Abstract
Purpose :
Reformulated DA-6034(AJU-S56/GLH8NDE) would be a potential therapeutic candidate by ocular epithelial regeneration caused by the effects of mucin and tear secretion, goblet cell proliferation, and anti-inflammation. A phase 2 trial was designed to evaluate the clinical efficacy and safety of DA-6034 in patients with dry eye disease
Methods :
This was designed as a multi-center, randomized, double-blind, placebo-controlled clinical phase 2 study. The patients were randomized into three treatment groups and received each 1 drop at both eyes, three or six times a day with placebo or DA-6034 for up to 12 weeks(wks). The analysis to evaluate clinical signs and symptoms of dry eye disease included change from baseline in TCSS(Total Corneal Staining Score) at wk 4 as a primary endpoint and several variables including LGCS(Lissamine green conjunctival staining) and ODS(Ocular Discomfort Score) as secondary endpoints. Each changes from baseline were evaluated with the analysis of covariance(ANCOVA) for inter-group comparison. In addition, the safety such as adverse events were assessed at each visit.
Results :
In the per-protocol set, the change from the baseline of TCSS of three and six times a day group at wks 4 showed a significant difference(p=0.0398, p=0.0442) from placebo. In the full analysis set, the change from the baseline of TCSS of three times a day group at wk 8 (p=0.0460) and six times a day group at wk 12 (p=0.0176) showed a significant difference from placebo. To assess the improvement of symptoms of dry eye, both test groups at wk 4 showed a significant difference (p-value 0.0379, p-value 0.0164) from placebo in the change of ODS in the full analysis set. Six times a day group at wk 4(p=0.0014) and 12(p=0.0342) showed a significant difference from placebo in the change of LGCS for conjunctival recovery. In the safety assessment, there was no difference between each group.
Conclusions :
This study suggested that the treatment for 12 weeks of DA-6034 induced a significant reduction of TCSS and improvement of ODS or LGCS compared to placebo, which is clinically relevant results. DA-6034 was well tolerated with safety assessment compared to placebo. These findings provide the useful support for significant primary endpoints in a forthcoming pivotal study.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.