Ajou Pharmaceutical Obtains Product Approval for Korea's 44th New Drug, "Latica Eye Drops 5%"

First Domestically Developed New Drug for Dry Eye Disease
Ajou Pharmaceutical Achieves First Successful Commercialization
Proven Capabilities in Joint Development and Open Innovation for Clinical Development and Approval
Advancing as an R&D-Focused Innovative New Drug Developer

Front view of Ajou Pharm building (Photo by Ajou Pharm)

Ajou Pharmaceutical (CEO Kim Taehoon) and GL PharmTech announced on September 8, 2026, that they have obtained product approval for "Latica Eye Drops 5% (Recoflavone Hydrate)," a treatment for dry eye disease jointly developed by the two companies, and it has been recorded as Korea's 44th new drug.

Ajou Pharmaceutical has, for the first time since its founding, driven and completed the entire process of new drug development, from clinical development to product approval. Becoming the 44th new drug in Korea and proving its clinical development capabilities with product approval mark a significant turning point for the company. This treatment is the first new dry eye drug developed domestically, presenting a new option for clinical practice.

In the future, Ajou Pharmaceutical plans to leverage this new drug development process to strengthen its own research infrastructure while expanding its open innovation model by actively sourcing external technologies and candidate substances. The company aims to continue discovering and commercializing new drug candidates through a combination of in-house research and external collaboration.

The main ingredient of Latica Eye Drops 5%, Recoflavone Hydrate (Recoflavone), is a derivative of eupatilin and is a new drug candidate with pharmacological properties related to reducing inflammation on the ocular surface and repairing damaged tissues. Ajou Pharmaceutical recognized these pharmacological features and the potential of Recoflavone Hydrate as a dry eye treatment, leading the company to pursue further development including phase 2 and phase 3 clinical trials, as well as handling the product approval process.

Dry eye disease is a chronic ocular surface condition that impacts patients' daily lives and quality of life by causing symptoms such as dryness, foreign body sensation, irritation, and visual discomfort. As the demand for treatment continues to rise due to population aging and increased use of digital devices, there is growing need for new treatment options that not only alleviate symptoms but also improve the function and environment of the ocular surface.

Recoflavone Hydrate, developed with these dry eye characteristics in mind, is distinguished by its multifaceted action on the eye surface. Nonclinical studies have shown that it promotes mucin production and modulates inflammatory responses, in addition to various effects associated with corneal epithelial recovery. This suggests potential for a new therapeutic approach that goes beyond simply supplementing tear deficiency, by actively restoring homeostasis on the ocular surface.

The arrival of Latica Eye Drops 5%, which supports the restoration of ocular surface homeostasis through multi-target pharmacological action, is being evaluated as a new alternative in the market.

Ajou Pharmaceutical directly led the clinical trials and managed the product approval work, accumulating in-house expertise and experience across clinical trial design and operation, data management, regulatory response, and all aspects of new drug clinical development.

This product approval is particularly significant as an example of bridging promising external candidate substances through joint development, late-stage clinical trials, and final approval. It demonstrates that Ajou Pharmaceutical's open innovation strategy has led to concrete new drug development success. By combining the expertise of external partners who possess strong technologies and candidate substances with Ajou Pharmaceutical's clinical development, approval, and commercialization capabilities, the company has proven its ability to maximize the clinical value of new drug candidates and guide them through to commercialization.

In particular, Latica Eye Drops 5% represents more than just the approval of a single product for Ajou Pharmaceutical; it marks the company’s expansion from its accumulated development and manufacturing capabilities into the areas of clinical development and commercialization. Ajou Pharmaceutical intends to actively apply its newly acquired experience and expertise to developing new pipelines, while accelerating preparations for the successful domestic launch and market establishment of Latica Eye Drops 5%.

A representative from Ajou Pharmaceutical commented, "Latica Eye Drops 5% will be an important milestone in the company's R&D history, as it is the first new drug that Ajou Pharmaceutical has successfully advanced from late-stage clinical development and approval to the commercialization stage since its founding. As the 44th new drug in Korea, we will do our utmost to ensure a successful launch and market entry, providing new treatment options for patients with dry eye disease."

The representative added, "In new drug development, strengthening our own R&D capabilities is important, but so is discovering excellent technologies and combining the expertise of companies with diverse specialties to increase the probability of success. Based on the clinical development, approval, and commercialization experience gained through this achievement, we will further strengthen our own research and development while expanding strategic open innovation partnerships with domestic and international universities, research institutes, biotech ventures, and pharmaceutical companies to continuously build a competitive new drug pipeline."

Ajou Pharmaceutical intends to take this opportunity, marked by the approval of Korea’s 44th new drug, to further strengthen open innovation as a core R&D strategy, and to continuously enhance its new drug development capabilities, from sourcing promising technologies to clinical development, approval, and commercialization.

This content was produced with the assistance of AI translation services.