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lasers

02/16/12 8:58 AM

#40687 RE: lasers #40686


The Food and Drug Administration’s (FDA) protocol for our surgeries, as you are also likely aware, involves a course of immune suppression before and for a period of time after the transplant, and a patient’s ability to tolerate this without other adverse effects is a critical factor in inclusion in the study. The extremely poor visual acuity requirements in the FDA protocol result in a decidedly elderly patient population (with patients typically being 77 years old or so at the youngest). When that factor is combined with the requirementofan intact Bruch’s Membrane, and the general health-related restrictions mentioned above, it makes for a more challenging patient screening process in the dry AMD trial relative to that for the SMD trial.

That being said, I am pleased to inform you that we are currently in the advanced stages of screening several more clinical trial candidates and are very confident that we will soon be able to treat two additional Dry AMD patients, rounding out the first cohort in the AMD trial.