ONL1204 ophthalmic solution is intended for the treatment of macula-off rhegmatogenous retinal detachment. Credit: Laurent Jollet on Unsplash.

ONL Therapeutics has dosed the first patient in a Phase II clinical trial of ONL1204 ophthalmic solution for the treatment of patients with macula-off rhegmatogenous retinal detachment (RRD).

Designed to evaluate the safety and efficacy of ONL1204, the randomised, controlled study will enrol 135 patients across 30 US sites.

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Divided into three arms, including two treatment groups and a sham group, patients will receive a single intravitreal (IVT) injection of ONL1204.

ONL Therapeutics co-founder and chief scientific officer David Zacks said: “We are excited to reach this important milestone in bringing ONL1204 to patients and clinicians in the United States for the first time.

“With its unique and differentiated mechanism of action targeting the Fas activation pathway, we look forward to advancing our clinical development for ONL1204 as a potential breakthrough neuroprotection therapy to address unmet medical needs across a number of disease areas including RRD.”

ONL1204, a small molecule Fas inhibitor, protects photoreceptors from cell death occurring due to various retinal diseases and conditions.

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The company is also carrying out two Phase Ib trials in patients with geographic atrophy (GA) associated with age-related macular degeneration and progressing open-angle glaucoma in Australia and New Zealand sites.

Preclinical work for enabling studies to treat other diseases including inherited retinal degeneration (IRD also known as retinitis pigmentosa), is ongoing.

In addition to RRD therapy, ONL is launching new products to treat various blinding diseases including glaucoma, AMD and IRD.