Allotex, a private company developing the TransForm Corneal Allograft (TCA) for the treatment of presbyopia with up comming market entry in Europe and initiating US FDA clinical trials The company was founded by Dr. David Muller and Professor Michael Mrochen in Boston, MA.
The TransForm corneal allograft for presbyopia has a diameter of 2.65 mm and a thickness of approximately 22 µm. It adds 2.50 D of near power in the central pupillary optic at the spectacle plane. Each inlay is prepared into about 100 blanks from sterile human donor corneas by means of special techniques. These blanks are measured with ultrahigh-resolution OCT and shaped into lenses using a specialized excimer laser. The refractive lenticules are then stored in recombinant human serum albumin and sterilized with electron-beam irradiation. (Accelerated electrons kill bacteria and fungi, making an electron beam ideally suited for sterilization and bioburden reduction.)
These shaped lenticules can be placed in a patient’s natural cornea under a standard LASIK flap with the aim of reducing or eliminating the need for wearing reading glasses. Unlike other similar devices the TCA has no biocompatibility issues because the natural collagen does not induce any immune response reactions. The efficacy & safety of this approach has been established by EU multicenter clincal trial. The 3 years clinical results of the TCA implantation for presbyopia are the founding basis for market entry in Europe. Further products include vision correction for hyperopia and keratoconus.