Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease - Seite 2

A clinical trial at a different dry eye chamber, in addition to a traditional six-week field clinical trial, are expected to be conducted in parallel with the planned clinical trial as part of a comprehensive strategy designed to account for disease heterogeneity and potential differences in clinical sites and environment. Consistent with previously disclosed guidance and based on the current operating plan, cash and cash equivalents of $142.8 million as of December 31, 2023 are projected to be sufficient to fund operations beyond 2026.

Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today, March 28, 2024, to discuss the clinical development plan for resubmission of the new drug application for reproxalap in dry eye disease. The dial-in numbers are [phone] for domestic callers and [phone] for international callers. The access code is 515106. A live webcast of the conference call will be available on the Investor Relations page of the company’s website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX‑629, ADX‑246, ADX‑248, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated and metabolic diseases. Our late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of retinitis pigmentosa.

About Reproxalap
Reproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology. Reproxalap is a first-in-class small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory diseases. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.