MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED, PARALLEL-GROUP PHASE 3 FDA STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EPITHELIUM-ON CORNEAL CROSS-LINKING IN SUBJECTS 8 TO 45 YEARS OF AGE WITH KERATOCONUS

To report the current status and ongoing recruitment of the US based Epion Therapeutics, multicenter, sham controlled Phase 3 trail for epithelium-on corneal crosslinking using a novel Riboflavin formulation containing sodium iodide and a novel UVA delivery capable of simultaneous, bilateral treatments in subjects with keratoconus between the ages of 8 - 45 

24 study sites based in the US with a combination of academic and private practice settings.  All sites are acknowledged corneal practices with crosslinking experience.  

Two studies of 400 subjects each will be enrolled in an active / sham controlled study in a 1/1 ratio.  Subjects will be treated on diagnosis, without requiring documenting progression.  Subjects in the active arm will receive concentrated riboflavin with sodium iodide for a 30 minute saturation period followed by 20 minutes of UVA treatement at 4 mW/cm2 in a 15 second on/off cycle.  Subjects in the sham arm will receive placebo followed by a green light application in a similar pattern. Contact lens wearing subjects need to discontinue their lens and show documented stability prior to treatment.  Subjects, post treatement, are seen on day 1, 1 week, 1, 3, 6 & 12 months.  Subjects showing disease progression by either loss of visual acuity and/or tomographic progression may be treated / retreated with active drug after 3 months.  The primary efficacy endpoing is improvement inf best spectacle corrected distance visual acuity (BSCDVA) in actively treated subjects compared to sham controls at 12 months.  

Recruitment for the Phase 3 study began in October, 2023.  Interim analysis as of Feb, 2024 will be reported.

Epithelium on corneal crosslinking offers a significantly improved risk/benefit ratio without disrupting the corneal epithelium and is associated with a reduction in haze, scarring and pain allowing a more rapid return to pre-operative levels of activity.  The improved risk/benefit ratio and the reduction in the post-operative down time, allows for simultaneous, bilateral treatments.  The improved risk/benefit ratio allows treatment on diagnosis prior to vision loss with the goal of preserving or improving visual function.