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

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 -test was performed to calculate -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 (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 (=0.03) and -10.1 (10.6) points at 5 minutes post-dose (<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.