Aldeyra Therapeutics Inc. (NASDAQ: ALDX) stock gained by 1.28% at the last close whereas the ALDX stock price plunge by 36.33% in the after-hours trading session. Aldeyra Therapeutics is a biotechnology business dedicated to the development of innovative immune-modulating treatments for the treatment of ocular and systemic disorders.
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ALDX stock’ Current Update
Aldeyra Therapeutics released important findings from the 0.25 percent reproxalap ophthalmic solution Phase 3 TRANQUILITY Trial. It’s a potential treatment for an experimental medication to control dry eye conditions.
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Although the primary aim of ocular redness was not fulfilled in TRANQUILITY, the dry eye disease symptom of the Schirmer test, a secondary endpoint, attained statistical power (p=0.0001). The post-hoc analysis of Schirmer test responders of less than 10 mm also yielded statistical significance (p0.0001). The Schirmer test has been acknowledged as part of the foundation for approval of additional dry eye disease medicines by the US Food and Drug Administration. The primary endpoint of the planned Phase 3 TRANQUILITY-2 Trial has been changed so that it will be fulfilled if the Schirmer test or ocular redness show statistical significance. TRANQUILITY-2’s goal enrolment has now been expanded from 300 to up to 400 patients.
The dry eye disease NDA filing is scheduled in mid-2022, given the enrolment in the current 12-month safety study in dry eye disease individuals and the result of TRANQUILITY-2. Upon the dry eye disease submission and the fulfillment of an additional allergen chamber study required by the FDA, an NDA for allergic conjunctivitis is planned to be submitted. Phase 3 ALLEVIATE conjunctival allergen challenge study and Phase 3 INVIGORATE allergen chamber trial both met primary and major secondary objectives in allergic conjunctivitis.
In TRANQUILITY, no safety signals were seen, and reproxalap was well accepted; no hurdle related to treatment discontinuations or severe or major side events were reported. Over 1,500 patients have already been tested with Reproxalap. Mild and temporary instillation site soreness is the most commonly reported side event.