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Regulator OKs Yuyu’s P2 clinical trial into dry eye treatment

Lee Han-soo  Published 2019.03.13  12:43  Updated 2019.03.14 16:43

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Yuyu Pharmaceutical said Wednesday that the Ministry of Food and Drug Safety has approved its phase 2 clinical trial into YY-101, a dry eye treatment.

Dry eye syndrome is a disease in which tears are lacking, or tears evaporate too quickly, which makes the eyes stiff. As the symptom directly affects the quality of life of individual patients, there is a need to develop a therapeutic agent for the syndrome that minimizes adverse effects.

The study will be a single institution, randomized, double-blind, placebo-controlled and incremental dose trial that will evaluate the tolerability, safety and efficacy of YY-101 in 30 patients.

The company conducted pre-clinical trials at Busan Paik Hospital, which is the center for eye disease technology to business while finishing phase 1 clinical trials at the Seoul National University Bundang Hospital, led by Professor Jung Yong-yong of the department of clinical pharmacology.

“The collagen type peptide, which is a major component of YY-101, was isolated from cartilage cell-derived extracellular matrix, while the company has already confirmed its safety,” said Baik Tae-gon, head of Yuyu’s research center. “There were no significant findings such as side effects of YY-101 in the clinical phase 1 in terms of safety and local tolerability.”

The company plans to accelerate the development of the drug with the approval of phase 2 clinical trial, Baik added.

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