ONL Therapeutics to Present on ONL1204 in Podium Presentation at the 47th Annual Meeting of the Macula Society

 The presentation will review study population data from ONL’s Phase 2 study of ONL1204 Ophthalmic Solution in patients with Macula-Off Rhegmatogenous Retinal Detachment 

ANN ARBOR, Mich., January 23, 2024 – ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, announced today that David Zacks, M.D., Ph.D., chief scientific officer and co-founder of ONL Therapeutics, and the Edna H. Perkiss Research Professor of Ophthalmology and Visual Sciences at the Kellogg Eye Center of the University of Michigan, will present an update on the company’s Phase 2 study in patients with rhegmatogenous retinal detachment (RRD) at the upcoming 47th Annual Meeting of the Macula Society, being held February 7 – 10, 2024, at the La Quinta Resort & Club in Palm Springs, California. 

“We believe our Phase 2 randomized study to assess the safety and efficacy of intravitreal ONL1204 Ophthalmic Solution in patients with macula-off rhegmatogenous retinal detachment (RRD) could play an important role in treating this vision-threatening condition, and we look forward to sharing an update at the Macula Society meeting,” said David Esposito, chief executive officer of ONL Therapeutics. “With the study now fully enrolled we will focus our attention on gathering and analyzing the data with a goal to share topline results in the second quarter of 2024.” 

Details of the podium presentation are as follows: 

Title:
Fas Inhibition with ONL1204 for Macula-off Rhegmatogenous Retinal Detachment (RRD): Study Population Data on a Phase 2, Multicenter, Randomized, Sham-controlled, Single-Masked, Clinical Trial 

Presenter:
David N. Zacks, M.D., Ph.D. Chief Scientific Officer, ONL Therapeutics Edna H. Perkiss Research Professor of Ophthalmology and Visual Sciences, Kellogg Eye Center University of Michigan 

Date / Time:
Saturday, February 10, 2024, at 10:28 a.m. PT 

Session:
Surgery I (Retinal Detachment) 

About Rhegmatogenous Retinal Detachment 

Rhegmatogenous retinal detachment (RRD) is an acute and serious vision-threatening condition in which a tear in the retina allows liquefied vitreous to enter the subretinal space, thereby detaching the photoreceptor (PR) layer of the retina from the retinal pigment epithelium (RPE), the principal source of metabolic support for the PR layer. Once detached, PRs undergo a cascade of inflammation and cell death leading to vision loss after RRD. There are nearly 100,000 retinal detachment repairs annually in the US alone. 

About ONL1204 Ophthalmic Solution 

ONL1204 is a novel, first-in-class small molecule Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs across a range of retinal diseases and conditions. Death of these retinal cells, through both direct and inflammatory signaling pathways, is the root cause of vision loss and the leading cause of blindness. The company’s later-stage clinical development program for ONL1204 currently includes a Phase 2 study in the U.S. for the treatment of macula-off retinal detachment (NCT05730218), a condition for which the compound has been granted orphan drug designation by the United States Food and Drug Administration (FDA). The company is also conducting a Phase 1b clinical trial in patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) (NCT04744662) and a Phase 1b clinical trial in patients with progressing open-angle glaucoma (NCT05160805) at sites in Australia and New Zealand. Preclinical work is ongoing to enable clinical trials in other disease indications, including inherited retinal degeneration (IRD; also known as retinitis pigmentosa). 

About ONL Therapeutics 

ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to developing first-in-class therapeutics to protect and improve the vision of patients with retinal disease. By advancing a breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering a new approach to preserving vision. ONL is developing a platform of products for use in a wide range of blinding diseases, including retinal detachment, glaucoma, AMD and IRD. 

For more information about ONL Therapeutics, please visit www.onltherapeutics.com. 

Company Contact: Linda Kemnitz ONL Therapeutics, Inc. lkemnitz@onltherapeutics.com