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Development

ONL is leveraging its breakthrough vision protection technology to develop novel treatments for a range of serious, vision-threatening retinal diseases and conditions.

The company’s lead therapeutic candidate, ONL1204 Ophthalmic solution, is a first-in-class small peptide that effectively inhibits the Fas receptor, thus blocking the activation of the Fas pathway and the related immune signaling which results in the death of key retinal cells and loss of vision.

ONL1204 Ophthalmic solution is currently in a Phase I clinical trial in Australia for the treatment of retinal detachment, a condition for which the compound has been granted orphan drug designation by the United States Food and Drug Administration (FDA). The company is completing additional preclinical activities for ONL1204 Ophthalmic solution in preparation for clinical development in key markets around the world for multiple indications.

About Retinal Detachment
Retinal detachment is an ocular condition that involves the retina being separated from the underlying layer of cells, including the retinal pigment epithelium (RPE). This separation often results in the death of key retinal cells, including photoreceptors, which can lead to vision impairment and/or loss.

The most prevalent form of retinal detachment is rhegmatogenous retinal detachment (RRD), which involves a tear in the retina. While standard of care surgical reattachment results in high rates of anatomic surgical success, in cases involving the macula (central vision), patients have significant loss of vision even with successful surgery. In part, this is due to the fact that photoreceptors begin to die once the detachment takes place and cell death continues up to the time of surgery (sometimes as long as a week).

In clinical use, ONL1204 Ophthalmic solution will be delivered to patients by intravitreal injection at the time of diagnosis to protect photoreceptors from death until standard of care surgery can be completed, enabling successful surgeries and improved patient outcomes.

Other Clinical Indications
While initial development efforts are focused on retinal detachment, preclinical in vivo data in several animal models of retinal disease, and a growing body of literature, support application in both wet and dry age related macular degeneration (AMD), glaucoma and non-infectious uveitis, among others. ONL is currently broadening its preclinical research of ONL1204 into these other retinal diseases with significant unmet medical needs.

Retinal detachment alone represents a >$500M global market opportunity, with several follow-on indications each representing multibillion-dollar markets.

ONL1204 Ophthalmic solution is currently in a Phase I clinical trial at two clinical sites, Save Sight Institute in Sydney and the Center for Eye Research Australia in Melbourne, for the treatment of retinal detachment. The company is completing additional preclinical activities for ONL1204 to enable clinical development in key markets around the world for multiple indications.