---
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"
generated_at: "2026-05-16T14:13:27.278618+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Ocular Therapeutix to submit AXPAXLI NDA based on SOL-1 year 1 data after FDA flexibility signal

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-118940
- JSON: https://secwatch.observer/filing/0001104659-25-118940.json
- Plain text: https://secwatch.observer/filing/0001104659-25-118940.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.