Kiora Pharmaceuticals Secures New U.S. Patent Strengthening KIO-104 Formulation And Delivery Options

Kiora Pharmaceuticals announced that the U.S. Patent and Trademark Office has granted a new patent (US-12,472,263) covering novel formulations within the KIO-100 family of compounds. This patent expands delivery possibilities for the active pharmaceutical ingredient used in KIO-104, potentially broadening its therapeutic applications. The protection specifically focuses on an innovative formulation of KIO-104’s API, a non-steroidal anti-inflammatory small molecule that inhibits dihydroorotate dehydrogenase (DHODH).

KIO-104 is currently being evaluated in an ongoing Phase 2 clinical study known as KLARITY, which is actively screening and dosing patients for retinal inflammation. The multicenter trial aims to enroll up to 28 individuals experiencing macular edema, a condition marked by inflammatory fluid buildup within the retina that can lead to vision impairment and long-term retinal damage. By offering a locally administered small-molecule alternative, KIO-104 may give patients a new option beyond steroids and systemic anti-inflammatory medications.

"We believe DHODH inhibitors have significant potential to slow, stop or reverse inflammatory-related vision loss, where steroids or other biologics are not providing appropriate benefit today," said Brian M. Strem, PhD, President & Chief Executive Officer of Kiora Pharmaceuticals. "KIO-104, our DHODH inhibitor formulated for local delivery into the retina, previously demonstrated clinical proof-of-concept in a Phase 1 trial in non-infectious uveitis. We're now enrolling in a Phase 2 study to evaluate higher doses of KIO-104 in multiple retinal inflammatory conditions including posterior non-infectious uveitis and diabetic macular edema."

Kiora continues to advance a pipeline of therapeutic candidates targeting major unmet needs in retinal disease. The company is developing KIO-301, a molecular photoswitch, for conditions such as retinitis pigmentosa, choroideremia, and Stargardt disease, with the goal of restoring visual function in patients with inherited or age-related degeneration. In parallel, KIO-104’s development is focused on treating retinal inflammation through next-generation, non-steroidal immunomodulation and targeted DHODH inhibition.