Lifitegrast
- Generic Name
- Lifitegrast
- Brand Names
- Xiidra
- Drug Type
- Small Molecule
- Chemical Formula
- C29H24Cl2N2O7S
- CAS Number
- 1025967-78-5
- Unique Ingredient Identifier
- 038E5L962W
- Background
Lifitegrast is a FDA approved drug for the treatment of keratoconjunctivitis sicca (dry eye syndrome). It is a tetrahydroisoquinoline derivative and lymphocyte function-associated antigen-1 ( LFA-1) antagonist that was discovered through the rational design process. The ophthalmic solution was approved in July, 2016 under the trade name Xiidra. It has shown to protect the corneal surface and alleviate the symptoms of dry eye syndrome with fast onset of action and well tolerated profile in both local and systemic setting .
- Indication
适用于治疗干眼病（DED）的症状和体征。
- Associated Conditions
- Dry Eye Syndrome (DES)
FDA Accepts Aldeyra's Reproxalap NDA for Dry Eye Disease with AbbVie Collaboration
• The FDA has accepted Aldeyra Therapeutics' New Drug Application (NDA) for reproxalap, a topical ocular therapy for dry eye disease, with a PDUFA date of April 2, 2025.
• Reproxalap, a first-in-class RASP modulator, has demonstrated significant clinical efficacy and safety in reducing the signs and symptoms of dry eye disease in multiple late-stage trials.
• Aldeyra has expanded its collaboration with AbbVie to accelerate pre-commercial activities, with AbbVie covering 60% of the costs and a potential $100 million upfront payment upon exercising its option.
• The partnership includes up to $300 million in milestone payments and a profit-sharing model for U.S. commercialization, positioning reproxalap as a potential game-changer in dry eye disease treatment.
Aldeyra Therapeutics Resubmits NDA for Reproxalap for Dry Eye Disease Treatment
• Aldeyra Therapeutics has resubmitted its New Drug Application (NDA) to the FDA for reproxalap, targeting the signs and symptoms of dry eye disease (DED).
• The resubmission includes positive Phase 3 clinical trial results demonstrating reproxalap's superiority over vehicle in reducing ocular discomfort.
• The NDA also contains a draft label reflecting acute and chronic activity in reducing dry eye symptoms and ocular redness in clinical trials.
• If approved, reproxalap could be the first DED therapy for chronic use with pivotal data demonstrating acute activity in symptom reduction.
Drug Development Updates
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