Organization (Industry)
LABORATOIRES THEA
ClinicalTrials.gov lists LABORATOIRES THEA as lead sponsor of 64 trials. It has 67 active development programs and 17 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 4 registered with a 2026 start date. The dashed outline is the pace from the 3 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 4.2 trial starts a year over the five years to September, under the 5 a year the method needs. 1 trial is registered to start in 2027 or later.
This page covers LABORATOIRES THEA: 64 lead-sponsored trials and 1 legal-entity registration. The parent company on record for LABORATOIRES THEA is THEA HOLDING, which does not have its own page on this site.
Disease areas (32)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Dry Eye Syndromes | 14 |
| Glaucoma | 11 |
| Blindness | 7 |
| Vision Disorders | 7 |
| Eye Abnormalities | 6 |
Showing 5 of 32 disease areas.
Trials by start year as sponsor or collaborator (23)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 1 trial is registered to start in 2027 or later, and not listed here.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 4 |
| 2025 | 5 |
| 2024 | 3 |
| 2023 | 4 |
| 2022 | 4 |
| 2021 | 6 |
| 2020 | 4 |
| 2019 | 4 |
| 2018 | 3 |
| 2017 | 2 |
Showing 10 of 23 years.
Prediction, not a registry value: median of 30 months from start to primary completion across 5 trials still running at the 2026-10-09 snapshot; registered median of 11 months across 43 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (67)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| sepofarsen | Mitochondrial Diseases | Phase 3 | 1 |
| sepofarsen | Eye Abnormalities | Phase 3 | 1 |
| sepofarsen | Blindness | Phase 3 | 1 |
| sepofarsen | Vision Disorders | Phase 3 | 1 |
| sepofarsen | Optic Atrophy, Hereditary, Leber | Phase 3 | 1 |
Showing 5 of 67 active programs.
Approved assets (17)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Co-Latanoprost | 3 |
| Geltim LP 1 mg/g | 1 |
| Lumigan 0.03% Unit Dose | 1 |
| N-acetyl-aspartyl-glutamate (NAAXIA Sine) | 1 |
| LUMIGAN® (bimatoprost ophthalmic solution) 0.01% | 1 |
Showing 5 of 17 approved assets.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 70% hit target (n=23) | 54% on time (n=24) |
Journals published in (37)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Investigative ophthalmology & visual science | 12 |
| Archives of ophthalmology (Chicago, Ill. : 1960) | 5 |
| Experimental eye research | 3 |
| Nature medicine | 3 |
| Ophthalmology | 3 |
Showing 5 of 37 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 22 | 2 | 2024-09-03 |
FDA warning letters (1)
| Issue date | Letter |
|---|---|
| 2025-07-09 | thea-pharma-inc-712416-07092025 |
FDA recalls (3)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11 | Class II | 2026-04-23 |
| Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11 | Class II | 2026-04-23 |
| Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15 | Class II | 2024-03-05 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Laboratoires Thea | Clermont-Ferrand, FR | EMA, Health Canada |
Organization relationships (1)
| Related organization | Relationship | Evidence |
|---|---|---|
| Sepul Bio | Co sponsors trial with | 8 |
Latest dated events (97)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2027-01 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-10-05 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-04-23 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-04-23 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-03-24 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 97 events.
Biomarker capability evidence (36)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| AATF | Trial sponsor | Named in trial inclusion criteria |
| CEP290 | Trial sponsor | Named in trial inclusion criteria |
| CEP290 | Trial sponsor | Named in trial inclusion criteria |
| ERG | Trial sponsor | Named in trial inclusion criteria |
| KCNH2 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 36 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda untitled letters, fda inspection record, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.