SAFETY AND EFFICACY OF STEM CELL FORTIFIED EYE DROPS IN CORNEAL ULCER TREATMENT

Abstract

Purpose: To evaluate the therapeutic efficacy of stem cell-derived Fortified Drops (ACE Orbit™) in managing persistent and regular corneal ulcers unresponsive to conventional treatment. Methods: This prospective, interventional study included 33 eyes—10 with persistent ulcers (>2 weeks) and 23 with regular ulcers (<2 weeks)—treated with bioactive peptide-based Fortified Drops thrice daily for 30 days. Clinical assessments included epithelial closure, visual acuity, corneal clarity via OCT, pachymetry, and levels of inflammatory biomarkers (MMP-9 and IL-1β). Results: Complete epithelial healing occurred in 80% of persistent ulcers and 100% of regular ulcers (p= 0.009). Group 2 exhibited significantly better outcomes in corneal clarity (p < 0.001), faster healing (15.2 ± 3.2 vs. 22.5 ± 4.5 days, p < 0.001), and greater reductions in MMP-9 and IL-1β levels (p= 0.045 and p=0.027, respectively). Visual acuity and central corneal thickness improved in both groups, though not statistically significantly between them. Mild irritation was the only common adverse effect; one case of perforation occurred in Group 1. Conclusion: Fortified Drops sign-ificantly enhanced corneal healing, reduced inflammation, and improved corneal clarity, particularly in regular ulcers. Although persistent ulcers showed slower and less complete healing, the drops demonstrated promising regenerative potential and a favorable safety profile. These findings support the use of Fortified Drops as a non-invasive, adjunctive treatment for challenging corneal ulcer cases.