On April 23, the U.S. FDA approved Regeneron's Otarmeni (rusaretogene fardavec-cwha) as the world's first gene therapy for hereditary hearing loss. The indication is for pediatric and adult patients with severe to profound sensorineural hearing loss confirmed to have biallelic mutations in the OTOF gene. This AAV1 vector-based gene therapy works by delivering a normal copy of the OTOF gene to inner ear cells through a single surgical administration, thereby restoring auditory signal transmission. In clinical trials, 80% of the 20 evaluable participants showed hearing improvement. The approval came just 61 days after the Biologics License Application (BLA) submission, marking one of the fastest BLA approvals in recent FDA history. This approval is not merely the "first hearing loss treatment"; it represents a turning point in two significant trends. First, it demonstrates the expansion of gene therapy for hereditary diseases beyond "a subset of rare diseases" to include "sensory organs," suggesting future possibilities for application in vision, olfaction, and neurological fields. Second, the approval of an AAV-based new drug through the FDA's Critical National Priority Voucher (CNPV) program with an expedited review of approximately 60 days signals to global gene therapy developers that "the FDA is paving the way." Regeneron has also announced that it will provide Otarmeni free of charge in the U.S., setting another benchmark in the gene therapy market, which has faced significant pricing controversies. This is undoubtedly one of the most impactful global healthcare headlines this week.