{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-118940","form_type":"8-K","ticker":"OCUL","cik":"0001393434","company_name":"OCULAR THERAPEUTIX, INC","filed_at":"2025-12-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.293420+00:00","generated_at":"2026-05-16T14:13:27.278618+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Ocular Therapeutix to submit AXPAXLI NDA based on SOL-1 year 1 data after FDA flexibility signal","bullets":["FDA signals may allow single pivotal trial for AXPAXLI in wet AMD, changing prior two-trial requirement.","Ocular Therapeutix now plans to submit NDA based on year 1 data from SOL-1 Phase 3 trial.","Top-line year 1 data from SOL-1 expected in Q1 2026.","Company will engage with FDA on regulatory pathway for AXPAXLI."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-118940","json":"https://secwatch.observer/filing/0001104659-25-118940.json","markdown":"https://secwatch.observer/filing/0001104659-25-118940.md","text":"https://secwatch.observer/filing/0001104659-25-118940.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1393434/000110465925118940/0001104659-25-118940-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1393434/000110465925118940/tm2532882d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:13:27.278618+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"}