[Smart Summer Living] Dry Eye Syndrome Treatment, Phase 3 Clinical Trial Underway in Germany

[Asia Economy Reporter Choi Dae-yeol] HUONS' nano-composite eye drop (HU-007), currently under development, recently received approval for its Phase 3 clinical trial plan in Germany. Going forward, 35 institutions across Germany will conduct studies on patients with dry eye syndrome to evaluate the tear film protection effect and anti-inflammatory effect, as well as to assess the safety and efficacy of the combination therapy.

As fine dust spreads worldwide and smartphone use becomes widespread, ophthalmic diseases are increasing, leading to a sharp rise in demand for treatments. According to the pharmaceutical industry, the number of patients increases by about 20% annually, with the treatment market estimated at 300 billion KRW domestically and approximately 6 trillion KRW globally. Although the number of patients has increased, there are not many types of treatments. Dry eye syndrome treatments are mainly composed of single-agent drugs.

In particular, in Europe, only one cyclosporine formulation has approval as a prescription drug for treating dry eye syndrome. HUONS' HU-007 attracts attention because it is a rare combination drug. It combines cyclosporine, which has anti-inflammatory effects, with trehalose, an ingredient that protects the eyes.

The improved new drug HU-007 is designed to reduce the amount of cyclosporine used to less than half compared to existing single agents by making the particles very small, while providing the same anti-inflammatory effect and protecting the tear film to quickly relieve dry eye symptoms. The particles are broken down to the nano level, allowing immediate administration without shaking.

Although it has not yet received new drug approval, HU-007 has secured patents in a total of 11 countries including Korea, Europe, Russia, Indonesia, and Japan, recognizing these characteristics. Since the clinical trial is being conducted in Germany, where evaluations are stringent even within Europe, the company expects that if the trial proceeds successfully, HU-007 will be recognized as the first combination drug in the European dry eye treatment market.

Um Ki-an, CEO of HUONS, said, "Since the domestic Phase 3 clinical trial is progressing smoothly, we expect to successfully conduct the trial in Germany as well," adding, "After the clinical trial is completed, we will obtain product approval through the European Union (EU) centralized authorization procedure and target the European market."

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