13 September 2017 - - Lexington, Massachusetts-based aldehyde-related disease specialist Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) has announced positive results from a Phase 2a clinical trial of topical ocular ADX-102 in patients with dry eye disease, the company said.
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 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.
There were no safety concerns observed for any of the formulations of ADX-102, and no serious adverse events were reported.
Aldeyra Therapeutics a biotechnology company focused on the development of products for inflammation, inborn errors of metabolism, and other diseases, in the United States and internationally. It is devoted to inventing, developing and commercializing products that treat diseases thought to be related to endogenous aldehydes, a naturally occurring class of pro-inflammatory and toxic molecules.