[Edaily Reporter Minji Son ] A domestically developed treatment with a new mechanism of action is set to enter the Korean dry eye market, which has long been dominated by artificial tears. This follows the approval of a dry eye treatment jointly developed by GL Pharm Tech Corp.(204840)and Aju Pharmaceutical as the 44th domestically developed new drug. This achievement comes approximately nine years after the candidate compound was acquired from Donga ST in 2017.

On the 8th, the Ministry of Food and Drug Safety approved “Latica Eye Drops 5%” (recoplavone hydrate) as a treatment for improving corneal and conjunctival epithelial disorders in adult patients with dry eye syndrome. Latica is an eye drop that stabilizes the tear film by promoting mucus secretion on the ocular surface and aids in the recovery of damaged corneal and conjunctival epithelium.

GL Pharm Tech Corp. led the development process. After securing the rights to use recoplavone from Donga ST in November 2017, GL Pharm Tech Corp. conducted research to improve the formulation in order to increase the rate of drug absorption into the eye. Subsequently, the company partnered with Aju Pharmaceuticals to establish the joint venture Ocura BioScience in 2021 and jointly conducted Phase 2 and 3 clinical trials.

The Phase 3 clinical trial was conducted at 29 medical institutions in South Korea, involving 412 patients with dry eye syndrome. At week 12, the Latica treatment group showed statistically significant improvement in corneal staining test scores compared to the placebo group. Key secondary endpoints, including conjunctival staining test scores, the Ocular Surface Disease Index (OSDI), and ocular discomfort scores, also improved.

The remaining hurdles are setting the insurance reimbursement price and formulating a launch strategy. Given that the domestic dry eye disease treatment market is estimated to be around 500 billion won, Latica eye drops’ success will likely hinge on whether it can establish a foothold in the initial prescription market.

Meanwhile, this approval also marks the first application of the “Procedures for New Drug Product Approval and Review” guidelines established by the Ministry of Food and Drug Safety (MFDS) last year. The MFDS formed a dedicated 20-member product review team, including review specialists, and prioritized reviews of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) compliance. The agency also shortened the supplementary review process by holding in-person meetings with the developer both before and after the product approval application was submitted.