Consistent with prior Type C Meeting, the Pre-NDA Meeting confirms Ocular’s plan to submit AXPAXLI NDA based on SOL-1 Week 52 efficacy and safety, interim SOL-R safety, and confirmatory evidence

AXPAXLI NDA submission for wet AMD remains on track for 4Q 2026

NDA submission to include subjects that have received multiple AXPAXLI injections in support of the Company’s application for repeat dosing

Commercial readiness accelerates ahead of potential 2027 launch as AXPAXLI is well positioned to potentially be the first TKI approved for wet AMD

BEDFORD, Mass., Sept. 15, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, "Ocular"))), an integrated biopharmaceutical company committed to redefining the retina experience, today announced the successful completion of its Pre-New Drug Application (NDA) Meeting with the U.S. Food and Drug Administration (FDA) for its investigational product candidate AXPAXLI™ (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD). Based on the Pre-NDA Meeting, the Company’s expectations for the AXPAXLI NDA package remain consistent with prior FDA communications, including the May 2026 Type C Meeting. Ocular remains on track to submit the NDA in the fourth quarter of 2026.