Novel anti-VEGF for wet AMD meets safety, tolerability endpoint
WAIKOLOA, Hawaii — Sunitinib, a novel intravitreal anti-VEGF delivered via a biodegradable depot for extended treatment of neovascular age-related macular degeneration, met its primary endpoint of safety and tolerability, a speaker here said.
David Boyer, MD, delivered the 6-month phase 1/2a study results for GB-102 (Graybug Vision) at Retina 2019.
“There is a clear and durable pharmacodynamic effect of GB-102 based on the analysis of both best corrected vision and OCTs,” Boyer said. Thirty-two subjects with diagnosed neovascular AMD for less than 18 months were enrolled. All had received at least three prior anti-VEGF injections and had to be responsive to that treatment to be included in the trial. The subjects were evenly divided into four dosing groups: 0.25 mg, 0.5 mg, 1 mg and 2 mg.
Because all patients had responded to prior treatment, they had already achieved some improvement in visual acuity, which could account for why visual acuity remained about the same as at baseline throughout the study, even with rescue treatment, he said.
Similarly, for central subfield thickness measurements in all dosing groups, patients’ baseline values were improved with prior treatment and there was no significant decrease or change throughout the study.
“Once you gave this injection, these patients did very well. Over a 6-month period, very few of them required re-treatment,” Boyer said.
Dosing duration was achieved in approximately 90% of patients at 3 months and in approximately 70% of patients at 6 months without the need for rescue treatment. No dose-limiting toxicities or significant serious adverse events were reported.
There were, however, adverse events related to non-aggregation of the product once it was in the vitreous cavity. Nine patients (30%) reported events related to the particle dispersion, such as eye pain, photophobia, blurred vision and vitreous haze.
“The events were self-limited, and hopefully the manufacturing process will be optimized to eliminate the particle dispersion,” Boyer said. – by Patricia Nale, ELS
Kaiser PK, Boyer D. Most exciting retinal drugs: 2019. Presented at: Retina 2019; Jan. 20-25, 2019; Waikoloa, Hawaii.
Disclosure: Boyer reports he is a consultant for Graybug Vision.