Translation of hyaluronic acid-based vitreous substitutes towards current regulations for medical devices.
Andre SchulzAnja GermannWerner R HeinzMelanie EngelhardHelge MenzAnnekatrin RickmannIna MeiserSascha WienSylvia WagnerKai JanuschowskiPeter SzurmanPublished in: Acta ophthalmologica (2022)
The present study demonstrates the successful transferability of the crucial synthesis steps of hyaluronic acid-based hydrogels into a routine, GMP-compliant production process while achieving the optical and viscoelastic properties, biocompatibility and purity required for their clinical use as vitreous substitutes.