Shares of Aldeyra Therapeutics, Inc. (ALDX - Free Report) surged by about 36% after the company announced positive top-line results from the phase III ALLEVIATE study, evaluating pipeline product, reproxalap topical ophthalmic solution in patients with allergic conjunctivitis.
The study met the primary endpoint and the key secondary endpoint for both concentrations (0.25% and 0.5%)of reproxalap. Aldeyra’s shares have rallied 16.3% in the past year, against the industry’s decline of 13.5%.
The study assessed the efficacy and safety of 0.25% and 0.5% concentrations of reproxalap topical ophthalmic solutions compared to vehicle in 318 patients (approximately 100 per arm) with seasonal allergic conjunctivitis. In the study, patients treated with 0.25% and 0.5% reproxalap demonstrated statistically significant reduction in ocular itching — the primary endpoint — compared to the patients treated with vehicle.
Two-point responder rates, a key secondary endpoint, for 0.25% and 0.5% reproxalap were statistically greater than that of vehicle-treated patients, confirming the clinical relevance of the observed primary endpoint improvements. The results of the only completed phase III study on the candidate are consistent with the positive results from five prior phase II studies in ocular inflammation.
Aldeyra plans to meet with regulatory authorities in the second half of 2019 to discuss the ALLEVIATE results and potential submission of the marketing application for the candidate.
Bausch Health Companies Inc. (BHC - Free Report) also submitted an application for an eye drop, EM-100, which is under review with the FDA. Upon approval, the eye drop will be the first over-the-counter (OTC) preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis. Bausch acquired the U.S. rights to EM-100 from Eton Pharmaceuticals in February 2019.
Zacks Rank & Stocks to Consider
Aldyera is a Zacks Rank #3 (Hold) stock currently.
Some better-ranked stocks worth considering are AstraZeneca Plc. (AZN - Free Report) and Roche Holding AG (RHHBY - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AstraZeneca’s earnings per share estimates have increased from $1.74 to $1.79 for 2019 and from $2.14 to $2.20 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 106.40%.
Roche’s earnings per share estimates have increased from $2.31 to $2.35 for 2019 and from $2.34 to $2.37 for 2020 over the past 90 days.
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