Aldeyra Therapeutics, Inc. ( ALDX Quick Quote ALDX - Free Report) announced positive data from the vehicle-controlled crossover clinical study which evaluated its investigational product candidate, 0.25% reproxalap ophthalmic solution, for the treatment of dry eye disease. The study met its primary endpoints.
Data from the study showed that reproxalap was statistically superior to the vehicle arm for both the primary endpoints — ocular redness in a dry eye chamber and Schirmer test, following a single day of dosing.
The study also achieved the secondary endpoint of Schirmer test ≥10 mm responder analysis, which was multiplicity-controlled.
Treatment with reproxalap was well tolerated and no safety signals were observed either.
Shares of Aldeyra gained 15% on Tuesday following the announcement of the news. The stock has rallied 28.6% so far this year against the
industry’s decline of 20.8%. Image Source: Zacks Investment Research
Aldeyra plans to submit the crossover study data as part of the new drug application (“NDA”) for reproxalap in dry eye disease, including data on ocular redness, Schirmer test and the Schirmer test ≥10 mm responder analysis.
The company has scheduled a pre-NDA meeting with the FDA later in the third quarter of 2022.
In June 2022, ALDX announced that the phase III TRANQUILITY-2 evaluating reproxalap for the treatment of dry eye disease had met its primary endpoint. Treatment with reproxalap demonstrated statistical superiority to vehicle for each of the two prespecified primary endpoints — Schirmer test and ≥10 mm Schirmer test responder proportions after a single day of dosing.
If successfully developed and upon potential approval, reproxalap may offer a potentially differentiated therapeutic option for the treatment of dry eye disease.
We note that several companies are developing their pipeline candidates for the treatment of dry eye disease.
Palatin Technologies ( PTN Quick Quote PTN - Free Report) is developing its melanocortin agonist, PL9643, in a phase III study for treating patients with dry eye disease.
PTN expects to report top-line data from the study in the second half of 2022.
Successful development of Palatin’s PL9643 is likely to induce competition for Aldeyra’s reproxalap.
Zacks Rank & Stocks to Consider
Aldeyra currently carries a Zacks Rank #3 (Hold). Top-ranked stocks in the same sector are
Spectrum Pharmaceuticals, Inc. ( SPPI Quick Quote SPPI - Free Report) and Galmed Pharmaceuticals Ltd. ( GLMD Quick Quote GLMD - Free Report) , both carrying a Zacks Rank #1 (Strong Buy) at present. You can see . the complete list of today’s Zacks #1 Rank stocks here
The Zacks Consensus Estimate for Spectrum Pharmaceuticals’ loss per share has narrowed 16.1% for 2022 and 36.3% for 2023 in the past 60 days.
Earnings of Spectrum Pharmaceuticals have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. SPPI delivered an earnings surprise of 5.72%, on average.
Galmed Pharmaceuticals’ loss per share estimates narrowed 37.9% for 2022 and 45% for 2023 in the past 60 days.
Earnings of Galmed Pharmaceuticals have surpassed estimates in each of the trailing three quarters. GLMD delivered an earnings surprise of 23.09%, on average.