To assess the activity of reproxalap, a novel reactive aldehyde species (RASP) inhibitor, relative to vehicle in patients with dry eye disease (DED) DESIGN: Randomized, double-masked, vehicle-controlled Phase 2b trial METHODS: Three hundred DED were randomly assigned 1:1:1 at multiple US sites receive 0.1% topical ocular 0.25% or vehicle. Eyes treated bilaterally 4 times daily for 12 weeks. Standard signs and symptoms assessed baseline Weeks 2, 4, 8, 12.A dose response was observed DED....

Inflammatory cytokines have been shown to upregulate secretion of the antioxidant enzyme extracellular superoxide dismutase (EC-SOD) in dermal fibroblasts and, other cells, stimulate production nitric oxide (⋅ NO). Because rapidly scavenges ⋅ NO, forming injurious peroxynitrite anion (OONO − ), we hypothesize that stimulated cells EC-SOD expression concurrently with NO release. To test for coregulation and within same cell, timing inducible synthase (iNOS) transcription was measured after...

Purpose: To determine whether reproxalap, a novel reactive aldehyde species (RASP) inhibitor, is safe and effective for the treatment of signs symptoms dry eye disease (DED). Methods: In randomized double-masked parallel-group Phase 2a trial 3 topical ocular reproxalap formulations (0.1% ophthalmic solution, 0.5% lipid solution), 51 patients with DED were randomly assigned 1:1:1 at single US site. Eyes treated bilaterally 4 times daily 28 days, standard assessed baseline after 7 days dosing....

To assess the prophylactic and treatment activity of reproxalap, a novel reactive aldehyde species inhibitor, in real-world model allergen exposure.In randomized, double-masked, vehicle-controlled, crossover Phase 2 trial, 70 adult patients with ≥2 years moderate to severe allergic conjunctivitis history, positive skin test ragweed pollen, chamber-induced ocular itching redness scores ≥2.5 (both scales range from 0 4), respectively, were randomized 1:1:1 one three sequences: 0.25% 0.5%...

Interest in the toxicological aspects of oxidative stress has grown recent years, and research become increasingly focused on mechanistic damage cellular responses biological systems. Toxic consequences at subcellular level include lipid peroxidation to DNA proteins. These effects are often used as end points study stress. Typically, mammalian species have been models elucidate mechanisms underlying response, largely because interest human health issues surrounding However, it is becoming...

Purpose: Topical corticosteroids used to treat ocular inflammation are associated with a high risk of clinically significant toxicities. Therefore, corticosteroid-sparing medications needed. Noninfectious anterior uveitis (NAU) is sight-threatening inflammatory condition typically treated topical corticosteroids. This corticosteroid-controlled comparator trial examines the safety and efficacy reproxalap, novel inhibitor reactive aldehyde species (RASP), for treatment inflammation, by using...

This clinical trial assessed the activity of reproxalap, a novel reactive aldehyde species modulator, and estimated clinically relevant thresholds for changes in ocular itching redness an allergic conjunctivitis field trial.This was randomized, double-masked, vehicle-controlled phase 2 trial. Patients with ragweed-associated were over 28 days environmental setting approximately four doses per day either 0.25% 0.5% or vehicle. recorded itching, redness, tearing, eyelid swelling scores (each...

There is an unmet need for new treatments allergic conjunctivitis.To assess the activity of reproxalap, a novel reactive aldehyde species modulator, in real-world model seasonal allergen exposure.The INVIGORATE Trial, prospective, quadruple-masked, vehicle-controlled, crossover, sequence-randomized Phase 3 trial, tested efficacy reproxalap adults with history moderate to severe conjunctivitis, ragweed pollen allergy, and chamber-induced ocular itching redness. Patients were randomly assigned...

To assess the subjective eye drop experience of patients with dry disease (DED) over approximately 1 hour after a single dose two formulations reproxalap versus lifitegrast.Two topical ocular 0.25% were evaluated lifitegrast ophthalmic solution 5% in DED single-center, double-masked, active-comparator, single-dose crossover clinical trial. Nineteen had test article topically administered to both eyes. Treatments 2 4 days apart. Comfort assessments, including discomfort, blurry vision, and...

The initial pulmonary vasodilation that occurs during nitric oxide (⋅ NO) inhalation does not appear to be maintained chronically in many cases. ⋅ NO may acutely relax vascular smooth muscle by increasing levels of guanosine 3′,5′-cyclic monophosphate (cGMP), tumor necrosis factor (TNF)-α, and inducible synthase (iNOS) while decreasing lipid peroxidation. It was hypothesized the acute NO-induced changes cGMP, TNF-α, iNOS, peroxidation, all which mediate vasodilation, are transient rather...