Purpose. To study the effect of a novel protease in the development and pro
gression of corneal ulceration secondary to alkali burning. Methods. By usi
ng a 4N alkali burn model of corneal ulceration in rabbits, the effects and
efficacy of topical application of a novel protease (PHM-101) capable of d
egrading metalloproteinases was studied for 28 days of treatment and 7 days
off treatment for its effect on corneal ulceration and recurrent erosion.
Results. At day 28, both the protease- and placebo-treated groups had diffe
rent numbers of eyes showing reepithelialization [nine (45%) of 20 and six
(33%) of 18, respectively]. By day 35 the protease-treated group had signif
icantly fewer recurrent epithelial defects [two (13%) of 15 vs. eight (61%)
of 13; p = 0.02]. Similarly, at day 35 the protease treated group showed s
ignificantly less corneal ulceration [two (13%) of 15 vs, six (46%) of 13;
p = 0.02], and those ulcers were of a lesser severity (three units vs. 17.7
6 units). No difference was found in the degree of stromal edema or neovasc
ularization, nor was there any difference in histopathologic characteristic
s of inflammatory cell infiltration and corneal scarring. Conclusion. We co
nclude that this novel protease is efficient in reducing recurrent corneal
epithelial defects and stromal ulceration after alkali burning.