ALTISSIMO trial, including a 6-month extended observation phase, evaluating GB-102 for the treatment of wet age-related macular degeneration (AMD).

GB-102 is injected intravitreally for controlled sustained drug delivery of sunitinib, TKI pan-VEGF inhibitor.

A total of 56 patients were included in the core study, with 21 patients receiving 1 mg of GB-102, 22 patients receiving 2 mg of GB-102, and a control group of 13 patients receiving 2 mg of aflibercept. All patients had been diagnosed with wAMD within 18 months of the start of the study; had ≥3 prior anti-VEGF injections with 1 occurring within the 21 days of the start of the study; demonstrated a response to prior anti-VEGF treatment; and BCVA of 25-28 letters.

The median duration in the GB-102 groups was 12 months in the extension study and 5 months in the core study.  However, more than 60% of rescues did not meet any criteria, Dr Sheth said.

“We saw good durability in the 1 mg group. We 81% of patients achieving 3 months or greater durability, 48% achieving 6 months or long, and 29 percent achieving 12 months or longer,” Dr Sheth said during the presentation.

Most adverse events were considered mild or moderate in severity with 5 serious adverse events in the 2 mg, leading to discontinuation at that dose.

A total of 50 out of 56 patients completed the 12-month treatment phase, with 28 of those patients continuing in the 6-month extension trial.

At 18 months, more than half of patients receiving 1 mg dose of GB-102 did not need supportive therapy.

Injection frequency was reduced by 63% in patients receiving 1 mg of GB-102 in the overall population and by 73% in patients who participated in the extension trial. Prior to enrollment patients received on average 10.1 injections per year compared to 3.8 injections per year on the study.

“That difference is even starker when you look at the patients who were in the Extension. There were 10.6 injections per year prior to enrollment and 2.8 injections per year on the study,” said Dr Sheth. “That’s a 73% reduction in treatment burden in these patients.”

Sheth V, et al.  Intravitreal Sunitinib Malate Depot (GB-102): Durability and Safety in Wet Age-Related Macular Degeneration (ALTISSIMO, Phase 2B).