South Korea Approves Latika 5% as 44th Homegrown Drug
South Korea’s drug regulator approved Aju Pharm’s Latika Ophthalmic Solution 5% for improving corneal and conjunctival epithelial disorders in adults with dry eye disease.
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South Korea’s drug regulator approved Latika Ophthalmic Solution 5%, containing recoflavone hydrate, on September 8, 2026. The regulator designated the treatment as the country’s 44th domestically developed new drug.
Aju Pharm and GL Pharm Tech jointly developed the dry eye treatment. It is intended for adults with dry eye disease and works by promoting mucus secretion on the ocular surface to improve disorders of the corneal and conjunctival epithelium.
What the approval covers
The approval moves Latika Ophthalmic Solution 5%, also identified during development as AJU-S56, into the commercialization stage. Aju Pharm said this is its first drug to reach that stage after the company conducted late-stage clinical development and pursued product approval.
Aju Pharm said the product is the first domestically developed treatment for dry eye disease to obtain new-drug approval in South Korea. The regulator said the authorization could broaden treatment choices for people with dry eye disease.
Limits and patient context
The regulator reviewed the application under its new-drug approval and review procedures established in 2025. Its process included a 20-member product team, priority review of clinical-practice and manufacturing-quality matters, and tailored meetings surrounding the application.
The three reports do not give exact effectiveness rates or describe side effects, recovery considerations, dosing, or comparative outcomes. Because individual variation can affect treatment decisions, patients should consult a qualified physician about whether the approved indication fits their condition and what monitoring may be appropriate.
Questions for a consultation
A patient can ask whether the corneal or conjunctival epithelial problem associated with their dry eye matches the approved use of Latika Ophthalmic Solution 5%. A clinician can interpret that indication in light of the patient’s examination and treatment history.
Patients can also ask how a mucus-secretion-promoting treatment fits alongside their current eye medicines and what changes should prompt reassessment. These questions help connect the regulatory authorization to an individualized treatment discussion.
Frequently asked questions
What is Latika Ophthalmic Solution 5% used for?
It is approved for improving corneal and conjunctival epithelial disorders in adults with dry eye disease. Its stated mechanism is to promote mucus secretion on the ocular surface.
Who developed Latika eye drops?
Aju Pharm and GL Pharm Tech jointly developed the treatment. Aju Pharm obtained product approval from South Korea’s drug regulator on September 8, 2026.
Why is Latika called South Korea’s 44th homegrown drug?
South Korea’s drug regulator designated Latika Ophthalmic Solution 5% as the country’s 44th domestically developed new drug when approving it. The authorization covers its stated use in adults with dry eye disease.
Questions to take to your eye doctor
- Does my dry eye involve the corneal or conjunctival epithelial disorder covered by this approval?
- How would a treatment that promotes ocular-surface mucus secretion fit my current care?
- How should this medicine be considered alongside the eye drops I currently use?
- What monitoring would be appropriate if this medicine is prescribed?
- What personal factors should guide whether this approved indication applies to me?
MediIndex articles are for general information only and are not medical advice, diagnosis, or advertising. Outcomes vary by individual — consult a board-certified specialist for personal decisions.
