Aldeyra Therapeutics has announced positive results from their phase 2a clinical trial investigating the optimal dose of the dry eye treatment candidate, ADX-102.
The topical agent is a small molecule aldehyde trap that inhibits the actions of fatty aldehydes involved in ocular inflammation.
Pooled data from 3 dosage groups demonstrated significant improvements across multiple sign and symptom endpoints: mean patient-reported discomfort and symptom scores, tear volume, tear osmolarity and ocular surface staining scores. According to the company's press release, most benefits were evident within a week of therapy. The 28-day trial randomized 51 dry eye disease patients to ADX-102 as a 0.1% ophthalmic solution, 0.5% ophthalmic solution or 0.5% lipid formulation. There was no control group.
Aldeyra also reported that treatment effect increased with duration of therapy, and that a modest dose-response was observed. Furthermore, levels of malondialdehyde, a pro-inflammatory aldehyde mediator sequestered by ADX-102, were significantly reduced in the tears of patients (P=0.009), confirming the functionality of the agent’s unique mechanism of action.
"ADX-102 is a promising agent for the treatment of dry eye disease, a persistently challenging condition for many people worldwide," said John Sheppard, MD, an investigator on ADX-102 trials. "The evidence of rapid-onset activity and the tolerability profile demonstrated in the Phase 2a clinical trial suggests that ADX-102 could provide important patient benefits relative to existing therapies."
The company expects to initiate the phase 2b clinical trial in the first half of 2018.
Separately, a phase 2 trial assessing ADX-102 for allergic conjunctivitis showed that the drug offered comparable benefit to corticosteroids, but ultimately failed to significantly improve eye itching over placebo in a subsequent phase 2b trial.