Allotex Announces 3-Year Results of Allogeneic Inlays for the Treatment of Hyperopia and Presbyopia

Allotex, the maker of implantable allogeneic corneal inlay technology, reported on the completion of 3-year follow-up on the use of its TransForm inlay for the treatment of patients with hyperopia requiring corrections high as +8 D. This study was a precursor to the company’s completed study using the Transform inlay for the treatment of presbyopia, thus restoring unaided reading vision to that study group.

According to Allotex, 3-year results in the hyperopia study demonstrated reduction of refractive error, safety, and stability:

• Corneas were clear, and the implant was not visible using optical or OCT technology
• The refractive change was shown to be stable up to 3 years

Results from the presbyopia study showed clinically significant improvement in visual performance, including:

• Average uncorrected near visual acuity improved by 5 lines (at 40 cm) in the treated eye
• 98% of patients achieved uncorrected near visual acuity (UCNVA) of 20/40 or better and 80% of patients achieved UCNVA of 20/25 or better at 6 months in the treated eye
• No loss of in binocular distance vision

"The outstanding clinical results that we have seen with our use of the TransForm implant clearly demonstrate the exciting potential for allogeneic refractive implants," Aylin Kilic, MD, Associate Professor and Director of Refractive Surgery at MediPol Hospital in Istanbul, said in a company news release. "The procedure is quick, simple, and provides immediate patient satisfaction. Patients are thrilled that they can read their phones right after surgery. Our 3-year results show that the safe use of allogeneic material far surpasses the prior attempts to use synthetic material for cornea."

About the TransForm Allogeneic Corneal Inlay

The TransForm Inlay is placed in the cornea in a 5-minute procedure. The TransForm is produced using ethically sourced human corneas which have been processed using Allotex patented technology. In the treatment presbyopia, the implant is 2.6 mm in diameter, 22 um central thickness, and precisely shaped using patented laser technology. In the case of hyperopia inlays, Allotex has increased the size to 6.0 mm and up to 150 um thick, which further demonstrates the safety of the use allogeneic corneal implants.