Safety, Tolerability, and Efficacy Evaluation in 240 Participants Across 7 Hospitals
[Asia Economy Reporter Lee Gwan-joo] Yuyu Pharma announced on the 21st that it has completed the first patient enrollment for the Phase 2 clinical trial of its new drug for dry eye syndrome, 'YP-P10,' in the United States.
The Phase 2 clinical trial, approved by the U.S. Food and Drug Administration (FDA) in April, is being conducted at seven hospitals across the U.S. with 240 dry eye syndrome patients to evaluate the safety, tolerability, and efficacy of YP-P10.
YP-P10 is a new drug utilizing synthetic peptides. Preclinical trials confirmed that it has superior anti-inflammatory mechanisms and excellent corneal epithelial cell healing effects compared to existing drugs. The goal is to treat dry eye syndrome through anti-inflammatory and wound healing effects.
In preclinical studies, YP-P10 was more effective than lifitegrast, an existing dry eye treatment drug, in reducing the production of inflammatory cytokines and chemokines in human peripheral blood mononuclear cells (PBMCs). Additional studies on dry eye animal models showed reductions in various inflammation mediators related to dry eye and improvements in corneal damage. The company explained that these results indicate YP-P10 has anti-inflammatory effects similar to corticosteroids in treating dry eye syndrome.
Yoo Won-sang, CEO of Yuyu Pharma, said, "The Phase 2 clinical trial of YP-P10, Yuyu Pharma's first global clinical project, is progressing smoothly as planned," adding, "Yuyu Pharma will successfully complete the YP-P10 clinical trial to provide more effective and diverse treatment options to dry eye patients worldwide."
The prevalence of dry eye syndrome varies from 5% to 50% of the population and is much more common in women than men. A survey of 415 dry eye patients in the U.S. found that nearly half (48%) of respondents adhered to treatment, but only 13% experienced sustained symptom relief. The global dry eye syndrome market is expected to grow at an average annual rate of 6.14%, reaching $5.6 billion (approximately 7.3 trillion KRW) by 2026.
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