Keratoconus of eye, 4th degree. Credit: Garna Zarina via Shutterstock

Cellusion plans to begin a Phase I/II trial for its bullous keratopathy candidate CSL-001 in 2024, says CEO Shin Hatou. After this, the company will begin a US Phase I/II study for the therapy in 2025, notes Hatou. The Tokyo, Japan-headquartered company aims to submit an investigational new drug (IND) application to the US Food and Drug Administration (FDA) in 2025.

Hatou says the company may look to increase funding in the next few years either through further financing rounds or a possible initial public offering. Cellusion would be interested in continuing to work with its current investors and remains open to new investment opportunities to achieve this, he adds.

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Takuya Kaneko, Cellusion’s chief financial officer (CFO), says that the company aims to launch sales of CSL-001 in Japan by 2027. He says the company is looking for an alliance partner to support the product’s development in the US and in the rest of the world.

Bullous keratopathy is an eye disease in which the cornea become permanently swollen due to damage to its inner-most layer. Hatou reported that the disease leads to 130,000 surgeries per year, resulting in waiting lists being 13,000 patients long.

CSL-001 is an induced pluripotent stem cell therapy that is derived from corneal endothelium cells. The therapy replaces the pathogenic corneal cells to allow healthy corneal cells to grow, leading to regenerative effects. In first in human trials, the therapy succeeded in reducing the corneal swelling by 250µm in patients.

In a June 2023 Series C financing round, the company raised 2.83 Billion Yen ($21 Million) to further the clinical development of CSL-001. The financing round was led by the company’s investors including IC Venture Growth Investments, the University of Tokyo Edge Capital Partners and JIC Venture Growth Investments. Cellusion has raised 4.5 billion yen ($33 million) for the development of its pipeline to date.