Immunogenicity evaluations
Anti-EGF antibodies were determined for assessment of immunogenicity
from serum samples at the scheduled times; prior to following the rhEGF
eyedrops administration at week 4 in the SAD study and prior to
following the rhEGF eyedrops administration at week 1, 2, and 6 in the
MAD study. The anti-EGF antibodies were determined using validated
ELISA. The confirmation of specificity used a floating cut point.