{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-100234","form_type":"8-K","ticker":"OCUL","cik":"0001393434","company_name":"OCULAR THERAPEUTIX, INC","filed_at":"2023-09-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.772600+00:00","generated_at":"2026-06-10T18:56:18.943294+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Ocular Therapeutix submits SPA request to FDA for OTX-TKI pivotal trial in wet AMD","bullets":["Submitted SPA request for first of two planned pivotal trials of OTX-TKI for wet AMD.","Trial designed as superiority comparing single OTX-TKI implant vs single aflibercept injection.","Approximately 300 treatment-naïve wet AMD subjects to be enrolled.","Trial to be prospective, multi-center, randomized, parallel-group, mostly at U.S. sites.","Company believes protocol aligns with prior FDA discussions and draft guidelines."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-100234","json":"https://secwatch.observer/filing/0001104659-23-100234.json","markdown":"https://secwatch.observer/filing/0001104659-23-100234.md","text":"https://secwatch.observer/filing/0001104659-23-100234.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1393434/000110465923100234/0001104659-23-100234-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1393434/000110465923100234/tm2326026d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T18:56:18.943294+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"}