Dry Eye Drug Pipeline

Last updated April 2025

This list covers drugs (and some devices) being developed for the US market for Dry Eye Disease, MGD, ocular pain or related ocular surface disease indications.

We gather this information from clinicaltrials.gov, company websites and press releases. We cannot guarantee completeness or accuracy. Please contact Dry Eye Foundation if you have newer information to share.

NDA

We list drugs here when the company has filed its New Drug Application (NDA) or Biologics License Application (BLA) with the FDA.

NDA (or BLA) is the final step in the drug approval process. It means that the company has completed all of the required human clinical trials conducted under the agency’s oversight and is awaiting final regulatory review.

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

    Aldeyra resubmitted their NDA in October 2024, but it was rejected by FDA in April 2025. More trial data is expected to be released soon and they are reported to be planning to re-file in the second half of 2025.

Phase 3

We list drugs here when they are the subject of one or more active or recently completed Phase 3 clinical trials.

  • Vezocolmitide. “…Based on PolyCol, the company's synthesized polypeptide technology that mimics amino acid sequences found in collagen”. ST-100 is being developed for dry eye disease.

    Stuart Therapeutics announced completion of its first Phase 3 clinical trial in Jan 2025 and topline results are expected in February.

    From Stuart’s pipeline page:

    “The ST-100 drug candidate has shown in a clinical trial setting that it appears to both relieve symptoms of the disease, but also restore nerve function, resulting in improvements in the lacrimal functional unit, or tear process. Patient relief appears to begin as soon as the second day of use, with a vastly superior speed of action compared to competing therapeutics.”

  • Melanocortin receptor pan-agonist

    In August, 2024, Palatin announced the FDA confirmed acceptability of their remaining Phase 3 clinical trials, MELODY-2 and MELODY-3. They anticipated patient enrollment starting in 4Q 2024 and topline results currently expected in 4Q 2025.

    In April 2025, they released updated results from MELODY-1 about their symptom results, which include 13 symptom endpoints.

    We have not seen any indication yet that MELODY 2/3 have commenced.

  • According to a May 2024 press release, the VELOS-4 clinical trial for HL-036 (tanfanercept, a TNF inhibitor protein) 0.25% eye drops was initiated this year for dry eye disease.

    However, ClinicalTrials.gov is currently showing this clinical trial as suspended.

  • RGN-259 contains the regenerative protein thymosin ß4 and is being developed for dry eye disease and neurotrophic keratitis.

    According to clinicaltrials.gov, the Phase III clinical trial SEER-2 for neurotrophic keratitis is currently recruiting.

    See RegeneRx’ pipeline page for more information.

Between 2 & 3

We list drugs here if they have completed Phase 2 trials within the past two years but have not yet commended Phase 3.

  • OCS-02 is described as “an anti-TNFα eye drop candidate specifically designed to treat ocular inflammation, has the potential transform the treatment paradigm of DED with a precision medicine strategy.”

    Oculis has completed two Phase 2 clinical trials, one for dry eye disease and one for severe dry eye disease.

  • Pro-Ocular is a progesterone cream applied to the forehead.

    Signal 12 has completed three Phase 2 studies and they are seeking funding to proceed to Phase 3 clinical trials for dry eye, Sjogrens and oGvHD.

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

    A Phase 2 trial was completed for eye pain following PRK, and another was completed for “post operative corneal induced chronic pain”. These were completed in 2023 around the time that Bausch acquired Novartis’ ophthalmics portfolio and nothing new has been announced since then.

  • Announced 2/27/25 that FDA has approved Phase 3 clinical protocol.

    Co-primary endpoints: Corneal fluorescein staining, “eye discomfort score”.

    info@cambium.bio

Phase 2

We list drugs here when they are the subject of one or more active or recently completed Phase 2 clinical trials.

Note: Many companies conduct a single Phase 2 for dry eye and are never heard from again. It’s usually a molecule being developed for multiple indications that just doesn’t happen to perform well enough for dry eye. We typically remove them from the list when they’ve gone quiet for a year or more.

Early development

We list drugs here if they are believed to be in active development but have not yet commenced a Phase II human clinical trial.

Graveyard?

We list drugs here when the developer has announced discontinuation of the program or if there has been no recent publicly available evidence of continued development. If you see something here that you know to be in active development, please contact us.

  • Removed from list on Nov 2024 (phase 2 reported in 2022)

  • Intracanalicular inserts with dexamethasone and cyclosporine respectively. While both have completed a phase 1/2 trial, these products are no longer listed on Ocular Therapeutix’ pipeline page.