Ajou Pharm and GL PharmTech(204840) jointly developed the dry eye disease treatment "Latica eye drops (ingredient name: recoplabon hydrate)," which has been approved as Korea's 44th homegrown new drug.
The Ministery of Food and Drug Safety said on the 8th that it approved "Latica eye drops 5% (ingredient name: recoplabon hydrate)."
Recoplabon is the first new dry eye disease treatment independently developed and approved by a domestic pharmaceutical company. The drug is used to promote mucus secretion on the ocular surface of adults with dry eye disease to improve corneoconjunctival epithelial disorders. The Ministery of Food and Drug Safety said it expects the approval to expand treatment options for patients with dry eye disease.
Recoplabon is a substance that GL PharmTech introduced under license from Dong-A ST(170900) in Nov. 2017. It then jointly carried out formulation improvements and clinical development with Ajou Pharm. GL PharmTech demonstrated efficacy over placebo in phase 3 clinical trials in Apr. last year, and in Nov. the same year applied for marketing authorization through its wholly owned subsidiary GL Pharma.
Latica eye drops were approved under the "New drug marketing authorization and review procedures" guideline established by the Ministery of Food and Drug Safety last year. The agency formed a 20-person product-dedicated team, including review specialists, and prioritized reviews of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
The Ministery of Food and Drug Safety said it proceeded with the authorization process through close communication, including holding tailored in-person meetings with the company before and after the marketing application.
An official at the Ministery of Food and Drug Safety said, "We plan to further enhance the predictability, transparency and speed of authorization and review so that medicines with confirmed safety and efficacy can be supplied to patients promptly."