Q&A: First-ever allogeneic cell therapy to treat corneal endothelial disease approved
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Key takeaways:
- Vyznova received regulatory approval in Japan for the treatment of bullous keratopathy.
- Injectable endothelial cell therapy may alter the landscape of corneal endothelial disease treatment.
Vyznova cell therapy received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency for the treatment of bullous keratopathy, according to a press release from Aurion Biotech.
Aurion Biotech said this is the first regulatory approval in the world for an allogeneic cell therapy for corneal endothelial disease.
Healio/OSN spoke with Edward J. Holland, MD, the director of cornea services at Cincinnati Eye Institute and a professor of ophthalmology at the University of Cincinnati, about how the approval will transform cornea treatment and benefit ophthalmologists.
Healio/OSN: What is the prevalence of corneal endothelial disease globally, and what are the current treatments?
Holland: Epidemiologists estimate that approximately 4% of patients older than age 40 years have corneal endothelial disease. Yet today, globally, for every 70 diseased eyes, there is only one donor cornea available. There are more than 13 million people bilaterally blind worldwide from corneal disease. There is a profound need for more healthy corneal tissue. Today’s eye banking system with one cornea for one eye cannot begin to meet the global needs for corneal blindness.
There has been tremendous progress in the management of corneal endothelial disease in the last 20 years. The transition from penetrating keratoplasty to Descemet’s stripping endothelial keratoplasty to Descemet’s membrane endothelial keratoplasty has been an incredible improvement in surgical outcomes and patient experience. However, there are issues with present-day endothelial keratoplasty that can be improved.
All EK patients must spend 1 to 2 days flat on their back in order for the tissue to adhere. This position is a burden for all patients and is quite difficult to impossible to hold for others. In addition, EKs have a significant detachment rate requiring another application of an air bubble and another day in the supine position. DSEK and DMEK grafts, while successful, have a significant endothelial cell loss in the preparation and the surgical placement of the tissue.
Injectable endothelial cell therapy with Vyznova will improve on the surgical outcomes and the patient experience.
Healio/OSN: How will Vyznova change the treatment landscape for these conditions?
Holland: I believe injectable endothelial cell therapy will transform the treatment landscape by bringing it to more patients in need.
First, on the supply side, from a single donor, Aurion Biotech can produce enough cells to treat more than 100 eyes. That provides 100 times the supply for current EK procedures in which one donor cornea is used to treat each diseased eye.
Second, I believe that this will be a less onerous recovery process for patients. Instead of having to lie flat on their back for several days as needed for EK procedures, with endothelial cell therapy, the patient lies face down immediately after surgery. When discharged from postop, they can get up and resume activities of daily living.
Finally, Vyznova injectable endothelial cell therapy will improve on the surgical outcomes. Vyznova will not have issues of detachment and will result in a much higher endothelial cell count than present EK techniques.
Healio/OSN: When will Vyznova become available for patients internationally?
Holland: Aurion Biotech is working to bring its endothelial cell therapy through clinical development into other geographies. The company is in the process of preparing an investigational new drug application for the FDA in order to open clinical trials this year in the U.S. I am confident that other geographies will follow soon after.
Healio/OSN: How will this approval benefit ophthalmologists around the world?
Holland: As ophthalmologists, we frequently see patients with corneal endothelial diseases. The promise of corneal endothelial cell therapy is being able to treat more patients with a less onerous recovery, with better outcomes and perhaps even earlier in their disease.
We do not have anywhere near the number of corneas needed to treat all the world’s corneal blindness. With endothelial cell therapy, we will for the first time be able to make significant progress in reducing this number.
Healio/OSN: Is there anything you would like to add?
Holland: The PMDA approval from Japan is a landmark moment for ophthalmology. This is a first-in-the-world approval for a cell therapy to treat corneal disease. I am excited that in the years to come, we will see additional breakthroughs in cell therapy for treating eye diseases.
References:
- Aurion Biotech receives approval from Japan’s PMDA for new drug application. https://aurionbiotech.com/aurion-biotech-receives-approval-from-japans-pmda-for-new-drug-application/. Published March 23, 2023. Accessed March 27, 2023.
- Fuchs endothelial dystrophy. https://medlineplus.gov/genetics/condition/fuchs-endothelial-dystrophy/. Accessed March 27, 2023.
- Gain P, et al. JAMA Ophthalmol. 2016;doi:10.1001/jamaophthalmol.2015.4776.
For more information:
Edward J. Holland, MD, director of cornea services at Cincinnati Eye Institute and a professor of ophthalmology at the University of Cincinnati, can be reached at eholland@holprovision.com.
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