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.