Start-up ophthalmic device company Allotex announced the commencement of a European multicenter trial for its investigational TransForm allogenic refractive lenticules for the treatment of presbyopia.
The treatment was performed on Thursday by Arthur Cummings, MB ChB, FCS(SA), MMed(Ophth), FRCS(Edin), at the Wellington Eye Clinic in Dublin.
David Muller, PhD, Chief Executive Officer of Allotex, told Eyewire News that the procedure involved creating a thin corneal flap—100μm-120μm thick—then placing the lenticule on the flap bed, centering it on the pupil, and closing the flap.
“I am very excited about the possibility of using the Allotex TransForm lenticules for the treatment of presbyopia and other refractive indications,” Dr. Cummings said. “Being able to use allogenic lenses, which have been produced with very high precision, addresses the concerns that arise from the use of synthetic corneal implants. TransForm has the potential to address the ever-expanding market place for presbyopic treatments.”
The Transform lenticule is created by using a custom excimer laser system to precisely shape lenticules made from donor corneal tissue that is procured and processed under Eye Bank Association of America (EBAA) standards. The human corneal tissue can be added intrastromally under a flap or as an onlay, on top of Bowman’s membrane but under the epithelium.
Although there has been recent interest in the transplanting of single-incision small-incision lenticule extraction (SMILE) lenticules for this same purpose, the screening requirements for donor corneal tissue cannot be generally met at a surgery center, Dr. Muller said. The lenticules undergo a process that makes them stabile with up to 2 years of shelf life and are packaged in a convenient manner for the surgeons use.
In earlier work, Aylin Kiliç, MD, of Medipol University, Istanbul, Turkey, demonstrated the safety and efficacy of the TransForm procedure while showing that the case could be completed, from start to finish, in only 15 minutes, Dr. Muller said.
The trials are being expanded to other countries including the United Kingdom, Belgium, Austria, France, and Switzerland. In addition to corneal inlays, the study will be expanded to include corneal onlays, placed on Bowman’s membrane, and hyperopia inlays, according to Allotex. These studies will provide data to support the company’s eventual FDA application for clinical studies in the US.