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Disease

Dry Eye Syndromes

Late-stage therapeutic developmentEmerging research
MeSHDry Eye Syndromes
1
Publications
15
Clinical trials
2017
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

TFOS DEWS II Report Executive Summary.

Research2017-08-08The ocular surface

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 1 regulatory approval from EMA on record.
  • 2 clinical trials expected to report results, the earliest in Q4 2026.
Upcoming Milestones
Major developments
Upcoming trial readoutImportant
Clinical Study of Mesenchymal Stem Cell Eye Drops for Treating Dry Eye Disease
Results expected Q3 20282026-04-15
Important regulatory approvalImportant
Approval — Pegfilgrastim
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).2025-08-18
Upcoming trial readoutImportant
The Protective Impact of TheaLoz Duo Eyedrop on the Ocular Surface in Hand-Held Console and Computer Game Users
Results expected Q4 20262026-01-21
Clinical Milestones3View
Results expected 2
Recently completed 1
Regulatory Updates1View
  • 2025-08-18Approval — PegfilgrastimReduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Activity timeline4

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Imetelstatapproved

Approval — Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk mye… (2025)

Pegfilgrastimapproved

Approval — Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adul… (2025)

Azacitidineapproved

Approval — Azacitidine Kabi is indicated for the treatment of adult patients who are not eligible fo… (2024)

Efbemalenograstim alfaapproved

Approval — Ryzneuta is indicated for the reduction in the duration of neutropenia and the incidence… (2024)

Lenalidomideapproved

Approval — Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatme… (2021)

Luspaterceptapproved

Approval — Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to… (2020)

Clinical trials

14 sponsors · 0 new · 0 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
15
All trials
3
Active
9
Late-stage
6
Completed
Late-stage studies

A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome

Phase 3 · Completed · Huons Co., Ltd.

A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Phase 3 · Completed · Mimetogen Pharmaceuticals USA, Inc.

Comparative Efficacy of Different Treatment Regimens in Patients With Dry Eye Disease and Meibomian Gland Dysfunction

Phase 4 · Completed · Tauber Eye Center

Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction - Comparison to Oral Treatment With Doxycycline

Phase 4 · Completed · Medical University of Vienna

Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study

Phase 4 · Completed · University of Florida

Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level

Phase 3 · Completed · University of Faisalabad
Recently completed

A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome

Phase 3 · Completed · Huons Co., Ltd.

A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Phase 3 · Completed · Mimetogen Pharmaceuticals USA, Inc.

Comparative Efficacy of Different Treatment Regimens in Patients With Dry Eye Disease and Meibomian Gland Dysfunction

Phase 4 · Completed · Tauber Eye Center

Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction - Comparison to Oral Treatment With Doxycycline

Phase 4 · Completed · Medical University of Vienna

Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study

Phase 4 · Completed · University of Florida

Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level

Phase 3 · Completed · University of Faisalabad

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2025emaApproval — Pegfilgrastim· Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). source ↗
2025emaApproval — Pegfilgrastim· Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). source ↗
2025emaApproval — Imetelstat· Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). source ↗
2024emaApproval — Efbemalenograstim alfa· Ryzneuta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). source ↗
2024emaApproval — Azacitidine· Azacitidine Kabi is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation(HSCT) with: Intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the international prognostic scoring system (IPSS), Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30% marrow blasts according to the WHO classification. source ↗
2021emaApproval — Lenalidomide· Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). source ↗
2020emaApproval — Pegfilgrastim· Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). source ↗
2020emaApproval — Luspatercept· Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia.  Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia.  source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

1 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Most influential

TFOS DEWS II Report Executive Summary.

The ocular surface · 2017 · 552 cites
Recent publications

TFOS DEWS II Report Executive Summary.

The ocular surface · 2017 · 552 cites
Major themes1
  • Dry Eye Syndromes1
Leading journals1
  • The ocular surface1
Leading researchers8
  • Azar DT1
  • Belmonte C1
  • Bron AJ1
  • Chauhan SK1
  • Craig JP1
  • de Paiva CS1
  • Gomes JAP1
  • Hammitt KM1
Affiliations (unnormalised)6
  • Baylor College of Medicine1
  • Centre for Contact Lens Research1
  • Federal University of Sao Paulo/Paulista School of Medicine1
  • HealthPartners Medical Group and Clinics1
  • Instituto de Neurociencias de Alicante1
  • New Zealand National Eye Centre1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Corneal and conjunctival dryness due to deficient tear production, predominantly in menopausal and post-menopausal women. Filamentary keratitis or erosion of the conjunctival and corneal epithelium may be caused by these disorders. Sensation of the presence of a foreign body in the eye and burning of the eyes may occur.

Identifiers
MeSHDry Eye Syndromes
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.