Policy & Regulation
Aldeyra Therapeutics Touts Positive Top-Line Data from Phase 2 Dry Eye Chamber Clinical Trial of Reproxalap, an Investigational New Drug, Compared to Xiidra
13 January 2022 - - US-based biotechnology company Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) has posted positive top-line data from a Phase 2 clinical trial comparing ocular discomfort and itching symptom scores of reproxalap ophthalmic solution 0.25% (reproxalap), an investigational new drug, versus Xiidra (lifitegrast ophthalmic solution 5%) in patients with dry eye disease, the company said.

Patient-reported ocular discomfort (p=0.002) and itching (p=0.01) were statistically lower with reproxalap than with Xiidra.

The double-masked, crossover, single-center, Phase 2 clinical trial in 56 dry eye disease patients evaluated the activity of reproxalap compared to Xiidra for two endpoints: ocular discomfort symptom score and ocular itching symptom score.

A single dose of test article was administered to both eyes approximately 5 minutes prior to a dry eye chamber exposure lasting 45 minutes, during which humidity was maintained at low levels in a setting of regulated air flow, temperature, and visual tasking.

Symptoms were assessed approximately 15 minutes prior to chamber entry, and every 5 minutes beginning five minutes after chamber entry.

No safety signals were observed in the trial, and there were no treatment-related discontinuations or moderate or serious adverse events related to drug. The most common adverse event in both treatment arms was mild instillation site discomfort.

Reproxalap has now been evaluated in more than 1,500 patients. The approved commercial dosing regimen of Xiidra and the intended commercial dosing regimen of reproxalap include repeated administration of drug.

Aldeyra plans to present data from the trial at an upcoming medical meeting.

Reproxalap, an investigational new drug, is a novel small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.

Reproxalap's mechanism of action has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications.

Reproxalap is currently in Phase 3 clinical development as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology.

Dry eye disease is a common inflammatory disease estimated to affect 34 m or more adults in the United States.

The disease is characterized by insufficient lubrication of the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment.

Among many physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate and often requires weeks or months to demonstrate activity.

In patients with dry eye disease, pro-inflammatory RASP may contribute to ocular inflammation and changes in tear lipid composition.

By diminishing RASP levels, Aldeyra's lead RASP modulator reproxalap represents a novel and differentiated approach for the treatment of the symptoms and signs of dry eye disease.

Aldeyra Therapeutics discovers and develops innovative therapies designed to treat immune-mediated diseases.