TheraRadar
Data updated: May 26, 2026

VEVYE (cyclosporine)

Calcineurin Inhibitors
Ophthalmology Approved 2023-05-30

Vevye is an ophthalmic solution used to help patients with dry eye disease. It treats the various signs and symptoms associated with the condition to improve ocular health. This medication is typically prescribed for individuals experiencing chronic dryness and irritation in the eyes.

Source: FDA Label • HARROW EYE • Calcineurin Inhibitor Immunosuppressant
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How VEVYE Works

This medication works by acting as a calcineurin inhibitor, which provides a relatively selective immunomodulatory effect. As an immunosuppressant, it helps regulate the immune response to manage the underlying symptoms of the disease.

Source: FDA Label
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-05-30
Patent Cliff
2042

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Patent cliff and revenue data

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Routes
OPHTHALMIC
Dosage Forms
SOLUTION

Companies

HARROW EYE
Active Ingredient: CYCLOSPORINE

VEVYE Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2023 to 2025
Sep 2025 SUPPL
Label · Labeling
FDA Letter Label
May 2024 SUPPL
Label · Labeling
FDA Letter Label
May 2023 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What VEVYE Treats

1 indications

VEVYE is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Dry Eye Disease
Source: FDA Label

VEVYE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

3

Same target(s), different indications — where else is this mechanism being explored?

PIMECROLIMUS
Teva
2018 1 indic.
ELIDEL
BAUSCH
2001 1 indic.

Indication competitors

6

Same indication, different mechanism — what else might this patient receive?

TRYPTYR
Novartis
2025 1 indic.
MIEBO
BAUSCH AND
2023 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to VEVYE

3 of 5

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

EYSUVIS
LOTEPREDNOL ETABONATE
1 shared
Novartis
Shared indications:
Dry Eye Disease
MIEBO
PERFLUOROHEXYLOCTANE
1 shared
BAUSCH AND LOMB INC
Shared indications:
Dry Eye Disease
TRYPTYR
ACOLTREMON
1 shared
Novartis
Shared indications:
Dry Eye Disease
View all 5 similar drugs Pro
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Clinical Trial Registry

121 trials
Trial Sponsor ID Phase Status Title
NCT07566377 26-168 Ph 2 recruiting Cord Blood Transplantation in Children and Young Adults With Blood Cancer
NCT04888741 MoTD RG_19-116 Ph 2 recruiting Methods of T Cell Depletion Trial (MoTD)
NCT01231412 results posted 2448.00 NCI-2010-02035, 2448.00 Ph 3 completed Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant
NCT01624805 2012-0334 NCI-2012-01096, 2012-0334 Ph 2 recruiting Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome
NCT04488081 I-SPY_COVID I-SPY-COVID Ph 2 active not recruiting I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
NCT03970096 RG1005364 9749, NCI-2019-03188 Ph 2 recruiting Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
NCT06752694 RG1124040 NCI-2024-06524, 20575 Ph 2 recruiting Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia
NCT04304820 results posted 200033 20-H-0033 Ph 2 recruiting Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)
NCT04375631 RG1006914 NCI-2020-02616, RG1006914 Ph 1 recruiting CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
NCT04195633 RG1005742 NCI-2019-07697, 10343 Ph 2 recruiting Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
NCT05600426 TransIT IRB-2020-0438 1UG3HL157564-01A1, 1U24HL157560-01A1 Ph 3 active not recruiting A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)
NCT06837259 C4921008 2024-520126-11-00 Ph 1 completed A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy Adults
NCT06013423 RG1123652 NCI-2023-05598, FHIRB0020219 Ph 2 recruiting Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
NCT07352566 25-43621 Ph 4 not yet recruiting Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
NCT03128034 9595 NCI-2017-00452, 9595 Ph 1, Ph 2 recruiting 211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
NCT04743739 iMN RTX plus CsA Ph 3 terminated Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN
NCT06642909 HS006-MN-01 Ph 2 active not recruiting A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy
NCT05398653 MIL62-CT206 Ph 1, Ph 2 completed A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy
NCT05579769 results posted CNI60 Ph 2 terminated Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
NCT07196449 MRCI MRCI Ph 1 active not recruiting Drug-Drug Interaction of Rifampicin and Cyclosporine on Methotrexate Pharmacokinetics in Healthy Subjects
NCT05399732 HanB-NSAA-lus Ph 2 completed Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia
NCT06892756 DDI2 CLI-06001AA1-06 2024-516475-32-00 Ph 1 completed Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
NCT07138898 25-00380 Ph 2 not yet recruiting Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NCT05862233 MIL62-CT307 Ph 3 active not recruiting A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy
NCT06541678 C3421063 2024-513863-21-00 Ph 1 completed A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults.
NCT06809608 BP45670 2024-517360-37-00 Ph 1 completed A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081
NCT04530487 results posted 2020-0496 NCI-2020-05879, 2020-0496 Ph 2 terminated Donor Stem Cell Transplant After Chemotherapy for the Treatment of Recurrent or Refractory High-Risk Solid Tumors in Pediatric and Adolescent-Young Adults
NCT00974142 results posted PRO09050330 Ph 1, Ph 2 completed Oral Cyclosporine in Chronic Obstructive Pulmonary Disease
NCT03246906 results posted 9816 NCI-2017-01311, 9816 Ph 2 terminated Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
NCT04979884 cyclosporine in COVID-19 Ph 3 completed Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital
NCT03434730 17-616 Ph 2 completed Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation
NCT05057468 17300534 Ph 3 recruiting Second-line Treatment of Primary Autoimmune Hemolytic Anemia
NCT02188264 NCI-2014-01484 NCI-2014-01484, 13-2628 Ph 1 completed Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer
NCT02416388 BIG-1 PHRC-2010-03 Ph 2, Ph 3 recruiting Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR
NCT02867800 AAAQ2350 Ph 1 completed Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease
NCT06424639 LC-001 Ph 4 not yet recruiting Luspatercept Plus CsA vs CsA for the Treatment of Newly Diagnosed Non-Transfusion-Dependent NSAA
NCT06364319 2024PHD002-001 Ph 4 not yet recruiting Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD
NCT03013933 16414 NCI-2016-02062, 16414 Ph 1 completed Brentuximab Vedotin, Cyclosporine, and Verapamil Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT01041508 results posted T2008-005 IND 101588 Ph 1 completed Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.
NCT04515329 STUDY20010206 Ph 4 withdrawn Tear Film Markers in Dry Eye Syndrome
NCT02998645 SOAR results posted CETB115E2403 2016-002814-29 Ph 2 completed Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic Anemia
NCT04555694 results posted TC-2020-DexRes Ph 4 completed Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax
NCT00816413 0164-07-FB P30CA036727 Ph 1, Ph 2 withdrawn Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer
NCT04492891 results posted H-48163 Ph 2 completed Cyclosporine For The Treatment Of COVID-19(+)
NCT00896493 results posted IRB-16213 SU-04062009-2138, 16213 Ph 2 completed Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
NCT05202145 ALXN2050-HV-110 Ph 1 completed Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants
NCT04532918 results posted D5495C00013 Ph 1 completed Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
NCT00796068 results posted 2275.00 NCI-2010-00299, 2275 Ph 2 completed Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematological Cancer Who Are Undergoing Umbilical Cord Blood Transplant
NCT05573230 18506 J2A-MC-GZGL Ph 1 completed A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants
NCT02688556 Emerald results posted OTX-101-2016-001 Ph 3 completed Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Showing 50 of 121 trials

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Active Pipeline

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VEVYE FDA Label Details

Indications & Usage

FDA Label (PDF)

VEVYE is indicated for the treatment of Dry Eye Disease.

View full patent landscape →
6 OB patents · 5 families · 160 international docs across 21 countries

VEVYE Patents & Exclusivity

Latest Patent: Apr 2042
Exclusivity: May 2026

Patents (6 active)

US12059449 Expires Apr 1, 2042
US11413323 Expires Oct 11, 2039
US11154513 Expires Nov 20, 2038
US10813976 Expires Sep 22, 2037
US12496326 Expires Sep 29, 2036
US8614178 Expires Dec 13, 2030

Exclusivity

NP Until May 2026
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
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Patent Timeline

  • • Cliff: 2042
  • • 6 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 5 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA217469 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.