Aldeyra Therapeutics (Nasdaq: ALDX) reported Q1 EPS of ($0.51), $0.01 worse than the analyst estimate of ($0.50).

Aldeyra also reported that a randomized, multi-center, investigator-masked, comparator-controlled, parallel-group Phase II clinical trial of topical ocular NS2, a first-in-class aldehyde trap, demonstrated activity comparable to standard-of-care topical ocular corticosteroids in reducing anterior chamber cell count in patients with active noninfectious anterior uveitis.

Topical corticosteroids are often associated with ocular toxicity, including cataract formation and glaucoma (elevated intra-ocular pressure). The data released today suggest that NS2 has the potential to reduce or replace corticosteroid use in noninfectious anterior uveitis.

Commenting on the results, Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, said, "We are excited about these results, which, in combination with the positive data in allergic conjunctivitis that were released earlier this year, broaden the potential therapeutic applicability of topical ocular NS2 to many ocular inflammatory diseases. We look forward to continuing to develop aldehyde traps as a novel approach for the treatment of inflammation."

Forty-five subjects were randomized equally to receive NS2 0.5% four times daily, Pred Forte 1% (a corticosteroid) four times daily (tapered), or NS2 0.5% four times daily and Pred Forte 1% twice daily (tapered). There were no statistical differences among all groups in any clinical endpoint, including anterior chamber cell count and ocular flare. NS2 was generally well tolerated and there were no serious adverse events, consistent with previous Phase I and Phase II clinical trials.

NS2 produced clinically meaningful effects on anterior chamber cell counts (ACC) comparable to corticosteroid. At the week 2 study visit, grade 0 (cell count of zero or one) ACC treatment response was seen in 33% of NS2 patients, 31% of Pred Forte patients, and 31% of patients on combination therapy. At the week 8 study visit, grade 0 ACC treatment response was seen in 40% of NS2 patients, 46% of Pred Forte patients, and 44% of patients on combination therapy. For ACC improvement of at least one grade, treatment response was seen in 53% of NS2 patients, 46% of Pred Forte patients, and 50% of patients on combination therapy. For subjects that did not respond to therapy, rescue medication rates were similar between NS2 and Pred Forte, with rescue medication required in 20% of NS2 patients, 38% of Pred Forte patients and 25% of patients on combination therapy.

The principal investigator of the trial, Dr. Stephen Foster, a leading expert in ocular inflammation, has described this study outcome as "very encouraging with NS2 demonstrating clear activity in anterior uveitis and no evidence of significant adverse effects. This suggests that NS2 may be an important future treatment option for anterior uveitis patients. Effectiveness equal to topical corticosteroids with the absence of eye pressure elevation or cataract production would make this anti-inflammatory therapy an attractive therapeutic option for treating uveitis."

Aldehydes are thought to mediate both major forms of inflammation, allergy (such as allergic conjunctivitis) and autoimmune disease (such as noninfectious anterior uveitis). In February 2016, Aldeyra reported positive Phase II data with topical ocular NS2 in allergic conjunctivitis. The Phase II results in noninfectious anterior uveitis released today suggest that NS2 is also active in autoimmune disease.

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