{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-006490","form_type":"8-K","ticker":"OCUL","cik":"0001393434","company_name":"OCULAR THERAPEUTIX, INC","filed_at":"2024-01-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.037578+00:00","generated_at":"2026-06-06T18:06:44.915337+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Ocular Therapeutix obtains FDA SPA modification for pivotal Phase 3 AXPAXLI wet AMD trial","bullets":["FDA agreed to SPA modification for SOL trial evaluating AXPAXLI (axitinib intravitreal implant) for wet AMD.","Modified protocol allows enrollment of treatment-naïve subjects with visual acuity of 20/80 or better at screening.","Eligible participants must gain ≥10 ETDRS letters or achieve 20/20 vision at Day 1 after two aflibercept injections.","Trial will evaluate a single 450 µg implant of a more soluble form of axitinib for improved drug release.","Optimized implant designed to synchronize axitinib depletion with hydrogel bioresorption."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-006490","json":"https://secwatch.observer/filing/0001104659-24-006490.json","markdown":"https://secwatch.observer/filing/0001104659-24-006490.md","text":"https://secwatch.observer/filing/0001104659-24-006490.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1393434/000110465924006490/0001104659-24-006490-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1393434/000110465924006490/tm244106d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T18:06:44.915337+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}