Opus Genetics and the FDA have reached an agreement on a special protocol assessment for a phase 3 clinical trial investigating oral APX3330 for the treatment of moderate to severe nonproliferative diabetic retinopathy.
According to a company press release, the FDA deemed the trial’s design, endpoints and planned analyses to be adequate to support a new drug application submission for the treatment if the outcomes are successful. The agreed primary endpoint will be a reduction in the binocular diabetic retinopathy severity scale of three steps or more with the treatment.
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