---
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"
generated_at: "2026-06-10T18:56:18.943294+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Ocular Therapeutix submits SPA request to FDA for OTX-TKI pivotal trial in wet AMD

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-100234
- JSON: https://secwatch.observer/filing/0001104659-23-100234.json
- Plain text: https://secwatch.observer/filing/0001104659-23-100234.txt

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