AAVL> ...neither the P1 or P2A for AVA-101 are targeting naive patients so not sure VA gains >15 letters is as important. The 8 subjects in the P1 had an avg 18 prior anti-VEGF injections.
P2A endpoints...
The primary endpoint is safety and secondary endpoints include retinal thickness, visual acuity and the need for rescue injections with anti-VEGF therapy (Lucentis).
Also the mean change in VA was +7.5 letters in the combined high/low dose arms vs. -3.5 in the Lucentis arm after 52 wks. The 7.5 letter gain compares favorably to the Lucentis P1 where the mean gain was only 5.5 letters in 24 wks in naive patients.
Also, rescue injections were reduced 89% in the AVA-101 arms.
AI
