AGC Biologics and Oculis Enter Manufacturing Deal

AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), has entered a partnership with Oculis to manufacture OCS-02, a Phase II investigational drug targeting both Dry Eye Disease and Anterior Uveitis, at its Heidelberg facility.

“We are very pleased that Oculis has chosen us to manufacture this treatment,” said Mark Womack, chief business officer, AGC Biologics. “Our Heidelberg site has the experience and expertise to deliver this program from early phase to market.”

OCS-02 is a tumor necrosis factor-alpha (TNF alpha) inhibitor. TNF alpha is a proven biological target in ocular inflammation with possible dual actions: anti-inflammation and anti-necrosis. The OCS-02 compound is based on a proprietary single-chain antibody fragment technology specifically designed for topical delivery. The efficacy and safety of OCS-02 were evaluated in three clinical trials including two controlled studies under IND. The studies demonstrated a promising profile for treating ocular inflammatory conditions of the anterior segment of the eye including Dry Eye Disease and Non-Infectious Anterior Uveitis.

Dieter Kramer, general manager, AGC Biologics, said, “The Heidelberg team is excited to advance the process and analytics for this molecule to the next phase and is looking forward to a close collaboration with the Oculis team.”

AGC Biologics’ Heidelberg facility has over 20 years of experience delivering a very wide range of microbial programs. In addition, the site is AGC’s Center of Excellence for Plasmid DNA (pDNA) production, as part of their end-to-end Cell and Gene Therapy offering.