Reproxalap Eye Drops Improve Dry Eye Symptoms: Study
A pooled analysis of two 12-week trials found that investigational reproxalap 0.25% eye drops significantly improved eye dryness and discomfort compared with vehicle, with benefits evident as early as week 1. Across 12 weeks, reproxalap produced greater reductions in symptom scores, although drop-site irritation was common, occurring in 52.2% of treated patients, mostly mildly. No serious treatment-related adverse events were reported. The study was published in the Ophthalmology and Therapy journal by John D. and colleagues.
In order to assess the effectiveness and the safety profile of reproxalap, the researchers combined data coming from similar arms of two 12-week double-masked, parallel-group, randomized and controlled clinical trials with vehicle. Patients included in these trials received topical ocular administration of 0.25% reproxalap or vehicle, 4 times per day for the first 4 weeks, and then twice a day for the last 8 weeks.
The primary endpoints related to symptoms (oculardryness and ocular discomfort) were assessed according to 0 to 100 visual analogue scale (VAS) for oculardryness (VAS-OD). This assessment was done in patients from the intent to treat oculardryness (ITTOD)population with scores ³3 at baseline for Ora Calibra®Ocular Discomfort& 4-symptom questionnaire. The safety measures were taken into account in all patients receiving treatment.
Key findings:
- When the data was pooled among 417 total participants (207 reproxalap, 210 vehicle) and 335 ITTOD participants (167 reproxalap, 168 vehicle), clear superiority was demonstrated in terms of evaluations at each time point.
- Reproxalap had achieved significant superiority in terms of the ocular dryness score versus vehicle in terms of statistical differences at every measured time point since week 1.
- There was a least-squares mean difference of −8.5 (95% CI −12.6 to −4.5, p < 0.001) in terms of overall change from baseline from week 1 through week 12.
- The same level of significance was achieved regarding the ocular discomfort score where reproxalap achieved a least-squares mean difference of −7.7 (95% CI −11.8 to −3.5, p < 0.001) in comparison with vehicle at 12-week study duration.
- Reproxalap was tolerable during 12 weeks of the study.
In summary, pooled clinical trial data show that 0.25% reproxalap results in rapid and long-lasting relief of dry eye symptoms and a favorable safety profile. It is important to note that the conclusions drawn from this study highlight that reproxalap is a rapidly acting and novel treatment for dry eye disease.
Reference:
Sheppard, J.D., Nichols, K., Starr, C.E. et al. Effect of Reproxalap Treatment on Dry Eye Disease Symptoms: Analysis of Pooled Data From Two Randomized, Vehicle-Controlled, 12-Week Clinical Trials. Ophthalmol Ther (2026). https://doi.org/10.1007/s40123-026-01503-0
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