ONL Therapeutics, a clinical-stage biopharmaceutical company focused on developing innovative treatments for retinal disease, has successfully enrolled more than 135 patients in a Phase 2 trial of its ONL1204 Ophthalmic Solution. This trial aims to evaluate the safety and efficacy of a single intravitreal injection of ONL1204 as an adjunct to standard-of-care surgery for macula-off rhegmatogenous retinal detachment (RRD).
The enrollment of over 135 patients in just four months marks a significant achievement for ONL Therapeutics. The randomized, controlled study involves three arms, including two treatment groups and a sham group, with participants recruited across 37 sites in the United States. With the completion of patient enrollment, ONL Therapeutics is now one step closer to providing a potential breakthrough therapy for patients suffering from RRD.
David Esposito, the CEO of ONL Therapeutics, expressed his enthusiasm about reaching this important milestone and emphasized the company’s commitment to advancing ONL1204 for retinal diseases such as RRD. Esposito also mentioned the anticipation surrounding the release of topline results from this study in the first half of next year.
The Chief Scientific Officer of ONL Therapeutics, David Zacks, M.D., Ph.D., expressed his gratitude towards the patients, families, and investigators involved in the Phase 2 trial. Their dedication and commitment have been instrumental in the swift recruitment process, highlighting the shared goal of bringing a promising neuroprotection therapy to patients suffering from RRD.
ONL1204 is a novel small molecule Fas inhibitor designed to protect crucial retinal cells, particularly photoreceptors, from cell death in various retinal diseases and conditions. The loss of these retinal cells, caused by both direct and inflammatory signaling pathways, is a major contributor to vision loss and the leading cause of blindness.
In addition to the Phase 2 trial for macula-off RRD, ONL Therapeutics is conducting Phase 1b clinical studies in geographic atrophy associated with age-related macular degeneration (AMD) and progressing open-angle glaucoma. These studies are being carried out at sites in Australia and New Zealand. The company is also engaged in preclinical work to enable future clinical trials targeting other disease indications, including inherited retinal degeneration.
ONL Therapeutics is dedicated to developing first-in-class therapeutics that protect and improve the vision of patients with retinal disease. Their breakthrough technology focuses on safeguarding key retinal cells from Fas-mediated cell death, offering a new approach to preserving vision. The company aims to provide a range of products to address various blinding diseases, including retinal detachment, glaucoma, AMD, and inherited retinal degeneration.
For more information about ONL Therapeutics and their innovative therapies in development, please visit their official website.
While the completion of patient enrollment in the Phase 2 trial of ONL1204 is a significant step forward, further research and analysis are needed to determine the safety and efficacy of this potential treatment. The topline results expected in the first half of 2024 will shed more light on the potential impact of ONL1204 in improving patients’ vision and quality of life.
