Aldeyra Therapeutics has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for topical ocular reproxalap, to treat signs and symptoms of dry eye disease.
The investigational new drug candidate reproxalap is a first-in-class small-molecule modulator of reactive aldehyde species (RASP) that are elevated in ocular and systemic inflammatory disease.
It represents a new mechanism for diminishing ocular inflammation in dry eye disease.
The company’s NDA submission is supported by the data obtained from five adequate and well-controlled clinical trials that cover data for Schirmer test, ocular dryness symptom score, ocular redness, and Schirmer test ≥10 mm responder analysis.
Aldeyra stated that topical ocular reproxalap was evaluated in over 2,000 patients.
In the clinical trials, no clinically significant safety concerns were observed, and mild and transient instillation site irritation was the most commonly reported adverse event.
Aldeyra president and CEO Todd Brady said: “The NDA submission for reproxalap is, to our knowledge, the most comprehensive regulatory package ever for a dry eye disease drug candidate.
“With data suggesting activity within minutes of administration, reproxalap could provide an important treatment option for the millions of dry eye patients who generally regard currently available therapies as inadequate.”
If approved, reproxalap will become the first marketed RASP modulator.
It is currently in late-stage development for the treatment of allergic conjunctivitis, which is a condition that is commonly related with dry eye disease.
Additionally, results from the Phase III INVIGORATE-2 Trial are anticipated next year.
Aldeyra’s RASP modulator platform includes systemic disease pipeline candidates ADX-629 as well as the related analogs.
ADX-629 has completed proof-of-concept trials for the treatment of Covid-19, psoriasis, and asthma.
It is currently in Phase II clinical trials for minimal change disease, chronic cough, Sjögren-Larsson Syndrome, and alcoholic hepatitis.