South Korea’s Ministry of Food and Drug Safety has approved recoflavone (Latica/Recodu) for moderate to severe dry eye disease. Developed jointly by GL PharmaTech and Aju Pharmaceutical, recoflavone is the first domestically developed dry eye disease treatment approved in South Korea and the third prescription treatment authorized for the indication. The approval is expected to intensify competition in the country’s dry eye market, according to GlobalData, a leading intelligence and productivity platform.
Dry eye disease is chronic and clinically heterogeneous, with symptoms that can recur and affect quality of life. Treatment persistence can also be limited by local tolerability issues and the burden of long-term therapy. These unmet needs continue to support demand for therapies that offer an acceptable safety profile and sustained symptom control.
The approval of recoflavone was supported by Phase III clinical data that demonstrated recoflavone’s safety and efficacy relative to placebo. Recoflavone offers a competitive dosing schedule among mucin-stimulating agents, requiring four times daily administration. Recoflavone follows cyclosporine (Santen Pharmaceutical and Allergan/AbbVie) and diquafosol tetrasodium (Santen Pharmaceutical) as approved dry eye disease treatments in South Korea. The companies plan to commercialize the product in the second half of 2027.
Abhishake Peyyeti, Pharma Analyst at GlobalData, comments: “Recoflavone’s commercial success will depend on how its clinical profile, pricing, and market access compare with established therapies, including cyclosporine and diquafosol. The launch may also encourage further domestic investment and partnering in ophthalmology, particularly as local companies seek to expand beyond the South Korean market.”
According to the GlobalData Pharma Intelligence Center, five dry eye disease assets are in clinical development in South Korea: two in Phase III, two in Phase II, and one in Phase I.
Peyyeti concludes: “South Korea’s dry eye disease pipeline remains relatively small but includes late-stage programs that could intensify competition. For GL PharmaTech and Aju Pharmaceutical, commercializing recoflavone provides a platform to validate their ophthalmology portfolio domestically while pursuing global out-licensing agreements. Competing internationally will require clear clinical differentiation, regulatory progress outside South Korea, and strong co-development partners to challenge established multinational players such as Bausch + Lomb, Santen, and Alcon.”
