Ophthalmology and therapy · 2026
Phase 3 Randomized Clinical Trial Evaluating the Safety of Reproxalap in Patients With Dry Eye Disease.
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Radcliffe Nathan M, Sheppard John, Simmons Blake, Owen Desiree, Nguyen Ashley, Cavanagh Bill, Brady Todd C
Аннотация
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.
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.