Patient Experience with ABBV-444, a Proof-of-Concept Study for a Novel Artificial Tear with Trehalose and Sodium Hyaluronate for Dry Eye Symptoms.

Abstract

Purpose: Dry eye disease (DED) causes discomfort and potential damage to the surface of the eye, commonly managed with artificial tears. We assessed symptom relief, tolerability, and patient experience of a novel carboxymethyl-cellulose-based artificial tear formulation with trehalose and sodium hyaluronate (ABBV-444) in patients with DED.

Methods: This open-label, single-arm, single center study enrolled adult patients with baseline Ocular Surface Disease Index (OSDI) scores of ≥18 and ≤65. Patients were instructed to use ABBV-444 as often as needed but at least twice a day for 30 days. The primary endpoint was change from baseline in OSDI score at Day 30. Secondary endpoints were onset of action (change from baseline in current symptom survey [CSS] visual analog scale [VAS] scores over 5 minutes post administration on Day 1) and patients' experience (change from baseline in Patient Eye Drop Experience [PEDE] survey VAS scores at Day 30). Outcomes were assessed in the per-protocol (PP) population using descriptive statistics. A paired t-test was performed to calculate P-values.

Results: A total of 34 patients were included in the PP population. DED severity, measured by OSDI, significantly decreased by a mean (standard deviation; SD) score of 6.8 (15.0) points from baseline to Day 30 (P=0.006). Patients showed significant symptom improvement as early as 30 seconds after application, with mean (SD) CSS changes from baseline of -3.3 (10.3) points at 30 seconds (P=0.03) and -10.1 (10.6) points at 5 minutes post-dose (P<0.001). No adverse events were reported. PEDE scores averaged between 76.4 (36.7) and 85.7 (21.0) at Day 30.

Conclusion: Continuous daily treatment with ABBV-444 reduced DED symptom severity over 30 days and demonstrated rapid onset of action within 30 seconds post administration. These results suggest that ABBV-444 is a viable therapy for DED symptoms and support further investigation of longer-term treatment in multicenter trials.