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Aldeyra Surges on Positive Dry Eye Study Data on Reproxalap

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Aldeyra Therapeutics, Inc. (ALDX - Free Report) announced impressive results from a phase IIb study evaluating its topical ocular reproxalap as a treatment for dry eye disease. Early onset of improvement in patients and a broad range of activity achieved support the potential of the candidate as a promising therapeutic agent with a differentiated profile.

Shares of the company surged 34.9% on Sep 26, following the announcement. Aldeyra’s shares have rallied 96.3% so far this year compared with the industry’s growth of 2.6%.



The phase IIb study evaluated two doses – 0.1% and 0.25% concentration – of reproxalap topical ophthalmic solution compared to a vehicle. Data from the study showed that 0.25% concentration of the candidate achieved statistically significant reduction in both Four-Symptom Ocular Dryness Score and Overall Ocular Discomfort Symptom Score compared to the vehicle.

Moreover, symptomatic improvements in patients treated with reproxalap were observed two weeks earlier than the vehicle. This data was consistent with the previously completed phase IIa study. The data also supported a differentiated product profile for the candidate compared to the current standard of care.

Following the successful completion of the phase IIb study, Aldeyra is planning to initiate a pivotal phase III study on reproxalap in 2019.

Shire’s (SHPG - Free Report) Xiidra and Allergan’s (AGN - Free Report) Restasis are among the approved drugs for the treatment of dry eye disease. Sales of Restasis in the first half of 2018 were $608 million while sales at Shire’s Opthalmics franchise surged 75% in the second quarter to $100 million on strong Xiidra demand growth.

Although availability of other drugs in the market is competitive, sales and growth of other drugs suggest significant prospect for reproxalap, once approved, on the back of its differentiated and better therapeutic profile.

The company is also evaluating reproxalap in other late-stage studies as a treatment for allergic conjunctivitis and noninfectious anterior uveitis.

Zacks Rank & Stock to Consider

Aldyera is a Zacks Rank #3 (Hold) stock currently.

A better-ranked stock from the same space is BioSpecifics Technologies Corp (BSTC - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

BioSpecifics’ earnings per share estimates have increased from $2.09 to $2.28 for 2018 and from $2.13 to $2.38 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 11.37%. The stock has rallied 31.5% year to date.

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