Pharmacokinetics
After administration of rhEGF eyedrops, the mean serum EGF concentration
showed numerous peaks, but it did not change compared to those of
baseline and placebo, while the mean tear EGF concentrations increased
compared to those of baseline and placebo in SAD and MAD studies (Figure
1, Figure 2). rhEGF eyedrops were rapidly absorbed with tear
Tmax at ranges of 0.18-0.2 and 0.18–0.27 hours in SAD
and MAD studies, respectively (Table 3). Then, the mean tear EGF
concentrations became similar compared to those of baseline and placebo
after 4 hours of administration in SAD and MAD studies. Tear
Cmax and AUC0-12h increased by dose in
SAD and MAD studies. However, Tear C12h did not change
by rhEGF eyedrops in SAD and MAD studies.