The Experts below are selected from a list of 12 Experts worldwide ranked by ideXlab platform

Todd C Brady - One of the best experts on this subject based on the ideXlab platform.

  • Early Onset and Broad Activity of Reproxalap in a Randomized, Double-Masked, Vehicle-Controlled Phase 2b Trial in Dry Eye Disease.
    American journal of ophthalmology, 2021
    Co-Authors: David Clark, Joseph Tauber, John Sheppard, Todd C Brady
    Abstract:

    To assess the activity of Reproxalap, a novel reactive aldehyde species (RASP) inhibitor, relative to vehicle in patients with dry eye disease (DED). Randomized, double-masked, vehicle-controlled Phase 2b trial. Three hundred patients with DED were randomly assigned 1:1:1 at multiple US sites to receive 0.1% topical ocular Reproxalap, 0.25% topical ocular Reproxalap, or vehicle. Eyes were treated bilaterally 4 times daily for 12 weeks. Standard signs and symptoms of DED were assessed at baseline and at Weeks 2, 4, 8, and 12. A dose response was observed for signs and symptoms of DED. Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25% P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25% P = .030). A greater proportion of patients receiving 0.25% Reproxalap versus vehicle reported dryness scores of 0 (P = .012). Improvements in combined DED symptoms were evident by the first postbaseline visit (week 2, 0.25% P < .0001) in patients with baseline scores ≥ median values. No significant changes in safety measures were observed. The novel RASP inhibitor Reproxalap demonstrated rapid, broad, and clinically relevant symptomatic control, in conjunction with statistically significant improvement over vehicle in signs of DED as demonstrated by fluorescein staining, in DED patients over 12 weeks of therapy. The results represent the first vehicle-controlled evidence for the therapeutic potential of RASP inhibition to mitigate the signs and symptoms of dry eye disease. Copyright © 2021. Published by Elsevier Inc.

  • A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease.
    Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics, 2021
    Co-Authors: David Clark, John Sheppard, Todd C Brady
    Abstract:

    Purpose: To determine whether Reproxalap, a novel reactive aldehyde species (RASP) inhibitor, is safe and effective for the treatment of the signs and symptoms of dry eye disease (DED). Methods: In a randomized double-masked parallel-group Phase 2a trial of 3 topical ocular Reproxalap formulations (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid ophthalmic solution), 51 patients with DED were randomly assigned 1:1:1 at a single US site. Eyes were treated bilaterally 4 times daily for 28 days, and standard DED signs and symptoms were assessed at baseline and after 7 and 28 days of dosing. Tear RASP levels were assessed at baseline and at day 28. Results: The effect of treatment on DED signs and symptoms was similar across the treatment arms, and pooled data from the 28-day treatment period demonstrated significant improvement from baseline in Symptom Assessment in Dry Eye Disease score (P = 0.003), Ocular Discomfort Scale score (P 

David Clark - One of the best experts on this subject based on the ideXlab platform.

  • Early Onset and Broad Activity of Reproxalap in a Randomized, Double-Masked, Vehicle-Controlled Phase 2b Trial in Dry Eye Disease.
    American journal of ophthalmology, 2021
    Co-Authors: David Clark, Joseph Tauber, John Sheppard, Todd C Brady
    Abstract:

    To assess the activity of Reproxalap, a novel reactive aldehyde species (RASP) inhibitor, relative to vehicle in patients with dry eye disease (DED). Randomized, double-masked, vehicle-controlled Phase 2b trial. Three hundred patients with DED were randomly assigned 1:1:1 at multiple US sites to receive 0.1% topical ocular Reproxalap, 0.25% topical ocular Reproxalap, or vehicle. Eyes were treated bilaterally 4 times daily for 12 weeks. Standard signs and symptoms of DED were assessed at baseline and at Weeks 2, 4, 8, and 12. A dose response was observed for signs and symptoms of DED. Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25% P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25% P = .030). A greater proportion of patients receiving 0.25% Reproxalap versus vehicle reported dryness scores of 0 (P = .012). Improvements in combined DED symptoms were evident by the first postbaseline visit (week 2, 0.25% P < .0001) in patients with baseline scores ≥ median values. No significant changes in safety measures were observed. The novel RASP inhibitor Reproxalap demonstrated rapid, broad, and clinically relevant symptomatic control, in conjunction with statistically significant improvement over vehicle in signs of DED as demonstrated by fluorescein staining, in DED patients over 12 weeks of therapy. The results represent the first vehicle-controlled evidence for the therapeutic potential of RASP inhibition to mitigate the signs and symptoms of dry eye disease. Copyright © 2021. Published by Elsevier Inc.

  • a randomized double masked phase 2a trial to evaluate activity and safety of topical ocular Reproxalap a novel rasp inhibitor in dry eye disease
    Journal of Ocular Pharmacology and Therapeutics, 2021
    Co-Authors: David Clark, John D Sheppard, Todd Brady
    Abstract:

    Purpose: To determine whether Reproxalap, a novel reactive aldehyde species (RASP) inhibitor, is safe and effective for the treatment of the signs and symptoms of dry eye disease (DED). Methods: In...

  • A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease.
    Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics, 2021
    Co-Authors: David Clark, John Sheppard, Todd C Brady
    Abstract:

    Purpose: To determine whether Reproxalap, a novel reactive aldehyde species (RASP) inhibitor, is safe and effective for the treatment of the signs and symptoms of dry eye disease (DED). Methods: In a randomized double-masked parallel-group Phase 2a trial of 3 topical ocular Reproxalap formulations (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid ophthalmic solution), 51 patients with DED were randomly assigned 1:1:1 at a single US site. Eyes were treated bilaterally 4 times daily for 28 days, and standard DED signs and symptoms were assessed at baseline and after 7 and 28 days of dosing. Tear RASP levels were assessed at baseline and at day 28. Results: The effect of treatment on DED signs and symptoms was similar across the treatment arms, and pooled data from the 28-day treatment period demonstrated significant improvement from baseline in Symptom Assessment in Dry Eye Disease score (P = 0.003), Ocular Discomfort Scale score (P 

John Sheppard - One of the best experts on this subject based on the ideXlab platform.

  • Early Onset and Broad Activity of Reproxalap in a Randomized, Double-Masked, Vehicle-Controlled Phase 2b Trial in Dry Eye Disease.
    American journal of ophthalmology, 2021
    Co-Authors: David Clark, Joseph Tauber, John Sheppard, Todd C Brady
    Abstract:

    To assess the activity of Reproxalap, a novel reactive aldehyde species (RASP) inhibitor, relative to vehicle in patients with dry eye disease (DED). Randomized, double-masked, vehicle-controlled Phase 2b trial. Three hundred patients with DED were randomly assigned 1:1:1 at multiple US sites to receive 0.1% topical ocular Reproxalap, 0.25% topical ocular Reproxalap, or vehicle. Eyes were treated bilaterally 4 times daily for 12 weeks. Standard signs and symptoms of DED were assessed at baseline and at Weeks 2, 4, 8, and 12. A dose response was observed for signs and symptoms of DED. Relative to vehicle over 12 weeks of therapy, the largest symptomatic improvement was observed in ocular dryness (0.25% P = .047), and the largest objective sign improvement was observed in nasal region fluorescein staining (0.25% P = .030). A greater proportion of patients receiving 0.25% Reproxalap versus vehicle reported dryness scores of 0 (P = .012). Improvements in combined DED symptoms were evident by the first postbaseline visit (week 2, 0.25% P < .0001) in patients with baseline scores ≥ median values. No significant changes in safety measures were observed. The novel RASP inhibitor Reproxalap demonstrated rapid, broad, and clinically relevant symptomatic control, in conjunction with statistically significant improvement over vehicle in signs of DED as demonstrated by fluorescein staining, in DED patients over 12 weeks of therapy. The results represent the first vehicle-controlled evidence for the therapeutic potential of RASP inhibition to mitigate the signs and symptoms of dry eye disease. Copyright © 2021. Published by Elsevier Inc.

  • A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease.
    Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics, 2021
    Co-Authors: David Clark, John Sheppard, Todd C Brady
    Abstract:

    Purpose: To determine whether Reproxalap, a novel reactive aldehyde species (RASP) inhibitor, is safe and effective for the treatment of the signs and symptoms of dry eye disease (DED). Methods: In a randomized double-masked parallel-group Phase 2a trial of 3 topical ocular Reproxalap formulations (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid ophthalmic solution), 51 patients with DED were randomly assigned 1:1:1 at a single US site. Eyes were treated bilaterally 4 times daily for 28 days, and standard DED signs and symptoms were assessed at baseline and after 7 and 28 days of dosing. Tear RASP levels were assessed at baseline and at day 28. Results: The effect of treatment on DED signs and symptoms was similar across the treatment arms, and pooled data from the 28-day treatment period demonstrated significant improvement from baseline in Symptom Assessment in Dry Eye Disease score (P = 0.003), Ocular Discomfort Scale score (P 

Todd Brady - One of the best experts on this subject based on the ideXlab platform.

John D Sheppard - One of the best experts on this subject based on the ideXlab platform.