This article is more than 5 years old. Information may no longer be current.
Aldeyra announces positive results from dry eye treatment trial
Click Here to Manage Email Alerts
A phase 2a clinical trial of topical ocular ADX-102 in patients with dry eye disease showed significant improvements across several sign and symptom endpoints, according to a press release from Aldeyra Therapeutics.
The randomized, dose-ranging, parallel-group, double-masked trial studied three formulations of ADX-102 in 51 patients: 0.1% ophthalmic solution, 0.5% ophthalmic solution and 0.5% lipid formulation.
Over a 28-day treatment period, pooled data results showed a statistically significant improvement from baseline in Symptom Assessment in Dry Eye score (P = .003), ocular discomfort score (P = .00002), overall four-symptom score (P = .0004), Schirmer test (P = .008), tear osmolarity (P = .003), lissamine green ocular surface staining score (P = .002) and tear aldehyde levels (P = .009), the release said.
The trial’s main goal was to select a formulation and dose range for a phase 2b clinical trial, which was determined to be the 0.1% ophthalmic solution. It showed statistical significance for ocular discomfort score (P = .002), the dryness component of the four-symptom score (P = .01), overall four-system score (P = .048), Symptom Assessment in Dry Eye score (P = .09), Schirmer test (P = .04), tear osmolarity (P = .06) and tear aldehyde levels (P = .007), according to the release.
The company expects to initiate the phase 2b clinical trial in the first half of 2018.