Aldeyra Therapeutics (ALDX) investor relations material

Regulatory and partnership updates

• Awaiting a PDUFA decision for reproxalap in dry eye disease on December 16, with a potential $194 million partnership option from AbbVie if approved, including $100 million upfront and another $100 million post-approval.

• AbbVie has 10 business days post-approval to exercise its co-promotion option, with a 60/40 U.S. P&L split and capped losses, plus additional $100 million milestones for sales and insurance coverage.

• Joint management committee ensures balanced spending, with profitability expected in 2–4 years and deferred losses paid as profits accrue.

Market positioning and product differentiation

• Reproxalap offers rapid onset and anti-redness benefits, distinguishing it from existing dry eye therapies that require weeks to show effect.

• Unique efficacy demonstrated in a dry eye chamber, with commercial appeal due to immediate symptom relief and cosmetic improvement.

• Payer research and pricing groundwork have been conducted, with expectations of broad coverage and minimal step-through requirements due to patient dissatisfaction with generics.

Pipeline and future indications

• Plans to pursue allergic conjunctivitis as a supplemental indication, supported by pivotal phase 3 Invigorate 1 and 2 trials showing efficacy in reducing ocular itching.

• NDA filing for allergy indication could occur as early as 2026, potentially making reproxalap the only drug approved for both dry eye and allergic conjunctivitis.

• Pipeline includes programs in atopic dermatitis and dry AMD/geographic atrophy, targeting unmet needs for mild to moderate patients and leveraging oral therapies.