MFDS Approves 'Latica Eye Drops,' the 44th Domestically Developed New Drug

[Financial News] The Ministry of Food and Drug Safety has approved a dry eye treatment as the 44th new drug developed in Korea.
The Ministry of Food and Drug Safety approved 'Latica Eye Drops 5% (Recoflavone Hydrate)' on the 8th, which improves corneal and conjunctival epithelial disorders by promoting mucus secretion on the surface of the eye in adult patients with dry eye syndrome.
Latica Eye Drops are a treatment that improves symptoms of dry eye syndrome by promoting mucus secretion on the surface of the eye. With this approval, a new treatment option is expected to be added for patients with dry eye syndrome.
The Ministry of Food and Drug Safety supported the rapid approval of this product in accordance with the 'New Drug Product Approval and Review Procedures' guidelines enacted last year. A dedicated product team of 20 members, including review specialists, was formed, and matters related to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) were reviewed as a priority.
In addition, customized face-to-face meetings were held with the company before and after the product approval application to closely coordinate matters necessary for the approval review process.
An official from the Ministry of Food and Drug Safety stated, "We will enhance the predictability, transparency, and speed of the approval review process so that safe and effective medicines can be promptly provided to patients."

[email protected] Jeong Sang-hee Reporter