GenSight Biologics announced that the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) has granted the Company a six-month extension for submitting its responses to the Day 120 questions in the regulatory review of LUMEVOQ®, GenSight's gene therapy for the treatment of Leber Hereditary Optic Neuropathy (LHON). The Company requested the extension in order to implement process adjustments in the manufacturing of the validation (PPQ) batches required for marketing approval (GenSight Biologics Provides Update on LUMEVOQ® Manufacturing Timeline – GenSight Biologics (gensight-biologics.com). The Company is working with its manufacturing partner to implement targeted corrections around enhanced process control and more rigorous supervision inside the manufacturing suites.

In addition, smaller engineering lots will be used to confirm the robustness of the corrective actions. GenSight targets the restart of the PPQ campaign in third quarter of 2022. In the meantime, the Company has already finalized the responses to the D120 questions that were not related to the validation batches.

Responses to the Day 120 questions are now due in October 2022, after which regulatory review of LUMEVOQ®'s Marketing Authorisation Application will resume. The Company expects the opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) by third quarter of 2023, to be followed by commercial launch by the end of 2023.