The FDA has granted clearance for a Phase III clinical trial of Gameto’s Fertilo, an iPSC-based therapy designed to mature reproductive eggs outside the body using engineered ovarian support cells. The therapy aims to reduce hormone injections by 80% and shorten treatment cycles, offering a less invasive approach to fertility treatment. Conducted across 15 U.S. sites, the trial will assess embryo development, pregnancy rates, and safety outcomes, with participants undergoing up to two days of hormone injections and up to two embryo transfers.
In parallel, Ocugen has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies on classifying its OCU400 therapy for retinitis pigmentosa as an Advanced Therapy Medicinal Product (ATMP). This classification enables Ocugen to engage more closely with regulators as it prepares for a 2026 marketing authorization filing. The therapy is currently in Phase III trials with the goal of broad patient accessibility by 2027.
Additionally, the California Institute for Regenerative Medicine has awarded a $6 million grant to researchers at the Keck School of Medicine of USC to advance a novel gene therapy for glioblastoma. The project, developed in collaboration with the University of Florida’s Zolotukhin Lab, will focus on a targeted delivery system aimed at improving precision while minimizing harm to healthy tissue. The team plans to refine the therapy in preparation for clinical trials.
These developments demonstrate the expanding potential of cell and gene therapies, with ongoing efforts to refine treatments for reproductive health, inherited retinal diseases, and aggressive cancers.
