Allotex today announced five-year clinical observations presented in an ESCRS Free Paper by Cafer Tanrıverdi, MD, and collaborators from Medipol University and other clinical institutions in Istanbul. The study evaluated sterile human corneal tissue profiles prepared according to physician-defined geometries and placed in eyes described by the investigators as hyperopic.
The ESCRS presentation followed how precision-defined sterile human corneal tissue profiles behaved in the cornea over time. The observations included corneal transparency, tissue integration, tissue thickness, corneal shape, and densitometry findings.
The tissue profiles evaluated in the study were supplied by Allotex and processed into physician-defined geometry. Allotex’s TransForm™ platform is based on sterile human corneal tissue used for its structural properties as corneal tissue.
From the surgeon’s perspective, Prof. Aylin Kılıç explained why this area matters clinically:
“Hyperopia describes an eye shape where light is not focused on the same way as in a normal eye,” said Prof. Kılıç. “Especially younger hyperopic patients can represent an important gap in the treatment portfolio available to surgeons today. The physician-defined tissue geometries that were used could enable us surgeons to support millions of young patients with hyperopia. These observations help us understand how sterile allograft corneal tissue profiles behave safely in the cornea over time.”
Dr. Tanrıverdi explains further “Our data showed no significant complications such as graft rejection, epithelial ingrowth, tissue decentration, or corneal haze. The corneas were transparent. In many cases, the tissue was difficult to identify using our standard anterior-segment imaging as the placed tissue was well integrated into the host cornea.
“This is an important milestone for our TransForm™ human tissue platform,” said Michael Mrochen, CEO of Allotex. “We are excited to see long-term clinical observations on sterile corneal tissue profiles that we precisely processed according to geometries requested by the physicians involved in the study. For Allotex, the key point is the platform: sterile human corneal tissue can be prepared into defined specifications, placed in the cornea, and be safe over time.”
About Allotex
Allotex provides physician-defined sterile human corneal tissue through its TransForm™ Corneal Allograft platform. The platform is based proprietary laser technology to precisely process tissue geometries. Allotex is focused on building a scalable portfolio of sterile human corneal tissue profiles for corneal morphology applications.
Regulatory and Availability Statement
This announcement describes observations from a clinical follow-up study and Allotex’s tissue platform. It is not intended to announce a new product indication, to make a treatment claim, to imply medical-device status, or to imply that any product is approved, cleared, authorized, or licensed for any specific indication in any jurisdiction. TransForm™ is available in selected markets outside the United States and is not available for distribution in the United States. Product availability and permitted applications vary by country and are subject to applicable regulatory requirements.
Forward-Looking Statements
This announcement contains forward-looking statements regarding study interpretation, tissue-profile specifications, tissue processing, platform development, investor engagement, strategic partnerships, data generation, regulatory pathways, market development, and future applications. Actual results may differ. No assurance can be given that any product, application, market expansion, regulatory pathway, adoption, commercial success, or expected result will be achieved.
Tanrıverdi C, Karaca ZY, Keskin Perk FFN, Burke Z, Kılıç A. Allogenic Corneal Lenticule for Hyperopia: Five-Year Visual and Corneal Densitometry Outcomes in 20 Eyes. Presented as an ESCRS Free Paper; Topic: Refractive Corneal Inlays; Abstract ESCRS23-FP-2780.
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