---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-006490"
form_type: "8-K"
ticker: "OCUL"
cik: "0001393434"
company_name: "OCULAR THERAPEUTIX, INC"
filed_at: "2024-01-25T23:59:59+00:00"
generated_at: "2026-06-06T18:06:44.915337+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Ocular Therapeutix obtains FDA SPA modification for pivotal Phase 3 AXPAXLI wet AMD trial

## Summary
- FDA agreed to SPA modification for SOL trial evaluating AXPAXLI (axitinib intravitreal implant) for wet AMD.
- Modified protocol allows enrollment of treatment-naïve subjects with visual acuity of 20/80 or better at screening.
- Eligible participants must gain ≥10 ETDRS letters or achieve 20/20 vision at Day 1 after two aflibercept injections.
- Trial will evaluate a single 450 µg implant of a more soluble form of axitinib for improved drug release.
- Optimized implant designed to synchronize axitinib depletion with hydrogel bioresorption.

## SEC filing metadata
- accession: 0001104659-24-006490
- form_type: 8-K
- ticker: OCUL
- cik: 0001393434
- company_name: OCULAR THERAPEUTIX, INC
- filed_at: 2024-01-25T23:59:59+00:00
- event_type: regulatory
- 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/1393434/000110465924006490/0001104659-24-006490-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1393434/000110465924006490/tm244106d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-006490
- JSON: https://secwatch.observer/filing/0001104659-24-006490.json
- Plain text: https://secwatch.observer/filing/0001104659-24-006490.txt

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