Dry Eye Drug Pipeline
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
THE WAITING PHASE
Drugs will show in this list when the company has completed all of the required human clinical trials and has filed its New Drug Application (NDA) or Biologics License Application (BLA) with the FDA. They have probably received their “PDUFA Date” - that is, the deadline by which the FDA must publicly announce a decision. Sometimes this involves one or more response cycles where there FDA requires additional information or even additional studies.
List updated May 2026
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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: Rejected for 3rd time by FDA in 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”.
March 2026: complete response letter again from FDA.
Phase 3
FINAL CLINICAL PHASE
The company is currently conducting Phase 3 clinical trials under the FDA’s oversight, or has completed the trials and is preparing to file its New Drug Application (NDA). Phase 3 clinical trials are conducted on much larger groups of people to confirm the drug’s benefit and compare it to standard-of-care treatments as well as monitor side effects.
List updated May 2026
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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.
A large clinical trial was completed with ~500 patients dosed twice weekly for up to 12 months.
Azura presented several scientific posters at ARVO 2026, which can be downloaded at this link. A strong emphasis is being placed on benefits for contact lens tolerance.
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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 presented a poster at ARVO 2026.
Stuart intends to initiate a Phase 3b trial in the fall of 2026.
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Product: RGN-259 contains the regenerative protein thymosin ß4 and is being developed for neurotrophic keratitis. Unlike Oxervate, it does not require refrigeration.
Company: ReGenTree (RegeneRx US joint venture)
Status: According to clinicaltrials.gov and several academic institution sites. the Phase III clinical trial SEER-2 for neurotrophic keratopathy is currently recruiting.
The company announced that a European clinical trial failed to meet its primary endpoint in a European Phase 3 clinical trial in 2025.
RGN-259 has been studied for dry eye disease in the past.
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Product: Melanocortin receptor pan-agonist.
Company: Palatin
Status: It is unclear whether/when they will be proceeding with further clinical trials.
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 most likely they are still seeking funding to proceed.
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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: Recruiting for PREDICT-1, a phase 2/3 regristrational study, which began in April 2026.
Completed 2b in 2024.
Phase 2
MID-STAGE CLINICAL TESTING
We list drugs here when they are currently conducting or have recently completed a Phase 2 clinical trial. Phase 2 trials focus on treatment efficacy and finding the optimal dosage.
Sometimes drugs stay on this list for a long time because the company has not yet obtained sufficient funding to continue development but hasn’t given up yet. If we can’t obtain any information for a year or more, we typically move them to the graveyard section at the bottom of this page.
List updated June 2026
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Product: Biologic eye drop derived from a fibrinogen-depleted human platelet lysate.
Company: Cambium
Contact: info@cambium.bio
Status: Announced in April 2026 that FDA confirmed a single pivotal phase 3 trial pathway for the drug.
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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: Pending Phase 3 program plans
LATEST NEWS: Announced an agreement with Thea in December 2025.
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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:
A 2b study for dry eye disease is active at clinicaltrials.gov though no longer recruiting. This has been ongoing since 2024.
Telios announced results from a proof-of-concept study in March 2024.
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Product: Plasma-derived immunoglobulin eye drop
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: 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: Urcosimod, a chemerin receptor peptide agonist
Company: Okyo Pharma
Status - NCP:
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;.
Latest news: Jan 2026 Intent to hold SAB meeting to discuss strategic plan for Phase 3.
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 - results have not been announced, though the trial is listed as completed.
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Product: Synthetic peptide fragment of the human tear protein “lacritin”.
Company: Tear Solutions
Current status: Phase 2 clinical trial commenced May 2026.
Company’s dry eye program has not been active in a few years.
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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: Libvatrep, 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.
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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.
LATEST NEWS: None since March 2025 announcement about Type C meeting with FDA.
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Product: Synthetic peptide fragment of the human tear protein “lacritin”.
Company: TearSolutions
Status: 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: GLK-301 is a topical pilocarpine eyelid 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: “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.
Early development
HOPEFULS
We list drugs here if they are believed to be in active development - for example, early safety studies - 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.
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Drug: Platelet-derived regenerative biologic for Sjögrens Dry Eye.
Company: Stellular Bio
Latest: Closed Series 1 financing January 2026.
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In preclinical development of a topical therapeutic for dry eye disease.
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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