New statistical analyses of the results of a randomized, multi-center, investigator-masked, comparator-controlled, parallel-group Phase 2 clinical trial of topical ocular reproxalap (formerly known as ADX-102), a first-in-class aldehyde sequestering agent was presented to the American Uveitis Society held at the American Academy of Ophthalmology 2017 Annual Meeting. The results of the analyses demonstrated formal statistical non-inferiority (p=0.036 after two weeks of therapy, p=0.048 after four weeks of therapy) of 0.5% reproxalap ophthalmic solution to Pred Forte®, a topical ocular corticosteroid, in reducing anterior chamber inflammatory cell count, the standard noninfectious anterior uveitis clinical endpoint. The combination of reproxalap and low-frequency (twice-daily) Pred Forte® administration was also statistically non-inferior to Pred Forte® monotherapy (four-times-daily). Dr. John Sheppard, an internationally recognized expert in ocular inflammation, gave the presentation, which is available on the investor relations page of the Aldeyra Therapeutics corporate website at ir.aldeyra.com.
“The use of corticosteroid therapy for the treatment of ocular inflammation is hampered by ophthalmic toxicity, including cataract formation, secondary infection, viral reactivation, delayed wound healing and elevated intraocular pressure that can cause irreversible glaucomatous optic atrophy,” commented Dr. Sheppard. “Reproxalap could represent a welcome addition to the topical therapeutic options available to practitioners who treat noninfectious anterior uveitis, a severe inflammatory disease which can lead to permanent vision loss.”
In April 2017, Aldeyra announced the initiation of Phase 3 clinical trial of topical reproxalap in patients with noninfectious anterior uveitis. The Phase 3 trial is expected to enroll up to 100 patients with active disease, randomized equally to receive either 0.5% topical ocular reproxalap or vehicle for four weeks. Consistent with prior clinical trials used for marketing registration, the primary endpoint will be the resolution of anterior chamber cellular inflammation. Results of the trial are expected to be announced in the second half of 2018.
Pro-inflammatory aldehyde mediators are a novel target in the treatment of inflammation. The positive clinical results reported for reproxalap from Phase 2 clinical trials in dry eye disease, allergic conjunctivitis, and noninfectious anterior uveitis suggest that aldehyde sequestration could also be effective for the treatment of inflammatory diseases that affect other parts of the body, including systemic inflammatory and autoimmune conditions that afflict millions of patients worldwide.