Clinical Efficacy Of Topical 0.1% Tacrolimus In Patients With Corneal Neovascularization: A Prospective, Multicenter, Randomized Controlled Trial
Published 2026 - 44th Congress of the ESCRS
Reference: POCOR555 | Type: Free paper | DOI: 10.82333/4y94-p509
Authors: Myung-Sun Song* 1 , Nahyun Park 1 , Yea Eun Lee 1 , Chung Min Lee 1 , Jeewon Han 1 , Alison Hong 2 , Youngsub Eom 3 , Ikhyun Jun 4 , Hun Lee 5
1Ophthalmology,Asan Medical Center,Seoul,Korea, Republic Of, 2Ophthalmology,George Washington Univetsity,Washington DC,United States, 3Ophthalmology,Korea University College of Medicine,Seoul,Korea, Republic Of;YES Eye Clinic,Seoul,Korea, Republic Of, 4The Institute of Vision Research, Department of Ophthalmology,Yonsei University College of Medicine,Seoul,Korea, Republic Of;The Corneal Dystrophy Research Institute,Yonsei University College of Medicine,Seoul,Korea, Republic Of, 5Ophthalmology,Asan Medical Center,Seoul,Korea, Republic Of;Center for Cell Therapy,Asan Medical Center,Seoul,Korea, Republic Of
Purpose
To evaluate the effect of topical 0.1% tacrolimus on corneal neovascularization (CoNV) and compare it with 1% prednisolone acetate.
Setting
A multicenter, evaluator-masked, randomized controlled trial
Methods
Patients with CoNV were randomized to receive either 0.1% tacrolimus (Alymus, Taejoon Pharmaceutical Co., Ltd, Seoul, Korea) or 1% prednisolone acetate (Pred Forte, Allergan Inc., Irvine, CA). From baseline (V1) to week four (V2), eye drops were administered four times daily, followed by twice daily until week eight (V3). Clinical assessments included CoNV grade, visual acuity, intraocular pressure, and ocular surface staining scores. A linear mixed model was used to investigate the effects of 0.1% tacrolimus on CoNV.
Results
A total of 46 patients (Tacrolimus group, n=24; Prednisolone group, n=22) were analyzed. No significant differences in demographics and baseline clinical parameters between the groups were observed. In both groups, CoNV grade decreased significantly from V1 to V2 (Tacrolimus group: from 2.025 ± 0.162 to 1.733 ± 0.162, P = 0.003; Prednisolone group: from 1.852 ± 0.168 to 1.625 ± 0.168, P = 0.035), but the changes did not vary significantly between the two groups (P = 0.688). No significant change in CoNV grade was observed from V2 to V3 in either group (both P > 0.05). From V1 to V3, a significant decrease in CoNV grade was observed in the tacrolimus group only (from 2.025 ± 0.162 to 1.697 ± 0.164, P = 0.019).
Conclusions
Both 0.1% tacrolimus and 1% prednisolone acetate demonstrated efficacy in reducing CoNV during the first month. The therapeutic effect was significantly sustained up to 8 weeks in the tacrolimus group, suggesting that 0.1% tacrolimus may represent an effective therapeutic alternative for patients with CoNV.