Korea approves Latica eye drops, its first homegrown dry eye treatment

South Korea has produced its 44th homegrown new drug and, for the first time, a domestically developed treatment for dry eye disease.

The Ministry of Food and Drug Safety said Wednesday that it had approved Latica Ophthalmic Solution 5% (ingredient name recoflavone hydrate) as the country's 44th locally developed new drug. The prescription medicine was jointly developed by GL Pharm Tech, a biotech venture specializing in improved new drugs, and Aju Pharm, a midsize pharmaceutical company.

According to market researcher UBIST, the domestic dry eye treatment market is worth about 500 billion won ($372 million). The market currently sees fierce competition among a range of drugs, including hyaluronic acid-based artificial tears as well as cyclosporine, diquafosol and rebamipide formulations.

Latica works by promoting mucus secretion on the ocular surface of adult dry eye patients, helping repair damaged corneal and conjunctival epithelium. While the dry eye treatment market has long been dominated by artificial tear products such as hyaluronic acid solutions and anti-inflammatory immunosuppressant eye drops, the arrival of a domestically synthesized new drug that directly induces mucus secretion to treat corneal damage gives patients a new treatment option.

Dry eye treatments face an unusually difficult path to approval because symptoms vary widely among patients and stem from complex causes, including tear film breakdown and inflammation. Drugmakers must prove improvement in both objective signs and subjective symptoms simultaneously. In practice, numerous biotech companies at home and abroad have failed to demonstrate efficacy over placebo at the Phase 3 trial stage. Several domestic firms have either halted development after failing to prove efficacy or revised their evaluation metrics and pursued new trials.

Amid this string of setbacks, close cooperation between a midsize Korean pharmaceutical company and a biotech venture bore fruit. Development of the source material behind Latica began in earnest in 2017, when GL Pharm Tech obtained rights to use recoflavone from Dong-a ST. GL Pharm Tech then led research to improve the drug's absorption rate and therapeutic effect. It later teamed up with Aju Pharm to successfully complete a large-scale Phase 3 trial and clear the final hurdle to commercialization. The drug is considered a model case of open innovation. It combines a major pharmaceutical company's source material, a biotech venture's proprietary formulation technology, and a midsize drugmaker's clinical execution capabilities.

This is also the first approval granted under an expedited review process based on the Ministry of Food and Drug Safety's "New Drug Item Approval and Review Procedures" guideline. The ministry enacted the guideline in 2025. It formed a 20-member "Latica task force," including review specialists, to prioritize examination of Good Clinical Practice and Good Manufacturing Practice standards. It also held ongoing customized in-person meetings with the companies before and after the approval application, significantly shortening the review period.

"We plan to continue enhancing the predictability and transparency of drug approval and review so that safe and effective new drugs can be swiftly supplied to patients," the Ministry of Food and Drug Safety said.