Abstract
Purpose :
TTHX1114 is an FGF1 analog with protective, proliferative and pro-migratory properties for corneal endothelial cells (CEnCs). Cataract surgery is known to damage CEnCs.. This study sought to analyze data from the STORM study to evaluate whether TTHX1114 protected endothelial cells from damage due to cataract surgery in FECD patients undergoing DSO
Methods :
STORM was an open-label, nonrandomized, Phase 2 dose ranging study of TTHX1114 in FECD patients undergoing DSO. In STORM, 46% of eyes underwent cataract surgery in combination with DSO. Subgroup analysis was used to determine if the group that received combined cataract surgery had more severe edema, worse BCVA or any other signs that the cataract surgery had the expected effect of endothelial damage
Results :
Across all patients, TTHX1114 produced a dose-dependent improvement in corneal edema and BCVA following surgery. The proportion of patients with complete resolution of corneal edema in the high dose (100ng at time of surgery with or without additional post-surgical doses) groups at Day 28 was similar in patients with DSO only vs those with DSO+cataract (25.9% vs 17.4%) as was the mean central corneal thickness (705+/-174 um vs 700+/-148 um). The proportion of patients recovering good BCVA (69 letters or better) was also similar between these groups, with 58% of the DSO only patients recovering to 69 letters or better at day 28 vs 61% of the DSO+cataract patients. In the low dose (50ng at time of surgery) group, central corneal thickness at 14 days was numerically worse in the DSO+cataract group (961+/-77) than the DSO only group (828+/-108um) but this was not statistically significant, and the two groups are comparable at all later time points
Conclusions :
Cataract surgery when combined with DSO did not worsen postsurgical edema or adversely impact BCVA recovery. These data support the potential use of TTHX1114 for the control of postsurgical edema in high risk patients undergoing cataract surgery
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.