Atsena Therapeutics has received orphan designation from the European Medicines Agency for its two clinical‑stage gene therapy candidates, ATSN‑101 for Leber congenital amaurosis 1 and ATSN‑201 for X‑linked retinoschisis. The company said the decision provides development incentives and market exclusivity in the EU as both programmes advance through global pivotal trials. Orphan designation in Europe is granted to therapies intended for rare, life‑threatening or chronically debilitating conditions and provides benefits such as reduced regulatory fees, protocol assistance and up to 10 years of market exclusivity. Atsena dosed the first patient in the pivotal phase 3 cohort of the LIGHTHOUSE trial for ATSN‑201 in June 2026 and enrolment is progressing ahead of expectations. A global pivotal phase 3 trial of ATSN‑101 is expected to begin later this year.