Multicenter, Randomized, Sham-Controlled, Phase 3 Study To Evaluate Epithelium-On Cxl In Keratoconus Subjects 8 To 45 Years
Published 2025 - 43rd Congress of the ESCRS
Reference: PP16.05 | Type: Free paper | DOI: 10.82333/pnr7-gh76
Authors: Francisco J. Castro* 1 , David Mingo Botin 2 , Francisco Arnalich Montiel 2 , Galadriel Giménez Calvo 1 , Sara Marquina Martín 1 , José M Larrosa Poves 1 , Martin Puzo Bayod 1
1Ophthalmology. Unidad de cirugía facorefractiva (UFR),Hospital Universitario Miguel Servet,Zaragoza,Spain, 2Hospital Universitario Ramon y Cajal,Madrid,Spain
Purpose
Corneal crosslinking (CXL) is standard of care for treating ectatic disease. While epithelium-off CXL is effective, it is associated with slow recovery and occasional severe complications. Epithelium-on CXL has potential to limit complications and provide a more rapid recovery. To date, however, there is no USA FDA approved epithelium-on technique. Presenting interim results of Epion Phase 3 study.
Setting
24 US based investigational sites with a mix of both private practive and academic centers.
Methods
Two (400 subjects each), placebo-controlled Phase 3 trials (Apricity A & B trials) commenced late 2023 to study a unique riboflavin with addition of sodium iodide (IP - investigational product) in ages 8 - 45 with 1:1 randomization. Enrollment based on standardized tomographic criteria with treatment on initial diagnosis. IP is applied every two minutes for 30 minutes with a unique corneal sponge to maintian continued corneal contact. UVA is applied for 20 minutes cycling every 15 seconds. No additional drug is applied during UVA application. Bilateral, simultaneous treatment performed if both eyes meet entrance criteria. Subjects will be followed for 12 months with a crossover at the end of the study in sham treated subjets.
Results
As of Feb, 2025, 719 of 800 were enrolled (90% of full enrollment). 72% male / 28% female, ages 11 – 45, with 15% below the age of 21. 72% of subjects opted for bilateral, simultaneous treatments. Pre-operative BSCDVA from 20/20 to 20/800 (38 % ≥ 20/40). All subjects showed complete stromal saturation ≥ 3.5 (scale 1 – 5), with < 0.5% of subjects requiring an additional 5-minute application, without need for additional drops or drops during UVA application. No supplemental oyxgen, goggles, or epitelial loosening agents are utilized. To date, all sham treated subjects have opted for active cross-over treatment after their 12-month exam (Enrollment will be completed prior to ESCRS and all results will be updated.)
Conclusions
Epithelium-on CXL offers potential advantages in both safety and comfort. The improved safety profile of epithelium-on CXL would also support earlier intervention in the hope of preventing visual loss at the earliest possible stage.