July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
A Randomized, Double-Masked, Parallel-Group, Phase 2a Dry Eye Disease Clinical Trial to Evaluate the Safety and Efficacy of Topical Ocular ADX-102, a Novel Aldehyde Sequestering Agent
Author Affiliations & Notes
  • David Clark
    Clinical, Aldeyra Therapeutics, Lexington, Massachusetts, United States
  • George W Ousler
    Ora Inc., Andover, Massachusetts, United States
  • David Hollander
    Ora Inc., Andover, Massachusetts, United States
  • Todd Brady
    Clinical, Aldeyra Therapeutics, Lexington, Massachusetts, United States
  • Footnotes
    Commercial Relationships   David Clark, Aldeyra Therapeutics (E); George Ousler, Ora Inc. (E); David Hollander, Ora Inc. (E); Todd Brady, Aldeyra Therapeutics (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1967. doi:
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      David Clark, George W Ousler, David Hollander, Todd Brady; A Randomized, Double-Masked, Parallel-Group, Phase 2a Dry Eye Disease Clinical Trial to Evaluate the Safety and Efficacy of Topical Ocular ADX-102, a Novel Aldehyde Sequestering Agent. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1967.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : ADX-102 represents a new anti-inflammatory drug class in development for the treatment of dry eye disease (DED) as well as other forms of ocular inflammation. ADX-102 has demonstrated positive Phase 2 results in controlled trials in noninfectious anterior uveitis and allergic conjunctivitis. The study objective was to select a formulation and dose range for Phase 2b.

Methods : A randomized, double-masked, parallel-group trial of 3 ADX-102 formulations (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid formulation) conducted in 51 DED subjects at a single US site. Subjects were randomized (1:1:1) and treated bilaterally QID for 28 days. Standard DED signs and symptoms were assessed at baseline and after 7 and 28 days of dosing.

Results : The results from pooled data across all treatment arms 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 (ODS) Score (p=0.00002), Overall Four-Symptom (4SS) Score (p=0.0004), Schirmer's Test (p=0.008), tear osmolarity (p=0.003), and Lissamine Green total 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 (MDA), 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. No significant changes in safety measures were observed. 0.1% ADX-102 was identified as the most tolerable formulation, and demonstrated statistically significant improvement from baseline in ODS (p=0.005), 4SS Dryness Score (p=0.01), Schirmer's Test (p=0.04), and tear MDA level (p=0.007). Effect sizes for the symptom scores exceeded 0.5, suggesting that the results were clinically relevant

Conclusions : These results are supportive of the activity of ADX-102 treatment in DED. The 0.1% ADX-102 formulation demonstrated statistically significant and clinically relevant improvement across multiple dry eye disease signs and symptoms, and was selected to advance to dose-ranging Phase 2b in DED.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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