Abstract
Purpose :
A major contributor to dry eye disease (DED) is increased inflammation activated through tumor necrosis factor (TNF), one of the key cytokines that leads to a maladaptive cycle of inflammation.1, 2 A wide range of data on TNF inhibitors, both systemic and topical, support the potential of this mechanism of action in the treatment of DED.2, 3 A Phase 3 study evaluated the efficacy and safety of a topical TNF inhibitor, tanfanercept ophthalmic solution 0.25%, for DED.
Methods :
In a randomized, double-masked, multicenter Phase 3 study, 260 subjects received tanfanercept 0.25% or vehicle twice daily for 8 weeks following a 2-week vehicle run-in. The study measured co-primary endpoints: mean change from baseline in central corneal staining score (CCSS) and eye dryness score (EDS) at week 8. The secondary endpoints included mean change from baseline in Schirmer tear test (STT) and safety endpoints. Additionally, a post hoc analysis was conducted on STT responders, the percentage of subjects achieving a ≥10-millimeter increase in STT scores from baseline.
Results :
While there was a general decrease in both tanfanercept and vehicle groups for CCSS and EDS, there was no statistically significant difference between the treatment groups. Tanfanercept 0.25% did demonstrate a statistically significant improvement (p<0.005) in the secondary endpoint of mean change from baseline to week 8 in STT, relative to vehicle. Furthermore, the proportion of STT responders as assessed at week 8 was statistically significant (p=0.01) in the tanfanercept 0.25% group (13%) relative to vehicle (4%). Further corroborating this effect, a post hoc analysis of a previous phase 3 study (VELOS-2) also demonstrated that when the subset of subjects that met VELOS-3 inclusion criteria were examined, those receiving tanfanercept 0.25% achieved a greater improvement from baseline in STT compared to those who received vehicle at week 8 (p=0.005). Tanfanercept was well tolerated and the safety findings from VELOS-3 were consistent with those of the previous studies without any significant new adverse events observed.
Conclusions :
Tanfanercept ophthalmic solution 0.25% confirmed safety and efficacy in a Phase 3 study, improving tear volume in subjects with DED.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.