Aldeyra Therapeutics Announces Positive Results from Dry Eye Disease Phase 2a Clinical Trial
"ADX-102 is a promising agent for the treatment of dry eye disease, a persistently challenging condition for many people worldwide," commented
The randomized, dose-ranging, parallel-group, double-masked Phase 2a clinical trial investigated three formulations of ADX-102 (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid formulation) in 51 dry eye disease patients (17 per arm) treated for 28 days. The results from the pooled data over the 28-day treatment period demonstrated statistically significant improvement from baseline in Symptom Assessment in Dry Eye (SANDE) Score (p=0.003), Ocular Discomfort Score (p=0.00002), Overall Four-Symptom Score (p=0.0004), Schirmer (tear volume) Test (p=0.008), tear osmolarity (p=0.003), and Lissamine Green ocular surface staining score (p=0.002). Improvements in dry eye disease signs and symptoms were evident within one week of therapy. A modest dose-response was observed, and activity increased over the duration of therapy, supporting evidence of the effect of drug. Levels of malondialdehyde, a pro-inflammatory aldehyde mediator sequestered by ADX-102, were significantly reduced in the tears of patients (p=0.009), supporting the differentiated mechanism of action relative to other therapies in dry eye disease.
The primary objective of the trial was to select a formulation and dose range for a Phase 2b clinical trial. Based on consistent statistically and clinically significant activity across multiple sign and symptom endpoints, and tolerability consistent with that of standard of care, 0.1% ADX-102 was nominated for advancement. Relative to baseline, improvement after 28 days of 0.1% ADX-102 therapy was statistically significant or approached statistical significance for Ocular Discomfort Score (p=0.002), the dryness component of the Four-Symptom Score (p=0.01), Overall Four-Symptom Score (p=0.048), SANDE Score (p=0.09),
There were no safety concerns observed for any of the formulations of ADX-102, and no serious adverse events were reported.
"These data represent the fourth set of positive Phase 2 results with ADX-102 in ocular inflammation. The breadth of activity across noninfectious anterior uveitis, allergic conjunctivitis, and now dry eye disease confirms the potential of ADX-102 as an important and differentiated therapy in ophthalmology," commented
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About Aldeyra Therapeutics
About Dry Eye Disease
Dry eye disease is a common inflammatory disease estimated to affect approximately 20 million people in
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's plans and expectations for the development of ADX-102 and the timing thereof; the potential of ADX-102 as an agent for the treatment of dry eye disease; the ability of ADX-102 to provide important patient benefits and a differentiated mechanism of action relative to existing therapies; and estimates of the market size for Dry Eye Disease. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will,"
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updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities, the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize Aldeyra's product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; the size and growth of the potential markets for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency of Aldeyra's cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding
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Commission(SEC) and available on the SEC's website at www.sec.gov. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials.
In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
Corporate Contact:
Tel: +1 781-761-4904 ext. 205
stulipano@aldeyra.com
Investor Contact:
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
781-591-3443
cduong@macbiocom.com
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