Aldeyra Therapeutics, Inc.

Overview

Aldeyra Therapeutics is a biotechnology company developing immune‑modulating therapies based on reactive aldehyde species (RASP) modulation. The strategy focuses on modulating multiple inflammatory pathways rather than single‑target inhibition. The lead programs include reproxalap (topical ocular), ADX‑2191 (intravitreal methotrexate), and next‑generation RASP modulators (ADX‑248 oral; ADX‑246 intravitreal). ADX‑629, an oral systemic RASP modulator, was discontinued in 2025. The company plans to license, partner, or collaborate for commercialization; AbbVie holds an exclusive option under an option agreement.

Lead programs

• Reproxalap (topical RASP modulator for ocular use)

  • Indications: dry eye disease and allergic conjunctivitis.
  • Regulatory status: NDA submitted December 2022; FDA issued Complete Response Letters in 2023 and 2025. The 2025 CRL stated there was not adequate, well‑controlled evidence of efficacy for ocular symptoms of dry eye and required an additional adequate, well‑controlled study. The second NDA resubmission was accepted and assigned a PDUFA date that was later extended; a field trial was requested and the target action date was extended to March 16, 2026.
  • Clinical highlights: Two chamber trials showed activity for reducing ocular discomfort (first chamber P = 0.004; second chamber P = 0.002). A supporting field trial did not reach statistical significance but was supportive of activity.
  • Commercialization: AbbVie has an option to co‑develop/co‑commercialize in the U.S. and to obtain exclusive outside‑U.S. rights. AbbVie had not exercised the option as of February 27, 2026.

• ADX‑2191 (intravitreal methotrexate formulation)

  • Indications: primary vitreoretinal lymphoma (PVRL) and retinitis pigmentosa (RP).
  • Regulatory status and designations: FDA Orphan Drug Designations; Fast Track designation for RP; EMA orphan designations. SPA discussions referenced for PVRL and RP trials. A Phase 2/3 approach for RP is contemplated per FDA feedback.
  • Clinical highlights: Phase 2 RP results observed improvements in visual function in eight RP patients.
  • Development plan: Phase 2/3 trial in RP planned for 2026.

• ADX‑248 and ADX‑246

  • ADX‑248: oral next‑generation RASP modulator; Phase 1 ongoing.
  • ADX‑246: intravitreal next‑generation RASP modulator; Phase 1 planned to initiate in 2026–2027.

Scientific platform

The RASP platform targets multiple inflammatory signaling pathways by covalently binding reactive aldehyde species and promoting their degradation to lower RASP levels. The approach emphasizes fast onset, safety profile, and reduced reliance on single‑target mechanisms.

Collaborations and license agreements

• AbbVie Option Agreement (effective October 31, 2023)

  • Rights: AbbVie holds an exclusive option for a co‑exclusive U.S. license to develop, manufacture, and commercialize reproxalap in the U.S., and an exclusive license outside the U.S. It also has a right of first negotiation for certain ocular surface compounds and data review rights for other ophthalmology/immunology compounds.
  • Payments: AbbVie paid a $1.0 million non‑refundable upfront option payment and a $5.0 million non‑refundable option extension fee in December 2023.
  • Expansion Side Letter (November 15, 2024): If AbbVie exercises the option, AbbVie will reimburse 60% of allowable launch expenses upon entry into the Collaboration Agreement. If AbbVie does not exercise, Aldeyra will bear those costs.
  • Exercise and economics: Exercise period is tied to the FDA NDA decision on reproxalap for dry eye. Upon exercise and execution of the Collaboration Agreement, AbbVie would pay an upfront cash payment of $100 million (net of prior option payments) and potential regulatory/commercial milestones up to approximately $300 million, including a $100 million milestone tied to an FDA decision. U.S. profits/losses would be split 60% to AbbVie and 40% to Aldeyra; outside the U.S., tiered royalties on net sales would apply.
  • Status: AbbVie had not exercised the option as of February 27, 2026.

• MEEI Agreement

  • Aldeyra holds an exclusive worldwide license under Massachusetts Eye and Ear Infirmary patents to develop and commercialize ADX‑2191. The license includes ongoing payments, royalties, and diligence milestones. Aldeyra assumed this agreement as part of the Helio acquisition.

Intellectual property

Aldeyra’s U.S. patent portfolio includes 34 granted patents, 10 U.S. non‑provisional applications, and two U.S. provisional applications, with foreign counterparts. Reproxalap composition‑of‑matter patents are granted in multiple countries; U.S. composition‑of‑matter patent expiration is expected in 2028 with potential Hatch‑Waxman extension of up to five years. The company holds exclusive license rights for ADX‑2191 formulations and retinal uses.

Manufacturing and operations

Aldeyra relies on third‑party contract manufacturers for raw materials, drug substance, and finished drug product for preclinical and clinical development. The company has no in‑house manufacturing facilities and intends to contract with CMOs for any commercial‑scale manufacturing if a product is approved. The company faces risks related to reliance on a limited number of CMOs, foreign manufacturing sites, scale‑up, and potential regulatory inspection issues.

Employees and corporate resources

• Full‑time employees: 8 as of December 31, 2025; additional personnel engaged via consultants.
• Common stock outstanding: 60,182,782 shares as of February 27, 2026.
• Market value context: Non‑affiliate market value of common stock was approximately $231,896,127 as of June 30, 2025.

Financial snapshot

• Product revenue: No approved products and no product sales revenue.
• Operations: The company has reported ongoing operating losses and expects to incur losses while advancing development programs.
• Funding: The company expects to raise additional capital through debt, equity, or partnering to fund continued development and potential commercialization.
• AbbVie option payments: $6.0 million received to date ($1.0 million upfront and $5.0 million extension). Potential AbbVie payments upon exercise include a $100 million upfront (net) and up to roughly $300 million in milestones.

Summary

Aldeyra is advancing multiple ophthalmic and retinal product candidates based on RASP modulation, with reproxalap as the most advanced program in late‑stage ocular development. The AbbVie option provides a defined path for potential co‑development and commercialization with material upfront and milestone economics if exercised. The company operates with a small staff, relies on third‑party manufacturing and external financing, and maintains a sizeable patent portfolio covering reproxalap and related RASP modulators.