Dry Eye Drug Pipeline
Updated December 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
ALMOST THERE! 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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Product: 0.25% topical ocular reproxalap (RASP inhibitor; “rapid onset”) for dry eye disease.
Company: Aldeyra Therapeutics; Abbvie has an exclusive option.
Status: Next FDA response March 2026.
Reproxalap has been in the drug approval process since 2022.
Nov 2022 - 1st NDA submission
Nov 2023 - signed option with Abbvie
Nov 2023 - complete response letter from FDA ; they failed to prove that Reproxalap improves patient symptoms and would have to conduct another trial. FDA agreed to a dry eye chamber trial.
Oct 2024: Aldeyra resubmits NDA.after announcing successful results in August.
Apr 2025: complete response letter from FDA, rejecting it again based on methodological issues in patient symptom data
June 2025: Aldeyra resubmits.
December 2025: complete response letter from FDA, extending PDUFA data, after requesting data on a “field trial”.
Phase 3
THE EXPENSIVE PHASE: 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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Product: selenium sulfide ointment to treat MGD.
Company: Azura Ophthalmics.
Status: Azura announced on 12/10/25 after a positive FDA meeting that they expect to submit an NDA in 2h2026.
As of 12/2025, a large clinical trial is currently underway with ~500 patients dosed twice weekly for up to 12 months.
Primary outcome measures: (1) Change from baseline in MGYLS (meibomian glands yielding liquid secretion) ; (2) change from baseline in OSDI score, both at month 3.
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Product: 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.
Company: Stuart Therapeutics
Status: Stuart Therapeutics announced initial results from its Phase 3a clinical trial on 6/24/25., describing it as fast-acting, with improvement to both signs and symptoms in 2-4 days
They intend to initiate a Phase 3b trial in mid 2026.
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Product: RGN-259 contains the regenerative protein thymosin ß4 and is being developed for dry eye disease and neurotrophic keratitis.
Company: ReGenTree (RegeneRx US joint venture)
Status: 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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Product: Melanocortin receptor pan-agonist.
Company: Palatin
Status: Palatin announced results from MELODY-1 in May 2025, emphasizing their multiple symptom endpoint data. They have not yet commenced MELODY-2/3, despite FDA confirming acceptability in 2h2024, so presumably they are currently seeking funding to proceed.
Phase 2
SO MANY POSSIBILITIES: We list drugs here when they are the subject of one or more active or 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 eventually remove them from the list.
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Product: “Precision medicine” licaminlimab. Described as “an anti-TNFα eye drop candidate specifically designed to treat ocular inflammation.”
Company: Oculis
Status: Completed 2b in 2024.
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Product: Biologic eye drop derived from a fibrinogen-depleted human platelet lysate.
Company: Cambium
Contact: info@cambium.bio
Status: Announced 2/27/25 that FDA has approved Phase 3 clinical protocol; has announced further approvals and funding since then.
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Product: Topical immunomodulator being developed for auto-immune associated dry eye.
Company: Iolyx and Thea (strategic agreement announced 12/3/2025)
Status: Iolyx announced Phase 2 results 5/27/2025.
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Product: Pro-Ocular is a progesterone cream applied to the forehead.
Company: Signal 12
Status: Signal 12 has completed multiple clinical trials and they are seeking funding to proceed to Phase 3 clinical trials for oGvHD. Label extensions could include Sjôgrens and others.
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Product: Synthetic peptide fragment of the human tear protein “lacritin”.
Company: TearSolutions
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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Product: Urcosimod
Company: Okyo Pharma
Status:
Company announced new data showing favorable corneal nerve outcomes in Phase 2 study
FDA awarded Fast Track designation to this drug in May 2025. A clinical trial for corneal neuropathic pain was terminated early with strong results; the company plans to proceed to a multiple-ascending dose (MAD) clinical trial next.
Status - dry eye:
OKYO Pharma completed a Phase 2 trial for dry eye disease in 2023. No further steps have been announced for further study of this indication, though in mid 2024 they announced that a patent was granted covering its potential for treating symptoms of DED.
On January 23, 2026, OKYO announced that the FDA has authorized compassionate use of Urcosimod for a patient with neuropathic corneal pain.
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Product: “A novel TRPM8 agonist delivered via ophthalmic eyelid wipe, for the treatment of signs and symptoms of dry eye disease”
Company: iview Therapeutics
Status: Phase 2b trial currently underway
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Product: a Bruton’s tyrosine kinase inhibitor; emulsion
Company: Telios Pharma. The company’s website does not appear to be active.
Status: Telios announced results from a proof-of-concept study in March 2024.
A 2b study for dry eye disease is active at clinicaltrials.gov.
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Product: Small-molecule CFTR activator (ophthalmic solution)
Company: Vanda
Status: Apparently recruiting for Phase 2 trial. However, the Vanda website does not show anything for dry eye on their pipeline page.
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Product: Immunoglobulin drops
Company: Grifols (prev. Selagine?)
Status: Recruiting
December 2025 update: Phase 2 clinical trial now recruiting. GRF312 5%. 7 sites in the US.
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Product: “accelerates healing by repairing DNA in ocular cells”. It is described as being “derived from a naturally occurring small molecule that modulates the activity of three parallel enzyme systems that are critical to innate immune response.”
Company: Invirsa Inc an Ohio LifeSciences startup.
Status: Negotiated path to approval with FDA.
Invirsa (an Ohio Life Sciences startup) completed a two-part study in 2024. Part 1, Part 2.
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Product: GLK-301 is a topical pilocarpine cream (iLution platform) being studied for dry eye disease
Company: Glaukos
Status: No action on this since completion of a Phase 2a study in 2023 with positive results announced. However, a 3Q2025 investor presentation still listed it as Phase 2.
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Product: Peptide
Company: Seinda Therapeutics
Status: Results of Phase 1/2 trial completed in late 2023 were presented at ARVO 2025.
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Product: Libvatrip, a topical TRPV1 agonist being developed for post-operative corneal pain.
Company: Bausch & Lomb (acquired in 2023 from Novartis)
Status: 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.
Early development
We list drugs here if they are believed to be in active development but have not yet commenced a Phase 2 human clinical trial. If you know of something that should be added to this list please contact us.
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Product: hepatocyte growth factor ophthalmic solution
Company: Claris Bio
Status: Phase 1/2 study completed 2024. New study currently recruiting.
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Removed from active development list Dec 2025. Company reportedly liquidating.
Graveyard?
We list drugs here when the developer has announced discontinuation of the program or if quite some time has passed without any evidence of continued development. If you see something here that you know to be in active development, please contact us.
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Product: Tanfanercept
Company: Hanall
Status: VELOS-4 trial suspended
The most recent news on this was a May 2024 press release indicating the VELOS-4 clinical trial for HL-036 (tanfanercept, a TNF inhibitor protein) 0.25% eye drops was initiated for dry eye disease. However, the trial was apparently suspended shortly after.
However, ClinicalTrials.gov is currently showing this clinical trial as suspended.
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Removed from active pipeline Dec 2025.
Product: Topical immunomodulatory
Company: Aramis
Status: Data from a Phase 2 study for A-197 was presented at ARVO 2024 (see IOVS abstract).
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Removed from active pipeline Dec 2025.
Product: Peptide
Company: Seinda Therapeutics
Status: Results of Phase 1/2 trial completed in late 2023 were presented at ARVO 2025.
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Removed from active pipeline Dec 2025.
Product: Tivanisiran
Company: Sylentis
Status:
As of 12/2025, no news since FYDES study completed.
2024: Phase 3 safety study for dry eye completed
2024: Phase 3 study for Sjogrens completed
2018: Phase 3 complete for dry eye
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Product: formyl peptide receptor agonist
Company: Allgenesis. Website currently not responding.
Status: Study completed 2022.
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Removed from list on Nov 2024 (phase 2 reported in 2022, company website has no dry eye activity)
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Removed from active development list Dec 2025. Company reportedly liquidating.
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Removed from active development list Dec 2025 due to lack of activity
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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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