Aldeyra Therapeutics (NASDAQ:ALDX) CEO Todd Brady provided an update on the company’s late-stage ophthalmology programs and broader pipeline during a fireside chat at Oppenheimer’s 36th Annual Healthcare Life Sciences Conference, with much of the discussion centered on the pending FDA decision for reproxalap in dry eye disease.
Reproxalap approaches March 16 PDUFA date after review extension
Brady said the company is nearing a March 16 PDUFA date for reproxalap, which he described as the lead product candidate and the company’s first potential approval for its RASP inhibitor approach. He reviewed a regulatory history that included a complete response letter (CRL) in 2023 after a trial missed a co-primary endpoint, followed by another CRL that cited a baseline imbalance. Brady characterized the baseline imbalance CRL as unusual and said the company quickly resubmitted because it had additional trials available.
Brady said the company has not provided day-to-day updates on FDA interactions, but noted the current review has been “quiet,” which he said was desirable. He added that he expects the FDA to meet the March PDUFA date.
Positioning in dry eye: rapid onset and potential “redness” labeling
Discussing potential differentiation in the dry eye market, Brady emphasized that existing therapies may take weeks to work, while he said reproxalap has the potential to provide relief within minutes. He also highlighted a potential labeling advantage: reproxalap “has the potential to be the only drug with redness on the label” that can be used chronically, in contrast to steroids that are generally used short-term due to safety concerns.
Brady added that patients may care not only about symptom relief but also about how their eyes look, describing redness reduction as meaningful for patients and for AbbVie, Aldeyra’s partner on reproxalap.
Allergic conjunctivitis: two Phase 3 trials completed and potential SNDA path
Brady said Aldeyra has completed clinical testing in allergic conjunctivitis with two Phase 3 trials, both of which he described as positive. He noted that dry eye disease and allergic conjunctivitis co-occur in about half of patients, and said steroids can be prescribed for short courses but carry risks such as cataracts and glaucoma with longer-term use.
He said reproxalap has the potential to be the only drug approved for both dry eye disease and allergic conjunctivitis, and outlined a pathway in which a dry eye approval could be followed by a supplemental NDA (SNDA) for allergy, potentially adding allergic conjunctivitis to the product label.
AbbVie partnership: option timing and economic terms discussed
Brady said AbbVie holds an option to reproxalap that expires 10 business days after approval. If exercised after approval, he said the deal would provide an effective $200 million upfront, with $6 million already paid—implying $194 million remaining upon opt-in. He described the structure as $100 million to exercise the option and $100 million upon approval.
He also cited two additional $100 million milestones—one tied to sales and one tied to coverage—and said that, given AbbVie’s commercial capabilities, he felt confident about the reimbursement-related milestone. Brady said the arrangement includes a 60/40 split of profit and loss (60% to AbbVie, 40% to Aldeyra), with Aldeyra responsible for 40% of costs to profitability and receiving 40% of profits thereafter, along with an annual cap on Aldeyra’s costs given its size.
ADX-2191 ocular lymphoma trial timeline and ADX-248 atopic dermatitis program
Beyond reproxalap, Brady pointed to ADX-2191, an orphan drug-designated intravitreal methotrexate formulation for primary vitreoretinal lymphoma, which he referred to as ocular lymphoma. He described the disease as fatal and said it can metastasize to the brain. He said the condition is currently treated with compounded methotrexate and emphasized that an approved formulation “does not exist today.”
Brady said Aldeyra has a “one-trial agreement” with the FDA for a single pivotal trial comparing twice-weekly injections of ADX-2191 versus monthly injections, noting that more frequent dosing is associated in the literature with faster cancer clearance. He said he hopes to have data by the end of the year or in the first part of next year, followed by an NDA submission.
On earlier-stage assets, Brady discussed ADX-248 as an oral RASP modulator program for atopic dermatitis, describing it as a more potent “second cousin” of reproxalap suited to once-daily dosing. He said the company is in the middle of Phase 1 and that the drug appears well-tolerated in patients, supporting once-a-day administration. Brady said Aldeyra expects Phase 1 to conclude around mid-year, with Phase 2 planned for the second half of the year and data expected next year. He positioned ADX-248 as potentially addressing a need for oral options for mild-to-moderate atopic dermatitis, particularly for patients who prefer to avoid injectable therapies.
Brady also briefly addressed liquidity, stating the company reported $75 million in cash as of the end of the third quarter, which he said supports roughly two years of runway through the end of next year. He said the cash position covers potential additional dry eye work if needed and supports other programs including ADX-246 in dry age-related macular degeneration. Brady added that an AbbVie option exercise, if it occurs, would further strengthen Aldeyra’s capitalization.
About Aldeyra Therapeutics (NASDAQ:ALDX)
Aldeyra Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule therapies for immune-mediated diseases. The company’s research efforts center on targeted alkenals, a class of reactive aldehyde species that play a key role in inflammatory pathways. By selectively modulating these pathways, Aldeyra aims to address both ocular and systemic indications with high unmet medical need.
The company’s lead product candidate, reproxalap, is being investigated in several ophthalmic disorders, including dry eye disease, allergic conjunctivitis and non-infectious anterior uveitis.
