---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-106399"
form_type: "8-K"
ticker: "OCUL"
cik: "0001393434"
company_name: "OCULAR THERAPEUTIX, INC"
filed_at: "2023-10-03T23:59:59+00:00"
generated_at: "2026-06-10T05:23:48.186192+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Ocular Therapeutix initiates first pivotal trial of OTX-TKI for wet AMD

## Summary
- Activated first US clinical trial site; expects to enroll first subject by year-end 2023.
- Superiority trial of ~300 evaluable treatment-naïve wet AMD subjects randomized to aflibercept or OTX-TKI implant.
- Filed Special Protocol Assessment request with FDA for trial design; enrollment will wait for SPA feedback.
- OTX-TKI is an axitinib intravitreal implant, a potential long-acting therapy for wet AMD.

## SEC filing metadata
- accession: 0001104659-23-106399
- form_type: 8-K
- ticker: OCUL
- cik: 0001393434
- company_name: OCULAR THERAPEUTIX, INC
- filed_at: 2023-10-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1393434/000110465923106399/0001104659-23-106399-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1393434/000110465923106399/tm2327569d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-106399
- JSON: https://secwatch.observer/filing/0001104659-23-106399.json
- Plain text: https://secwatch.observer/filing/0001104659-23-106399.txt

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