MUTTENZ, Switzerland, Sept. 17, 2025 (GLOBE NEWSWIRE) — Opterion Health AG, a clinical-stage biopharmaceutical company developing OPT101 as an innovative treatment for patients on peritoneal dialysis (PD), today announced the submission of its Clinical Trial Application (CTA) to the European Medicines Agency (EMA). OPT101 is a novel non-glucose-based osmotic agent bringing much-needed new therapy options to patients with renal failure. The development of OPT101 represents the first innovation of its kind in over 30 years in the field of PD.
The CTA submission marks a significant milestone for Opterion in its mission to transform dialysis care and improve the quality of life for patients and their families. The company expects to initiate its first-in-human Phase 1 study, following regulatory approval.
“We are proud to have reached this important step in our development journey,” said Peter Reinemer, Chief Executive Officer of Opterion. “OPT101 has the potential to address long-standing limitations in peritoneal dialysis by eliminating glucose-based osmotic agents, which are associated with metabolic distress and PD complications. We are grateful to our team and partners for their dedication in bringing this innovation closer to patients.”
The Phase 1 SPARC trial will evaluate the safety, tolerability, and pharmacokinetics of OPT101 in patient volunteers. The data will inform future studies in patients with advanced CKD (chronic kidney disease) requiring peritoneal dialysis, a population with limited and often burdensome treatment options.
“The submission of our first-in-human clinical trial application for OPT101 represents a pivotal step forward in our mission to deliver innovative therapies for patients with advanced chronic kidney disease (CKD),” said Maxim Voropaiev, Chief Medical Officer of Opterion. “This Phase I clinical trial reflects our commitment to addressing significant unmet medical need in a growing patient population and we believe OPT101 has the potential to create meaningful clinical and economic value.”
David Ebsworth, Chairman of the Board of Opterion added: “For decades, dialysis patients have faced significant compromises in quality of life and long-term outcomes. OPT101 represents a bold step toward changing that paradigm. We believe that this submission for the SPARC trial is not only a regulatory milestone, but a signal of our commitment to advancing renal care for the PD community globally.”
The CTA submission follows recent strategic developments at Opterion, including the appointment of Rice Powell and Mark Hahn to the Board of Directors, and the expansion of business development activities in Europe, the U.S., and Asia.
About Opterion Health AG
Opterion Health AG is a Swiss-based biopharmaceutical company focused on transforming renal care through the development of novel therapies for peritoneal dialysis patients. Its lead candidate, OPT101, is designed to improve the quality of life of patients undergoing peritoneal dialysis and changing the odds of PD outcomes for those who rely on life-saving treatments.
Contact: info@opterion.com