ONL Therapeutics has concluded the enrolment of patients in its ongoing Phase II clinical trial of ONL1204 ophthalmic solution to treat macula-off rhegmatogenous retinal detachment (RRD).
The controlled, randomised study is designed to assess the safety and efficacy of a single intravitreal (IVT) injection of ONL1204 as an adjunct to standard-of-care surgical repair in macula-off RRD subjects.
A total of 135 patients aged 18 years and above were enrolled from 37 US sites. They will be divided into three arms including two treatment groups and a sham group.
The mean area under the log contrast sensitivity function, as measured with the adaptive sensory technology manifold contrast vision metre, at week 24 is the primary outcome measure of the study.
ONL Therapeutics CEO David Esposito said: “We look forward to sharing topline results from this study in the first half of next year and to completing our Phase Ib clinical studies in the chronic indications of geographic atrophy associated with age-related macular degeneration and progressing open-angle glaucoma, both of which are being conducted at sites in Australia and New Zealand.”
ONL1204 is a small molecule Fas inhibitor that protects key retinal cells including photoreceptors from cell death.
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The compound also previously received orphan drug designation from the US Food and Drug Administration (FDA).
ONL Therapeutics co-founder and chief scientific officer David Zacks said: “The level of enthusiasm and partnership from our sites has been tremendous as we work toward our common goal of bringing a novel neuroprotection therapy to patients suffering from RRD.”