Topical treatment for dry eye confers positive phase 2a results

In a phase 2a trial, a topical treatment for patients with dry eye disease significantly improved symptoms, according to a press release from Aldeyra Therapeutics.

The treatment, ADX-102 (Aldeyra), was assessed in a dose-ranging randomized trial. Participants (N = 51) were randomized to one of three formulations of ADX-102 (0.1% ophthalmic solution, 0.5% ophthalmic solution or 0.5% lipid formulation) for 28 days.

Participants reported statistically significant symptom improvement from baseline in symptom assessment in dry eye score (P = .003), ocular discomfort score (P = .00002), overall four-symptom score (P = .0004), Schirmer’s (tear volume) test (P = .008), tear osmolarity (P = .003) and lissamine green ocular surface staining score (P = .002). Improvements were seen as early as 1 week.

A modest dose-dependent response was observed.

No safety concerns were observed and no adverse events were reported.

“ADX-102 is a promising agent for the treatment of dry eye disease, a persistently challenging condition for many people worldwide,” John Sheppard, MD, professor of ophthalmology at Eastern Virginia Medical School, said in the release. "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."

Based on the results of the study, the 0.1% ophthalmic solution formulation was selected for future testing.