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FDA grants Toku Breakthrough Device status for its cardiovascular risk AI platform
November 2nd 2023The company’s AI CLAIR technology platform has received FDA breakthrough device status, and if cleared by the FDA will deliver real-time cardiovascular disease risk assessments through routine eye exams.
Clearside Biomedical completes recruitment in ODYSSEY Phase 2b clinical trial of CLS-AX in wet AMD
November 1st 2023The clinical trial will evaluate the safety and efficacy of CLS-AX (axitinib injectable suspension), a tyrosine kinase inhibitor. According to the company, topline data is expected during the third quarter of 2024.
Study: “Pseudo cell” formulation targets vitreoretinal disease
October 28th 2023Researchers have delved into the possibility of cell-based therapy in ophthalmology. By targeting vitreoretinal diseases, they are tackling a range of vision-threatening disorders which often result in severe irreversible vision loss.
FDA approves faricimab-svoa for the treatment of retinal vein occlusion
October 27th 2023According to Genentech, RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration and diabetic macular edema. The approval is based on two Phase III studies demonstrating early and sustained vision improvements that were non-inferior to aflibercept.
Visgenx issued patent for compositions of ELOVL2 gene therapy
October 26th 2023The issuance provides patent protection in the U.S. for therapeutics incorporating the optimized ELOVL2 transgene until 2041. The patent is being prosecuted in the European Union and other countries around the globe. The company said the patent adds value to its lead program in dry AMD.