We evaluated the efficacy of topical cyclodextrin-encapsulated FK-506
in the prevention of experimental corneal allograft rejection. Two wee
ks after inducing corneal inflammation and neovascularization with 8-0
silk sutures, 23 albino rabbits received a unilateral 8-mm diameter c
entral penetrating corneal allograft from pigmented donors. Rabbits we
re randomly assigned to no treatment (eight eyes), topical cyclodextri
n four times daily for 28 days (seven eyes), or topical FK-506 0.3 mg/
ml in a cyclodextrin suspension (eight eyes) four times daily for 28 d
ays. Grafts were examined daily for degree of inflammation, neovascula
rization, edema, and signs of rejection for up to 100 days. Seven of e
ight (88%) untreated grafts and five of seven (71%) cyclodextrin-treat
ed grafts rejected at a median of 3 weeks after transplantation, where
as only two (25%) of eight FK-506-treated treated grafts rejected and
did so at a significantly longer interval (p < 0.005). Topical FK-506
prevents or delays corneal allograft rejection after experimental corn
eal transplantation.