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).