Dry Eye Drug Pipeline

Last updated May 7, 2024

This is a list of drugs being developed for Dry Eye Disease or related indications and specifically for the US market.

Please contact Dry Eye Foundation with additions, updates or corrections.

NDA

Drugs are listed here if the company has filed its New Drug Application (NDA) or Biologics License Application (BLA) with the FDA.

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.

  • What it is: 0.25% topical ocular reproxalap (RASP inhibitor; “rapid onset”) for dry eye disease.

    Aldeyra filed their NDA in November 2022. The FDA flagged “substantive” issues wih their data.

    According to a March 2024 press release, Aldeyra “intends to initiate a dry eye chamber clinical trial in the first half of 2024. Contingent on positive results from the planned clinical trial, NDA resubmission is expected in the second half of 2024. Based on FDA guidance, the planned review period for the potential NDA resubmission is expected to be six months.”

Phase III

Drugs are listed here if they are the subject of one or more active Phase III clinical trials or if a Phase III clinical trial has recently been completed.

  • What it is: Transient receptor potential melastatin 8 (TRPM8) agonist

    In January 2024, Alcon announced positive results from its COMET-2 and COMET-3 clinical trials.

  • What it is: Melanocortin receptor pan-agonist

    In February 2024, Palatin announced results of its MELODY-1 clinical trial.

  • What it is: vezocolmitide, “based on PolyCol, the company's synthesized polypeptide technology that mimics amino acid sequences found in collagen”

    According to news reports, Stuart Therapeutics enrolled its first Phase III clinical trial participants in January 2024.

  • What it is: RGN-259 contains the regenerative protein thymosin ß4

    According to clinicaltrials.gov, the Phase III clinical trial SEER-2 is ongoing.

Phase II

Drugs are listed here if they are the subject of one or more active Phase II clinical trials or if a Phase II clinical trial has recently been completed

  • SAF-312 is being developed for post-operative corneal pain.

    According to clinicaltrials.gov, two clinical trials were completed, the most recent a Phase II trial completed in summer 2023.

Early development

Drugs are listed here if they have not yet commenced a Phase II human clinical trial or if their developme

Graveyard?

Drugs are listed here if there has been no recent publicly available evidence of continued development.