Approval of retinal gene therapies in the US and Europe based on visual acuity and microperimetry

Microperimetry provides a sensitive and repeatable measure of retinal function, with mean sensitivity across the macula or central 16-point region offering a more reliable metric than single-point requirements recommended by the FDA. A 2.5dB gain in mean sensitivity is equivalent to a 13-letter increase in low-luminance ETDRS representing a clinically significant change and aligning closely with regulatory standards.