In addition, Aldeyra will present novel combined data analyses from the Phase 2b clinical trial and Part 1 of the Phase 3 RENEW Trial in dry eye disease. The analyses included approximately 460 patients treated with reproxalap for up to four weeks, during which site visits, formulation, and dosing regimen were the same across the trials. Statistically significant improvement over vehicle was demonstrated in the combined data for ocular dryness
(p = 0.008) and nasal region fluorescein staining (p = 0.003).
Topical ocular reproxalap has now been studied in over 1,100 patients with no observed safety concerns reported; mild instillation site irritation is the most commonly reported adverse event in clinical trials.
Aldeyra will also present the results of ahead-to-head tolerability clinical trial of the current formulation of investigational new drug reproxalap and the novel formulation of reproxalap versus Xiidra® (lifitegrast ophthalmic solution) over one hour after drop instillation. The tolerability of both formulations of reproxalap, as assessed by a variety of drop experience scores including ocular discomfort, blurry vision, and taste disturbance, was statistically superior to that of Xiidra®. In a crossover design with athree-day washout period between visits, nineteen patients were exposed at each visit to either Xiidra®, the current formulation of reproxalap, or the novel formulation of reproxalap. No statistical differences were noted in tolerability between the current formulation of reproxalap and the novel formulation of reproxalap. The trial compared only tolerability under the aforementioned conditions.
“Reproxalap has now metpre-specified andFDA-sanctioned symptom endpoints in the formulation trial and in Part 1 of the RENEW Trial,” said Todd Brady, M.D., Ph.D., President and CEO of Aldeyra. “The recent clinical results, in addition to the combined trial analyses andhead-to-head tolerability data released today, highlight a compelling development program for what we continue to believe could be the next novel entrant in the dry eye disease market.”
Topical ocular reproxalap is also being investigated in patients with allergic conjunctivitis in the Phase 3 INVIGORATE Trial. The INVIGORATE Trial, which will enroll approximately 120 patients, is a randomized, double-masked, crossover vehicle-controlled Phase 3 clinical trial to assess the efficacy and safety of 0.25% reproxalap topical ophthalmic solution compared to vehicle using an allergen chamber. Consistent with the company’s prior allergic conjunctivitis trials, the primary endpoint will be subject-reported ocular itching score.Top-line results from the INVIGORATE Trial are expected in the second half of 2020. In 2019, Aldeyra announced achievement of the primary endpoint of the Phase 3 ALLEVIATE Trial in allergic conjunctivitis, as well as statistically significant reductions in ocular itching and redness in an allergen chamber clinical trial.
Aldeyra will present an updated market assessment of allergic conjunctivitis, which affects more than 1 billion people worldwide,i including more than 100 million in the U.S.ii The signs and symptoms of allergic conjunctivitis – ocular itching, redness, and tearing – are persistently disturbing, affecting quality of life and leading to loss of work that can create a substantial economic burden for patients and families.iii The prevalence of allergic conjunctivitis is growing due to longer allergy seasons and the geographic spread of allergen-producing plants.
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