APX3330 slows diabetic retinopathy progression in high-risk population
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INDIANAPOLIS — APX3330, an investigational oral treatment for diabetic retinopathy, reduced the development of proliferative diabetic retinopathy vs. placebo among high-risk patients, according to a poster presented at Academy 2024.
“This subset of high-risk patients for progression to proliferative diabetic retinopathy treated with APX3330 demonstrated a shift away from clinically meaningful disease progression toward clinically meaningful improvement vs. placebo,” Jessica Steen, OD, FAAO, associate professor at Nova Southeastern University, told Healio.
She added, “If there were to be a therapeutic option like this that were FDA-approved in the future, I think about how it may delay the need for injectable treatments, laser photocoagulation or vitrectomy for vision-threatening diabetic retinopathy or may increase the period of time between injections.”
To evaluate APX3300 (Opus Genetics) among individuals at increased risk for progression to proliferative diabetic retinopathy, Steen and colleagues conducted a subset analysis of 59 high-risk patients enrolled in the phase 2 ZETA-1 trial, which studied the treatment’s safety and efficacy in moderately severe to severe nonproliferative diabetic retinopathy.
According to results, a smaller proportion of patients treated with APX3330 demonstrated worsening in binocular diabetic retinopathy severity scale (DRSS) scores compared with placebo. By week 24, 3% of the treatment group had a three-step or more worsening compared with 20% of the placebo group, representing an 85% reduction in at least three-step progression, while 10% of the treatment group had at least a three-step improvement vs. 3% in the placebo group.
In the treatment group, only 7% developed proliferative diabetic retinopathy compared with 27% of the placebo group. Ocular adverse events were similar between groups and included pruritis and rash, which were typically mild and self-limited.
“The way that efficacy is measured needs to reflect the binocular impact of an orally administered agent,” Steen said. “This is very different from how we measure efficacy of an intravitreal agent that is delivered monocularly. The use of a binocular 17-step DRSS person-level scale has changed the way we think about measuring the effect of systemically administered therapeutics in diabetic retinopathy.”
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Steen J, et al. Efficacy of oral APX3330 for slowing progression of diabetic retinopathy using a binocular DRSS person-level scale. Presented at: Academy 2024; Nov. 6-9; Indianapolis.
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