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Introduction <p>Reactive aldehyde species (RASP) are proinflammatory molecules that have been implicated in ocular inflammatory diseases, including dry eye disease (DED). Reproxalap is a small&#xa0;molecule RASP inhibitor in development for the treatment of DED. The objective of this clinical trial was to evaluate the long-term safety of reproxalap 0.25% ophthalmic solution compared with vehicle in patients with DED.</p> Methods <p>This was a phase 3, multicenter, double-masked, randomized, vehicle-controlled, parallel-group safety clinical trial in patients with DED. Eligible patients were randomized 2:1 to bilateral treatment with reproxalap or vehicle for 6&#xa0;weeks or 12&#xa0;months, with the treatment administered four times daily (QID) for the first 4&#xa0;weeks then twice daily (BID) for either 2&#xa0;weeks or 11&#xa0;months. Safety assessments included treatment-emergent adverse events (TEAEs), slit-lamp biomicroscopy, dilated fundoscopy, best-corrected visual acuity (BCVA), intraocular pressure, corneal endothelial cell density, and laboratory assessments. The primary endpoint was the occurrence of treatment-related serious ocular TEAEs.</p> Results <p>A total of 757 patients were enrolled and treated with reproxalap (<i>n</i> = 504) or vehicle (<i>n</i> = 253). In the 12-month arms, 111 and 72 patients receiving reproxalap and vehicle, respectively, completed the trial. There were no treatment-related serious TEAEs. The most common TEAE in reproxalap-treated patients was transient, mild, instillation site irritation, most commonly lasting &lt; 1&#xa0;min. Other ocular TEAEs were similar between reproxalap and vehicle. No safety concerns were identified. Post&#xa0;hoc analysis of BCVA change from baseline in the 12-month safety population showed larger BCVA improvement over 12&#xa0;months with reproxalap compared with vehicle (<i>p</i> = 0.0185).</p> Conclusions <p>The results support the safety of long-term topical reproxalap therapy in patients with DED.</p> Trial Registration <p>ClinicalTrials.gov identifier NCT04735393.</p>

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Phase 3 Randomized Clinical Trial Evaluating the Safety of Reproxalap in Patients With Dry Eye Disease

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月11日

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  • Nathan M. Radcliffe,
  • John Sheppard,
  • Blake Simmons,
  • Desiree Owen,
  • Ashley Nguyen,
  • Bill Cavanagh,
  • Todd C. Brady

摘要

Introduction

Reactive aldehyde species (RASP) are proinflammatory molecules that have been implicated in ocular inflammatory diseases, including dry eye disease (DED). Reproxalap is a small molecule RASP inhibitor in development for the treatment of DED. The objective of this clinical trial was to evaluate the long-term safety of reproxalap 0.25% ophthalmic solution compared with vehicle in patients with DED.

Methods

This was a phase 3, multicenter, double-masked, randomized, vehicle-controlled, parallel-group safety clinical trial in patients with DED. Eligible patients were randomized 2:1 to bilateral treatment with reproxalap or vehicle for 6 weeks or 12 months, with the treatment administered four times daily (QID) for the first 4 weeks then twice daily (BID) for either 2 weeks or 11 months. Safety assessments included treatment-emergent adverse events (TEAEs), slit-lamp biomicroscopy, dilated fundoscopy, best-corrected visual acuity (BCVA), intraocular pressure, corneal endothelial cell density, and laboratory assessments. The primary endpoint was the occurrence of treatment-related serious ocular TEAEs.

Results

A total of 757 patients were enrolled and treated with reproxalap (n = 504) or vehicle (n = 253). In the 12-month arms, 111 and 72 patients receiving reproxalap and vehicle, respectively, completed the trial. There were no treatment-related serious TEAEs. The most common TEAE in reproxalap-treated patients was transient, mild, instillation site irritation, most commonly lasting < 1 min. Other ocular TEAEs were similar between reproxalap and vehicle. No safety concerns were identified. Post hoc analysis of BCVA change from baseline in the 12-month safety population showed larger BCVA improvement over 12 months with reproxalap compared with vehicle (p = 0.0185).

Conclusions

The results support the safety of long-term topical reproxalap therapy in patients with DED.

Trial Registration

ClinicalTrials.gov identifier NCT04735393.