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Peer-reviewedCC BY-NC 4.0Therapeutic Advances in Ophthalmology

Reproxalap 0.25% in dry eye disease: A meta-analysis of randomized controlled trials

  • Muhammad Imaz Bhatti1
  • Mohsin Rashid1
  • Ishmal Fatima Shahid1
  • Saleha Azeem1
  • Shameer Iqbal Ghuman1
  • Muhammad Abdullah1
  • Eilaf Azeem2
  • Husam Abu Dawood3
  • Hashem Abu Serhan4
4 affiliations
  1. 1Department of Ophthalmology, King Edward Medical University, Lahore, Pakistan
  2. 2Department of Sciences, International School Lahore, Lahore, Pakistan
  3. 3Faculty of Medicine, Palestine Polytechnic University, Hebron, Palestine
  4. 4Department of Ophthalmology, Hamad Medical Corporation, Doha, Qatar
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Abstract

Background: Dry eye disease (DED) is a common, chronic inflammatory disorder of the ocular surface that can impair vision and reduce quality of life. Reproxalap, a novel reactive aldehyde species (RASP) modulator, has shown potential as a targeted anti-inflammatory therapy.

Objective: To evaluate the efficacy and safety of reproxalap 0.25% in patients with DED, with allergic conjunctivitis included as a secondary exploratory analysis.

Design: Systematic review and meta-analysis.

Data Sources and Methods: PubMed, Embase, and ClinicalTrials.gov were systematically searched to identify randomized controlled trials (RCTs) evaluating reproxalap. Meta-analyses were performed using RevMan 5.4 with a random-effects model.

Results: Twelve RCTs were included, comprising 8 studies in DED (n = 2,283) and 4 studies in allergic conjunctivitis (n = 418). In DED, reproxalap significantly reduced ocular dryness scores (SMD: −0.23, 95% CI: −0.38 to −0.08; I2 = 0%), increased Schirmer test mean change from baseline (MD: 2.32 mm, 95% CI: 1.55 to 3.10; I2 = 0%), improved Schirmer test responder rates (RR: 2.05, 95% CI: 1.71 to 2.44; I2 = 0%), and reduced conjunctival redness (MD: −0.13, 95% CI: −0.25 to −0.02; I2 = 36%). Exploratory analyses of allergic conjunctivitis showed favorable effect estimates for ocular itching, tearing, and conjunctival redness. However, heterogeneity was substantial across outcomes (I2 = 83–96%), the certainty of evidence was very low according to GRADE, and the findings were not robust in sensitivity analyses.

Conclusion: Reproxalap was associated with consistent improvements across key clinical outcomes in DED. Exploratory allergic conjunctivitis findings should be considered hypothesis-generating rather than clinically conclusive. Interpretation of the overall evidence is limited by exclusive industry sponsorship, evidence of publication bias, and the predominantly subjective nature of the primary endpoints. Further large-scale, independently funded RCTs in DED are warranted to further establish the efficacy and safety of reproxalap.

Registration: PROSPERO CRD420251070669.

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Cite

BibTeXRIS
BibTeX
@article{bhatti2026reproxalap,
  title = {{Reproxalap 0.25% in dry eye disease: A meta-analysis of randomized controlled trials}},
  author = {Muhammad Imaz Bhatti and Mohsin Rashid and Ishmal Fatima Shahid and Saleha Azeem and Shameer Iqbal Ghuman and Muhammad Abdullah and Eilaf Azeem and Husam Abu Dawood and Hashem Abu Serhan},
  journal = {Therapeutic Advances in Ophthalmology},
  year = {2026},
  month = sep,
  doi = {10.1177/25158414261491554},
  url = {https://doi.org/10.1177/25158414261491554},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Reproxalap 0.25% in dry eye disease: A meta-analysis of randomized controlled trials
AU  - Muhammad Imaz Bhatti
AU  - Mohsin Rashid
AU  - Ishmal Fatima Shahid
AU  - Saleha Azeem
AU  - Shameer Iqbal Ghuman
AU  - Muhammad Abdullah
AU  - Eilaf Azeem
AU  - Husam Abu Dawood
AU  - Hashem Abu Serhan
PY  - 2026
DA  - 2026/09/21
JO  - Therapeutic Advances in Ophthalmology
DO  - 10.1177/25158414261491554
UR  - https://doi.org/10.1177/25158414261491554
AB  - Background: Dry eye disease (DED) is a common, chronic inflammatory disorder of the ocular surface that can impair vision and reduce quality of life. Reproxalap, a novel reactive aldehyde species (RASP) modulator, has shown potential as a targeted anti-inflammatory therapy.  Objective: To evaluate the efficacy and safety of reproxalap 0.25% in patients with DED, with allergic conjunctivitis included as a secondary exploratory analysis.  Design: Systematic review and meta-analysis.  Data Sources and Methods: PubMed, Embase, and ClinicalTrials.gov were systematically searched to identify randomized controlled trials (RCTs) evaluating reproxalap. Meta-analyses were performed using RevMan 5.4 with a random-effects model.  Results: Twelve RCTs were included, comprising 8 studies in DED (n = 2,283) and 4 studies in allergic conjunctivitis (n = 418). In DED, reproxalap significantly reduced ocular dryness scores (SMD: −0.23, 95% CI: −0.38 to −0.08; I2 = 0%), increased Schirmer test mean change from baseline (MD: 2.32 mm, 95% CI: 1.55 to 3.10; I2 = 0%), improved Schirmer test responder rates (RR: 2.05, 95% CI: 1.71 to 2.44; I2 = 0%), and reduced conjunctival redness (MD: −0.13, 95% CI: −0.25 to −0.02; I2 = 36%). Exploratory analyses of allergic conjunctivitis showed favorable effect estimates for ocular itching, tearing, and conjunctival redness. However, heterogeneity was substantial across outcomes (I2 = 83–96%), the certainty of evidence was very low according to GRADE, and the findings were not robust in sensitivity analyses.  Conclusion: Reproxalap was associated with consistent improvements across key clinical outcomes in DED. Exploratory allergic conjunctivitis findings should be considered hypothesis-generating rather than clinically conclusive. Interpretation of the overall evidence is limited by exclusive industry sponsorship, evidence of publication bias, and the predominantly subjective nature of the primary endpoints. Further large-scale, independently funded RCTs in DED are warranted to further establish the efficacy and safety of reproxalap.  Registration: PROSPERO CRD420251070669.
SN  - 2515-8414
ER  -