Aldeyra Therapeutics on Monday hosted the 2020 Research & Development Day (R&D Day) with investors and financial analysts in New York City to present recent clinical development updates and market opportunities for its novel investigational new drug product candidates in dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy. The event included presentations from members of the Aldeyra executive team and Paul Karpecki, OD, FAAO. Dr. Karpecki is Clinical Director, Corneal Services and Advanced Ocular Surface Disease at Kentucky Eye Institute and a clinician for Gaddie Eye Centers.
Aldeyra announced that the phase 2 novel formulation clinical trial in dry eye disease achieved the primary endpoint of symptom control. The double-masked, randomized, vehicle-controlled, multicenter, parallel-group clinical trial assessed the efficacy and safety of a novel formulation of 0.25% reproxalap topical ophthalmic solution compared to vehicle in 206 patients with moderate to severe dry eye disease. Relative to the formulation of 0.25% reproxalap topical ophthalmic solution used in prior clinical trials, the concentration of a single excipient was increased in the novel formulation. The primary efficacy endpoint was change from baseline versus vehicle in patient-reported ocular dryness score over 2 to 12 weeks of treatment. Relative to patients treated with vehicle, patients treated with reproxalap demonstrated statistically significant reduction in ocular dryness (P=0.03). Based on the results across the clinical studies conducted in dry eye disease to date, Aldeyra plans to meet with the FDA prior to initiating Part 2 of the RENEW Trial and expects to provide an update on future development plans in dry eye disease following FDA feedback.
In addition, Aldeyra presented 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 4 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 a head-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 1 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 a 3-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 met pre-specified and FDA-sanctioned symptom endpoints in the formulation trial and in Part 1 of the RENEW Trial,” Todd Brady, MD, PhD, President and CEO of Aldeyra, said in the news release. “The recent clinical results, in addition to the combined trial analyses and head-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. Topline 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, including more than 100 million in the U.S.