MFDS approves 44th domestically developed novel drug, Laticca eye drops, for dry eye disease

The Ministry of Food and Drug Safety (MFDS) approved Laticca eye drops 5% (recoplavone hydrate), the 44th novel drug developed in South Korea, on the 8th.

MFDS said the drug is used to improve corneal and conjunctival epithelial disorders by promoting mucus secretion on the ocular surface in adults with dry eye disease. It added that the drug is expected to offer patients with dry eye disease a broader range of treatment options.

The approval was granted under the “New Drug Product Approval and Review Procedures” guideline established by MFDS last year. MFDS formed a dedicated 20-member product team, including review specialists, and prioritized review of the Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) requirements.

MFDS also said it completed the approval process quickly by maintaining close communication with the company, including holding tailored in-person meetings before and after the product approval application.

MFDS said it will continue to improve the predictability, transparency and speed of its approval reviews so that safe and effective medicines can be made available to patients promptly.