Safety and Tolerability of Anti–microRNA-328 Ophthalmic Solution, SHJ002, in Pediatric Subjects: First-in-Human Clinical Study

• Published in: Clinical therapeutics Vol. 46; no. 10; pp. 768 - 772
• Main Authors: Chen, Jiunn-Liang, Lai, Wei-Yu, Lin, Reuy-Tay, Juo, Suh-Hang H., Liang, Chung-Ling
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2024; Elsevier Limited
• Subjects: Antisense therapy; Childrens health; Clinical outcomes; Clinical trials; Drug dosages; Eye; FDA approval; First-in-human; Genes; Health care; Health risks; Internal Medicine; Keratitis; MicroRNA-328; MicroRNAs; miRNA; Missing data; Myopia; Oligonucleotide; Pediatrics; Risk factors; United States > US; Oligonucleotide; MicroRNA-328; First-in-human; Myopia

•Excessive microRNA-328 in the eye is a risk factor for myopia.•An oligonucleotide was designed to neutralize microRNA-328 via eye drops instillation.•No adverse events were found in this trial.•The first-in-human trial demonstrated the novel eye drops was safe and tolerable in children. microRNA-32...