Aldeyra’s reproxalap for dry eye disease accepted by FDA
Biotech Aldeyra Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate for treatment of the signs and symptoms of dry eye disease.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of 23rd November 2023. No potential filing review issues have been identified, according to the FDA, and there is no advisory committee currently planned.
Dry eye disease is a common inflammatory disease estimated to affect over 39 million adults in the US. It is characterised by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life and, in severe cases, permanent visual impairment.
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, small-molecule RASP (reactive aldehyde species) may contribute to ocular inflammation, diminished tear production, ocular redness, and changes in tear lipid composition.
Topical ocular reproxalap has been studied in more than 2,000 patients with no observed clinically significant safety concerns, apart from mild and transient instillation site irritation, which was the most commonly reported adverse event in clinical trials. By diminishing RASP levels, Aldeyra’s RASP modulator reproxalap aims to offer an alternative treatment to patients. Furthermore, its mechanism of action has been supported by demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct, late-phase clinical indications.
The NDA for reproxalap is supported by previously announced safety and efficacy results from five adequate and well-controlled clinical trials encompassing data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis.
The NDA also includes activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings.
Dr Todd C. Brady, president and CEO of Aldeyra, said: “NDA acceptance marks a critical regulatory milestone for Aldeyra, as reproxalap continues to advance towards potential regulatory approval for the treatment of dry eye disease.
Brady continued: “Based on data from a number of late-stage clinical trials, we believe reproxalap has the potential to address the need for a rapid and durable ophthalmic therapy for the millions of dry eye disease patients who are dissatisfied with currently available therapies.”
In January 2022 – after prospects for reproxalap had been hit at the end of 2021, after the drug failed to hit its primary objective in a phase 3 trial – Aldeyra didn’t give up, subsequent data showing an improvement over Novartis rival therapy Xiidra.
And that dogged persistence had paid off by September 2022, when the company met with the FDA to discuss the programme.
Meanwhile, in other ophthalmic developments, in October 2022 pharmaphorum spoke with Dr Charles C. Wykoff about the results from Apellis Pharmaceuticals’ OAKS study on intravitreal pegcetacoplan for geographic atrophy (GA), otherwise known as atrophic or dry age-related macular degeneration (AMD), a leading cause of blindness worldwide.