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Corneal Endothelial
Cell Therapy

Two lab workers on either edge of the frame, turned looking at each other and smiling while holding lab equipment in front of a lab bay.

Our initial candidate aims to treat dystrophies that cause corneal blindness.

Pipeline

In Japan, early clinical research1 followed by dose-ranging and confirmatory clinical trials have successfully demonstrated the safety, efficacy, and tolerability of our first-generation cell therapy product, Vyznova. We have received regulatory approval from Japan’s PMDA.

In the United States and Canada, we are currently conducting a Phase 1/2 trial for our lead product candidate, AURN001. Enrollment and dosing for this trial have been completed and we announced topline data in the fourth quarter of 2024.

Product/
Product Candidate
Indication Preclinical Phase 1 Phase 2 Phase 3 Approved Next Anticipated Milestone
Vyznova Bullous keratopathy of the cornea Approved (Japan) Commercial Launch 2H 2024
AURN001 Corneal edema secondary to corneal endothelial dysfunction Phase 3 (U.S.) * Twelve-month topline results from U.S. Phase 3 trial in 2H 2025
Cryopreserved formulation** Corneal edema secondary to corneal endothelial dysfunction Phase 2 Twelve-month topline results from pilot clinical trial in Q1 2026
* Currently in Phase 3 development in the United States and Canada and clinical development planning stage in the EU
** Trial is taking place in El Salvador
Product/Product Candidate
Vyznova
Indication
Bullous keratopathy of the cornea
Phase
Approved (Japan)
Next Anticipated Milestone
Commercial Launch 2H 2024
Product/Product Candidate
AURN001
Indication
Corneal edema secondary to corneal endothelial dysfunction
Phase
Phase 3 (U.S.) *
Next Anticipated Milestone
Twelve-month topline results from U.S. Phase 3 trial in 2H 2025
Product/Product Candidate
Cryopreserved formulation**
Indication
Corneal edema secondary to corneal endothelial dysfunction
Phase
Phase 2
Next Anticipated Milestone
Twelve-month topline results from pilot clinical trial in Q1 2026

* Currently in Phase 3 development in the United States and Canada and clinical development planning stage in the EU

** Trial is taking place in El Salvador

Reference

  1. Kinoshita S, Koizumi N, Ueno M, et al. Injection of cultured cells with a ROCK inhibitor for bullous keratopathy. N Engl J Med. 2018;378(11):995-1003.

How it works