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Peer-reviewedCC BY-NCOphthalmology and Therapy

Effect of Reproxalap Treatment on Dry Eye Disease Symptoms: Analysis of Pooled Data From Two Randomized, Vehicle-Controlled, 12-Week Clinical Trials

  • John D. Sheppard1
  • Kelly Nichols2
  • Christopher E. Starr3
  • Amber Lewis4
  • Desiree Owen4
  • Cathy Zhao4
  • Mei Li4
  • Bill Cavanagh5
  • Todd C. Brady5
5 affiliations
  1. 1Virginia Eye Consultants
  2. 2University of Alabama at Birmingham
  3. 3Weill Cornell Medicine, New York-Presbyterian Hospital
  4. 4AbbVie Inc.
  5. 5Aldeyra Therapeutics, Inc
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Abstract

Introduction Reproxalap is a novel reactive aldehyde species inhibitor. Pooled data from two clinical trials were used to evaluate effects on symptoms and safety of reproxalap treatment versus vehicle in participants with dry eye disease (DED). Methods Data were pooled from identically designed arms of two 12-week, randomized, vehicle-controlled, double-masked, parallel-group clinical trials comparing topical ophthalmic reproxalap 0.25% with vehicle, each dosed four times daily for 4 weeks then twice daily for 8 weeks, in participants with DED. Symptoms of ocular dryness and ocular discomfort were assessed using a visual analog scale (0–100) in the intent-to-treat ocular dryness (ITTOD) population (prespecified for the symptom primary endpoint analysis in each trial) of participants with a baseline ocular dryness score of ≥ 3 on the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire. Safety parameters were evaluated in all treated participants. Results A total of 417 participants received study treatment (207 reproxalap, 210 vehicle), and 335 participants were included in the ITTOD population (167 reproxalap, 168 vehicle). The mean improvement from baseline in both ocular dryness and ocular discomfort scores was greater with reproxalap than vehicle at each timepoint (nominal p < 0.05). The least-squares mean difference (reproxalap − vehicle) in overall change from baseline from week 1 to week 12 was −8.5 (95% CI −12.6 to −4.5, p < 0.001) for ocular dryness score and −7.7 (95% CI −11.8 to −3.5, p < 0.001) for ocular discomfort score. The most common adverse event was mild instillation site irritation. There were no serious treatment-related adverse events. Conclusions Reproxalap reduced ocular dryness and discomfort symptoms compared with vehicle as soon as week 1, the first post-baseline assessment, and there were no safety concerns. Reproxalap may represent an innovative, rapidly acting therapeutic option for patients with DED. Trial Registration Clinicaltrials.gov NCT03916042 and NCT03879863.

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Cite

BibTeXRIS
BibTeX
@article{sheppard2026effect,
  title = {{Effect of Reproxalap Treatment on Dry Eye Disease Symptoms: Analysis of Pooled Data From Two Randomized, Vehicle-Controlled, 12-Week Clinical Trials}},
  author = {John D. Sheppard and Kelly Nichols and Christopher E. Starr and Amber Lewis and Desiree Owen and Cathy Zhao and Mei Li and Bill Cavanagh and Todd C. Brady},
  journal = {Ophthalmology and Therapy},
  year = {2026},
  month = sep,
  doi = {10.1007/s40123-026-01503-0},
  url = {https://doi.org/10.1007/s40123-026-01503-0},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - Effect of Reproxalap Treatment on Dry Eye Disease Symptoms: Analysis of Pooled Data From Two Randomized, Vehicle-Controlled, 12-Week Clinical Trials
AU  - John D. Sheppard
AU  - Kelly Nichols
AU  - Christopher E. Starr
AU  - Amber Lewis
AU  - Desiree Owen
AU  - Cathy Zhao
AU  - Mei Li
AU  - Bill Cavanagh
AU  - Todd C. Brady
PY  - 2026
DA  - 2026/09/01
JO  - Ophthalmology and Therapy
DO  - 10.1007/s40123-026-01503-0
UR  - https://doi.org/10.1007/s40123-026-01503-0
AB  - Introduction Reproxalap is a novel reactive aldehyde species inhibitor. Pooled data from two clinical trials were used to evaluate effects on symptoms and safety of reproxalap treatment versus vehicle in participants with dry eye disease (DED). Methods Data were pooled from identically designed arms of two 12-week, randomized, vehicle-controlled, double-masked, parallel-group clinical trials comparing topical ophthalmic reproxalap 0.25% with vehicle, each dosed four times daily for 4 weeks then twice daily for 8 weeks, in participants with DED. Symptoms of ocular dryness and ocular discomfort were assessed using a visual analog scale (0–100) in the intent-to-treat ocular dryness (ITTOD) population (prespecified for the symptom primary endpoint analysis in each trial) of participants with a baseline ocular dryness score of ≥ 3 on the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire. Safety parameters were evaluated in all treated participants. Results A total of 417 participants received study treatment (207 reproxalap, 210 vehicle), and 335 participants were included in the ITTOD population (167 reproxalap, 168 vehicle). The mean improvement from baseline in both ocular dryness and ocular discomfort scores was greater with reproxalap than vehicle at each timepoint (nominal p < 0.05). The least-squares mean difference (reproxalap − vehicle) in overall change from baseline from week 1 to week 12 was −8.5 (95% CI −12.6 to −4.5, p < 0.001) for ocular dryness score and −7.7 (95% CI −11.8 to −3.5, p < 0.001) for ocular discomfort score. The most common adverse event was mild instillation site irritation. There were no serious treatment-related adverse events. Conclusions Reproxalap reduced ocular dryness and discomfort symptoms compared with vehicle as soon as week 1, the first post-baseline assessment, and there were no safety concerns. Reproxalap may represent an innovative, rapidly acting therapeutic option for patients with DED. Trial Registration Clinicaltrials.gov NCT03916042 and NCT03879863.
SN  - 2193-8245
SN  - 2193-6528
ER  -