Positive outcomes in clinical evaluation of bioengineered cornea
Symptomatic improvement after two years of follow-up
Findings from a Phase I study suggest that a fibrin-agarose-based anterior lamellar corneal substitute is safe as a treatment for severe trophic corneal ulcers or its sequelae, reported Miguel Gonzalez-Andrades, MD, at the annual meeting of the Association for Vision and Research in Vancouver, Canada.
Clinical evaluation of the corneal substitute has now advanced into a randomised Phase IIA study including amniotic membrane transplantation as a control arm.
The Phase I study enrolled five patients who had severe corneal ulcers refractory to conventional treatment or sequelae of previous ulcers. During the 24-month follow-up, there were no serious treatment-related adverse events. Improvements in the severity of superficial punctate keratopathy, corneal epithelial defect, corneal neovascularisation, keratinization, and conjunctival hyperemia, were seen in some or all patients. Subjectively, all patients reported symptomatic improvement and said they would repeat the procedure.
“Only two patients had improvement in visual acuity, but these were very severe cases and hopefully we can better evaluate efficacy in the next study phase,” said Dr Gonzalez-Andrades, University of Granada, Granada, Spain.