Safety
rhEGF eyedrops were well tolerated in all dose groups in SAD and MAD
study. There were 6 adverse drug reactions (ADRs) by 5 subjects treated
with rhEGF eyedrops and 2 ADRs by 2 subjects treated with placebo in SAD
study, and 6 ADRs by 5 subjects treated with rhEGF eyedrops and 5 ADRs
by 4 subjects with placebo in MAD study, respectively (Table 1). All
ADRs were mild and transient, and there were no serious adverse events.
The most common ADR was corneal erosion probably resulted from tear
sampling procedure, which was reported 6 times by 6 subjects and 8 times
by 7 subjects in SAD and MAD study, respectively. There were no
significant differences in the incidences of ADRs in SAD (p -value
0.7660. Fisher’s exact test) and MAD (p -value 0.4631. Fisher’s
exact test) studies, respectively.
There were no clinically significant findings for vital signs, physical
examinations, and ECG. In addition, there were no changes in ophthalmic
examinations after the administrations of rhEGF eyedrops (Supplementary
Table 2).