---
schema_version: "secwatch.filing_event.v1"
accession: "0001372514-24-000099"
form_type: "8-K"
ticker: "KPRX"
cik: "0001372514"
company_name: "KIORA PHARMACEUTICALS INC"
filed_at: "2024-07-30T23:59:59+00:00"
generated_at: "2026-05-31T15:08:57.610286+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Kiora Pharma receives EU orphan designation for KIO-301 in inherited retinal dystrophies

## Summary
- EMA grants Orphan Medicinal Product Designation for KIO-301 in non-syndromic rod-dominant retinal dystrophies including retinitis pigmentosa.
- Provides at least 10 years of market exclusivity in Europe, reduced fees, centralized approval, and EMA scientific advice.
- KIO-301 already has US Orphan Drug Designation; Phase 2 ABACUS-2 trial expected to initiate later in 2024.
- KIO-301 is a small molecule photoswitch designed to restore light sensing in degenerated retinas, a non-gene therapy approach.
- Co-development and commercialization partner Théa Open Innovation covers ex-Asia territories.

## SEC filing metadata
- accession: 0001372514-24-000099
- form_type: 8-K
- ticker: KPRX
- cik: 0001372514
- company_name: KIORA PHARMACEUTICALS INC
- filed_at: 2024-07-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1372514/000137251424000099/0001372514-24-000099-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1372514/000137251424000099/kprx-20240730.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001372514-24-000099
- JSON: https://secwatch.observer/filing/0001372514-24-000099.json
- Plain text: https://secwatch.observer/filing/0001372514-24-000099.txt

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