Kiora Pharmaceuticals Secures New Patent for KIO-104 Formulations, Extending Market Protection to 2043
核心洞察
Kiora Pharmaceuticals (搜索) received US Patent No. 12,472,263 covering additional and novel formulations of KIO-104, a DHODH (搜索) inhibitor for retinal inflammation (搜索) treatment.
The patent extends market exclusivity for KIO-104 to 2043 and expands potential therapeutic delivery options for the non-steroidal anti-inflammatory compound.
KIO-104 demonstrated clinical proof-of-concept in Phase 1 trials for non-infectious uveitis (搜索) and is currently being evaluated in the Phase 2 KLARITY study.
Kiora Pharmaceuticals (搜索) has received a new US patent (US Patent No. 12,472,263) from the US Patent and Trademark Office covering additional and novel formulations of the KIO-100 family of compounds. The patent specifically protects novel formulations of the active pharmaceutical ingredient in KIO-104, the company's lead ocular therapy candidate, and extends market exclusivity into 2043.
DHODH Inhibition Mechanism Offers Alternative to Steroids
KIO-104 contains a non-steroidal anti-inflammatory small molecule inhibitor of dihydroorotate dehydrogenase (搜索) (DHODH (搜索)), a mitochondrial enzyme that plays a key role in the synthesis of building blocks for both DNA and RNA. By inhibiting DHODH, KIO-104 offers an alternative treatment approach to steroids or systemic anti-inflammatory drugs for inflammatory-related vision loss.
"We believe DHODH (搜索) 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 & CEO of Kiora Pharmaceuticals (搜索). "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 (搜索)."
Phase 2 KLARITY Study Advancing
The company is currently conducting the Phase 2 KLARITY study, which is actively screening and dosing patients to evaluate higher doses of KIO-104 in multiple retinal inflammatory conditions. The multicenter trial will investigate KIO-104 in up to 28 patients at 2 dose levels across various forms of inflammatory retinal diseases, including posterior non-infectious uveitis (搜索) and diabetic macular edema (搜索).
The KLARITY study specifically focuses on patients with macular edema (搜索), a condition where inflammation causes fluid buildup behind part of the retina, potentially leading to adverse vision changes and permanent scarring. Results from the initial stage study will inform dose expansion decisions.
Strengthened Patent Portfolio
This latest patent adds to Kiora's intellectual property portfolio for KIO-104, following the company's announcement in July 2025 of securing US Patent No. 12,364,680 for the ocular therapy. The collection of patents is expected to strengthen protection of KIO-104 and provide extended market exclusivity.
The newly issued patent allows for additional delivery options, expanding the potential therapeutic utility of the API in KIO-104. As a potent, locally delivered small molecule, KIO-104 could provide a needed alternative to current treatment options for retinal inflammatory conditions.
Broader Pipeline Development
Beyond KIO-104, Kiora Pharmaceuticals (搜索) is developing KIO-301 for the treatment of retinitis pigmentosa (搜索), choroideremia (搜索), and Stargardt disease (搜索). The company recently granted Senju Pharmaceutical (搜索) an exclusive option to exercise rights to an exclusive development and commercialization agreement for KIO-301 for ophthalmic diseases in key Asian markets, including Japan and China.