ALDX Up as FDA Accepts Resubmitted NDA for Eye Drug Reproxalap

Core Viewpoint - Aldeyra Therapeutics has received FDA acceptance for the resubmitted NDA for reproxalap, a potential treatment for dry eye disease, with a decision expected on April 2, 2025 [1][3]. Company Developments - Aldeyra's shares increased by 11.6% on November 18 following the announcement of the NDA acceptance, and the stock has risen 33.9% year-to-date, contrasting with a 6% decline in the industry [2]. - The company had previously received a complete response letter (CRL) from the FDA in November 2023, indicating that the initial study results did not demonstrate the efficacy of reproxalap for treating dry eye symptoms [3][4]. - In response to the CRL, Aldeyra initiated a dry eye chamber clinical study to address the FDA's concerns, enrolling the first patient in May 2023 [5][4]. - The phase III dry eye chamber study met its primary endpoint, showing that reproxalap was statistically superior to the vehicle for ocular discomfort, an FDA-accepted symptom of dry eye disease [6]. Collaboration with AbbVie - Aldeyra has expanded its option agreement with AbbVie, where Aldeyra will cover 40% of certain pre-commercial activities, while AbbVie will bear the remaining 60% if the option is exercised [8]. - Under the agreement, if AbbVie exercises the option, Aldeyra could receive an upfront payment of $100 million, minus previously paid option fees of$6 million, and up to $300 million in regulatory and commercial milestone payments, including$100 million upon potential FDA approval [10]. - The profit-sharing arrangement stipulates that Aldeyra will receive 40% of the profits from the commercialization of reproxalap, while AbbVie will receive 60% [11].