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[HEALTH] · South Korea · 4 sources

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GL Pharmtech and Aju Pharmaceutical receive approval for new dry eye drug

GL Pharmtech and Aju Pharmaceutical have received approval from the Ministry of Food and Drug Safety for Latica Eye Drops 5% (active ingredient: Recoflavone hydrate), marking South Korea’s 44th domestically developed new drug. This treatment is the first domestically developed new drug specifically for dry eye syndrome.

Latica Eye Drops works by promoting mucus secretion on the ocular surface of adult patients to improve corneal epithelial damage. The development process began approximately nine years ago when GL Pharmtech acquired the technology for Recoflavone from Dong-A ST in 2017. Following Phase 2 and Phase 3 clinical trials conducted jointly with Aju Pharmaceutical, the drug demonstrated statistically significant improvements in corneal staining scores and ocular surface disease index (OSDI) compared to placebo groups.

For Aju Pharmaceutical, this represents the company’s first successful commercialization of a new drug through its open innovation strategy, combining external candidate substances with internal clinical development and regulatory expertise.

Entities

Aju Pharmaceutical · GL Pharmtech · Ministry of Food and Drug Safety