The surgery was performed on 1 August at Wills Eye Institute in Philadelphia.
The dry AMD trials are being carried out to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD or Stargardt’s macular dystrophy (SMD) at 12 months, the study’s primary endpoint. Each trial has enrolled 12 patients, with cohorts of three patients in an ascending dosage format.
“Doubling the cell dosage in both our U.S. trials is an important step forward in our clinical programs,” said Robert Lanza, M.D., ACT’s chief scientific officer. “We anticipate continued progress and safety findings in both our U.S. trials as well as our concurrent European trial.”
“Dry AMD is a form of macular degeneration with no approved drug treatment available to date,” said Dr. Carl Regillo who led the surgery. ACT’s hESC-derived RPE cells could address the unmet medical need of combating dry AMD and other macular degenerations such as Stargardt’s disease. We are looking forward to analysing the safety and efficacy data.”