TOPLINE

In a pooled analysis of two 12-week trials in patients with dry eye disease, an investigational eye drop called reproxalap eased dryness and discomfort more than a vehicle drop, with benefits observed as early as the first week. Irritation at the drop site was the most common side effect, reported by about half of those on reproxalap, and no serious treatment-related problems were reported.

METHODOLOGY

• Researchers pooled data from a phase 2 trial and two arms of a phase 3 trial to compare the symptom-relieving efficacy and safety of 0.25% reproxalap eye drops with those of vehicle in patients with dry eye disease.
• After a 2-week run-in period on vehicle drops, 417 participants were randomly assigned to receive either reproxalap or vehicle. The doses were scheduled four times daily for 4 weeks and then twice daily for 8 weeks, with visits conducted at weeks 1 and 2 and every 2 weeks afterward through week 12.
• At every visit, participants rated their eye dryness and discomfort on a scale of 0-100 (0 meaning no discomfort and 100 meaning maximal discomfort), giving one overall score for both eyes.
• The symptoms were analyzed in 335 participants (mean age, 64.2 years; 74.6% women) who scored 3 or higher on  a separate scale of 0-5 for dryness at baseline.
• Safety was tracked through reported side effects, vision testing, and exams of the eyes at each visit, along with eye pressure measurements and dilated eye exams at screening and week 12.

TAKEAWAY

• Patients on reproxalap reported greater improvements in dryness of the eyes than those on vehicle at every visit from week 1 through week 12. At week 1, mean scores fell by about 9 points in the reproxalap group and 2 points in the vehicle group, and at week 12, the drops were about 20 and 12 points, respectively.
• Modeling of changes across the week 1 to week 12 visits showed that reproxalap was associated with greater reductions in dryness and discomfort scores than vehicle, by about 8.5 and 7.7 points, respectively, on a 0-100 scale (nominal P < .001 for both).
• Irritation at the drop site was the most common side effect, affecting 52.2% of patients on reproxalap compared with 0.5% of those on vehicle; most cases (82.4%) were mild, and the rest were moderate.

IN PRACTICE

In patients with dry eye disease, "[r]eproxalap may be a therapeutic option," the researchers reported.

SOURCE

The study was led by John D. Sheppard, Virginia Eye Consultants in Norfolk, Virginia. It was published online on September 28 in Ophthalmology and Therapy.

LIMITATIONS

The pooling was not planned in the original protocols, and both trials compared reproxalap only with vehicle. The trials also differed slightly in how they were conducted. Because participants were randomly assigned before the symptom-analysis group was selected, the two arms ended up with slightly different numbers of participants.

DISCLOSURES

The study was funded by Aldeyra Therapeutics. Four authors were employees of AbbVie and may have owned stock or stock options. Two authors were employees of Aldeyra. The other three authors disclosed consulting for AbbVie, two of them also for Aldeyra, as well as for other companies. One reported equity in other eye-care companies, and another reported research funding from other organizations.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.