Drug Pipeline
This is a list of drugs in advanced development for Dry Eye Disease or related indications, based upon publicly available information.
Please contact Dry Eye Foundation with additions, updates or corrections.
Last updated: September 30, 2023
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Below is a list of drugs for which the “New Drug Application” (NDA) - or, in the case of a biologic, “Biologics License Application” (BLA) has been submitted and the company is awaiting the FDA’s decision. NDA (or BLA) is the last step in the drug approval process and it means that the company has completed all of the required human clinical trials under the agency’s oversight and is awaiting final regulatory review.
REPROXALAP (Aldeyra)
0.25% topical ocular reproxalap (RASP inhibitor; “rapid onset”) for dry eye disease. NDA filed November 2022.
PDUFA Date: November 23, 2023
UPDATE: Unfortunately, things are not looking promising for Reproxalap as of October 16. Read more
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This is a list of drugs with active or recently completed Phase 3 human clinical trials.
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OCS-02 (Oculis) - Licaminlimab
OK-101 (OKYO Pharma) - being studied for dry eye and also for corneal neuropathic pain
SURF-100, SURF-200 (Surface Ophthalmics)
AZR-MD-001 (Azura Therapeutics - Selenium sulphide ointment)
SkQ1 / Visomitin (Mitotech)
Lacripep (Tear Solutions)