Dry Eye Drug Pipeline
Last updated November 2024
This list covers drugs 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.
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Acoltremon is a transient receptor potential melastatin 8 (TRPM8) agonist. It was acquired by Alcon from Aerie.
Alcon has reportedly submitted their NDA (2h 2024) with an expected FDA decision in May 2025.
We also note that they have an active Phase 3b safety trial.
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0.25% topical ocular reproxalap (RASP inhibitor; “rapid onset”) for dry eye disease.
Aldeyra announced in an October 2024 press release that they have resubmitted their NDA.
Phase 3
We list drugs here when they are the subject of one or more active or recently completed Phase 3 clinical trials.
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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.
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Melanocortin receptor pan-agonist
In February 2024, Palatin announced results of its MELODY-1 clinical trial.
In August, 2024, Palatin announced the FDA confirmed acceptability of their remaining Phase 3 clinical trials, MELODY-2 and MELODY-3. They anticipate patient enrollment starting in 4Q 2024 and topline results currently expected in 4Q 2025.
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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.
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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 enrolled its first Phase 3 clinical trial participants in January 2024.
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.”
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Between 2 & 3
We list drugs here if they have completed Phase 2 trials within the past two years but no further activity has been announced yet.
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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.
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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.
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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.
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.
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Data from a Phase 2 study for A-197 was presented at ARVO 2024 (see IOVS abstract).
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GLK-301 is a topical pilocarpine cream (iLution platform) being studied for dry eye disease. A Phase 2a study was completed in 2023.
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“A novel TRPM8 agonist delivered via ophthalmic eyelid wipe, for the treatment of signs and symptoms of dry eye disease”
Phase 1/2 study complete as of 10/2024.
According to a September 17, 2024 press release, they expect topline data in 1Q 2025.
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A Phase 2 trial was completed some time ago for dry eye in primary Sjogrens. Results were published in Cornea in July 2023.
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OKYO Pharma has complete a Phase 2 trial for dry eye disease and is currently recruiting for a new study on corneal neuropathic pain.
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Phase 1/2 trial completed in late 2023 for dry eye disease.
Seinda website currently suggests intention to proceed with development.
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Telios announced results from a proof-of-concept study in March 2024.
A 2b study for dry eye disease is active at clinicaltrials.gov, and another is recruiting for allergic conjunctivitis.
The company’s website does not appear to be active.
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“VSJ-110 is a small-molecule CFTR activator that is being developed as an ophthalmic solution”
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.
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Removed from list on Nov 2024 (phase 2 reported in 2022)
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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.
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