5. CONCLUSIONS
Upon detailed examination of the formulation, no toxic effect was found
in the different trials. Counting of micronucleus was normal, and the
overall irritation score showed no significant differences when compared
with the negative control. No presence of rapamycin in peripheral blood
was found and no genotoxic damage was noted. Furthermore, the different
histological, metabolic, biochemical and hematological evaluations
demonstrated no rapamycin-related harmful effects after subconjunctival
injection. Also, conservation of retina function after intravitreal
injection was demonstrated. The liposome-encapsulated rapamycin
formulation challenged in this article is safe to use in a dose range
from 40 to 440 µg/eye in the different animal models experimented by
subconjunctival or intravitreal injection. Furthermore, it shows great
potential to be proven in a human clinical trial.