Last reviewed · How we verify
Fluorescite (FLUORESCEIN)
Fluorescein, marketed as Fluorescite by Novartis, is a well-established drug used for fluorescein staining of the eye, with a key composition patent expiring in 2028. Its primary competitive advantage lies in its mechanism of action, which involves binding to Cytochrome P450 2C19 to effectively visualize the eye's structures during staining. The primary risk is competition from same-class drugs like rose bengal, whose patent status is unknown, potentially impacting market share.
At a glance
| Generic name | FLUORESCEIN |
|---|---|
| Sponsor | Novartis |
| Drug class | Diagnostic Dye |
| Target | Cytochrome P450 2C19 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2020 |
Approved indications
- Fluorescein staining of eye
Common side effects
- Skin discoloration
- Urine discoloration
- Nausea
- Vomiting
- Gastrointestinal distress
- Strong taste
- Headache
Serious adverse events
- Anaphylaxis
- Bronchospasm
- Generalized hives and itching
- Syncope
- Hypotension
- Cardiac arrest
- Basilar artery ischemia
- Severe shock
- Death
- Convulsions
Key clinical trials
- A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer (NA)
- Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction (PHASE4)
- Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer (PHASE2)
- Automated Applanation Tonometry - Updated (NA)
- Retinal Vessel Leakage in Cerebral Small Vessel Disease
- Neoadjuvant Tebentafusp for Uveal Melanoma (PHASE2)
- Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children (NA)
- Intraoperative Use of I.V. Sodium Fluorescein in Suspected CNS Tumors
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fluorescite CI brief — competitive landscape report
- Fluorescite updates RSS · CI watch RSS
- Novartis portfolio CI