Patient Experience with ABBV-444, a Proof-of-Concept Study for a Novel Artificial Tear with Trehalose and Sodium Hyaluronate for Dry Eye Symptoms
Milton M Hom,1 Omar Ladhani,2 Zuoyi Zhang,2 Haixia Liu,3 Sadhana Sonparote,2 Charlotte C Dancey3 1Canyon City Eyecare, Azusa, CA, USA; 2AbbVie, North Chicago, IL, USA; 3AbbVie, Irvine, CA, USACorrespondence: Charlotte C Dancey, AbbVie, 2525 Dupont Drive, Irvine, CA, USA, Tel +1 (949) 386 6594, Email...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2025-02-01
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| Series: | Clinical Optometry |
| Subjects: | |
| Online Access: | https://www.dovepress.com/patient-experience-with-abbv-444-a-proof-of-concept-study-for-a-novel--peer-reviewed-fulltext-article-OPTO |
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| Summary: | Milton M Hom,1 Omar Ladhani,2 Zuoyi Zhang,2 Haixia Liu,3 Sadhana Sonparote,2 Charlotte C Dancey3 1Canyon City Eyecare, Azusa, CA, USA; 2AbbVie, North Chicago, IL, USA; 3AbbVie, Irvine, CA, USACorrespondence: Charlotte C Dancey, AbbVie, 2525 Dupont Drive, Irvine, CA, USA, Tel +1 (949) 386 6594, Email charlotte.dancey@abbvie.comPurpose: 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.Keywords: artificial tears, carboxymethylcellulose, dry eye disease, trehalose |
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| ISSN: | 1179-2752 |