Abstract
Purpose :
Recovery following DSO can be affected by many variables, including, but not limited to, size of descemetorhexis, comorbid diabetes, and concurrent cataract procedure. We reviewed the data from the STORM Study (TTHX-002) to determine the effect of these variables on time to recovery to BCVA of 20/40 or better.
Methods :
Study TTHX-002 was an open-label study of TTHX1114 (an engineered FGF1) administered as an adjunct to DSO in FECD patients. This study demonstrated a dose-dependent acceleration of recovery based on both BCVA and corneal edema. Since efficacy was similar in the 2 high-dose groups (n=50, per protocol) these data were pooled and recovery rates in subset populations were analyzed. 45/50 (90%) of eyes had recovered to BCVA 20/40 or better at the time of data cut-off.
Results :
Time to 20/40 (weeks) was faster in subjects with smaller DSO (4mm = 4.5, >4.5 to ≤4.5mm = 6.7, ≥5mm = 6.6) and slower in subjects with diabetes (7.7 compared to 5.2 in subjects without diabetes). These trends in faster recovery were also seen when evaluated by corneal thickness, with corneal edema at Day 28 lower in subjects with smaller DSO (4mm = 637.6, >4.5 to ≤4.5mm = 743.2, ≥5mm = 808.8) and corneal thickness was slightly higher in in subjects with diabetes (719.8 µm compared to 702.9 in subjects without diabetes).
No significant differences were noticed in the recovery of subjects undergoing combination cataract surgery compared to those undergoing DSO alone
Conclusions :
Smaller descemetorhexis was associated with faster recovery while comorbid diabetes appeared to delay recovery. Visual outcomes for patients undergoing DSO did not appear to be adversely affected by concurrent cataract surgery. Although these numbers are small, comorbidity and planned combination procedures should be taken into consideration when designing trials in DSO.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.