CLINICAL TRIALS PROFILE FOR FLUORESCEIN SODIUM

505(b)(2) Clinical Trials for FLUORESCEIN SODIUM

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00610480 ↗	Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops	Completed	Investigator initiated study	N/A	2007-11-01	The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.
OTC	NCT00610480 ↗	Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops	Completed	University of Texas Southwestern Medical Center	N/A	2007-11-01	The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.

All Clinical Trials for FLUORESCEIN SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000115 ↗	Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema	Completed	National Eye Institute (NEI)	Phase 2	1990-12-01	To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00001863 ↗	Leflunomide to Treat Uveitis	Completed	National Eye Institute (NEI)	Phase 2	1999-03-01	This study will investigate the safety and effectiveness of the drug Leflunomide to treat uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide suppresses immune system activity and has been shown to control autoimmune diseases, such as arthritis (joint inflammation), in animals. It has also improved symptoms in patients with rheumatoid arthritis, and the Food and Drug Administration has approved it for treating patients with this disease. Eye and joint inflammation may have similar causes, and medicines for arthritis often help patients with eye inflammation. This study will examine whether Leflunomide can help patients with uveitis. Patients with uveitis who are not responding well to steroid treatment and patients who have side effects from other medicines used to treat uveitis (such as cyclosporine, cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible side effects of these medicines may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood test and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina) with an ophthalmoscope and the front of the eye with a microscope. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is injected into the bloodstream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. Study participants will be divided into two groups. One group will take 100 milligrams of Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other group will take a placebo-a pill that looks like the Leflunomide pill but does not contain the medicine. All patients in both groups will also take prednisone. Patients will have follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine. Those who do well and want to continue their assigned treatment after 6 months can continue that treatment for another 6 months and will have follow-up exams at months 9 and 12.
NCT00008515 ↗	Fluocinolone Implant to Treat Macular Degeneration	Completed	National Eye Institute (NEI)	Phase 1	2001-01-01	This study will test the safety and effectiveness of a fluocinolone implant to treat age-related macular degeneration. This eye disease can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. It is the leading cause of vision loss in people over age 60. The fluocinolone implant is a tiny plastic rod with a pellet of the steroid fluocinolone on the end. The pellet slowly dissolves and releases the medication into the fluid in the eye. Vision loss in macular degeneration is caused by the formation of new blood vessels in the choroid-a thin, pigmented vascular layer of the eye behind the retina. These abnormal vessels leak blood under the macula, the part of the retina that determines central vision. Tissue studies show evidence of inflammation in the retinas of patients. This study will test whether the slow release of the steroid fluocinolone directly into the affected part of the eye can prevent or slow further vision loss. Preliminary animal and human studies with fluocinolone implants have shown some benefit in reducing blood vessel growth and improving or stabilizing vision. Patients 50 years of age and older with age-related macular degeneration may be eligible for this study. Study patients will be randomly assigned to one of two treatment groups. One will receive a 0.5-mg dose implant; the other will receive a 2-mg dose implant. Theoretically, the implants can release the medicine for 2 to 3 years. Participants will have a medical history, physical examination and complete eye examination. The latter will include a vision test, eye pressure measurement, examination of the pupils, lens, retina, and eye movements. Photographs of the eye will be taken with a special camera. Patients will also undergo fluorescein angiography, a test that takes pictures of the retina using a yellow dye called sodium fluorescein. The dye is injected into the blood stream through a vein. After it reaches the blood vessels of the eye, photographs are taken of the retina. When the above tests are completed, patients will be scheduled for surgery to place the implant. The procedure will be done under either local or general anesthesia. Follow-up visits will be scheduled 1, 2, 4, and 6 weeks after surgery, then at 3 and 6 months after surgery, and then every 6 months until the implant is depleted of medicine or is removed. Several of the exams described above will be repeated during the follow-up period to evaluate the treatment and side effects, if any.

Clinical Trial Conditions for FLUORESCEIN SODIUM

Condition Name

Condition Name for FLUORESCEIN SODIUM
Intervention	Trials
Dry Eye	5
Dry Eye Disease	4
Macular Degeneration	3

Condition MeSH

Condition MeSH for FLUORESCEIN SODIUM
Intervention	Trials
Dry Eye Syndromes	14
Keratoconjunctivitis Sicca	10
Eye Diseases	6

Clinical Trial Locations for FLUORESCEIN SODIUM

Trials by Country

Trials by Country for FLUORESCEIN SODIUM
Location	Trials
United States	30
China	4
Canada	3
Indonesia	1
Austria	1

Trials by US State

Trials by US State for FLUORESCEIN SODIUM
Location	Trials
New York	7
Texas	4
Massachusetts	3
Florida	3
California	3

Clinical Trial Progress for FLUORESCEIN SODIUM

Clinical Trial Phase

Clinical Trial Phase for FLUORESCEIN SODIUM
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	2

Clinical Trial Status

Clinical Trial Status for FLUORESCEIN SODIUM
Clinical Trial Phase	Trials
Completed	25
Unknown status	9
Recruiting	6

Clinical Trial Sponsors for FLUORESCEIN SODIUM

Sponsor Name

Sponsor Name for FLUORESCEIN SODIUM
Sponsor	Trials
National Eye Institute (NEI)	3
University of Texas Southwestern Medical Center	3
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for FLUORESCEIN SODIUM
Sponsor	Trials
Other	58
Industry	9
NIH	8

FLUORESCEIN SODIUM Market Analysis and Financial Projection

Last updated: April 27, 2026

Fluorescein Sodium: Clinical Trial Update, Market Analysis, and Forecast

What is fluorescein sodium and how is it used clinically?

Fluorescein sodium is a fluorescent dye used to visualize tissue and vascular structures during ophthalmic procedures and in diagnostic imaging in multiple clinical settings. Commercially, the drug is typically offered as an injectable solution and is integrated into standard-of-care workflows for eye disease assessment and surgical guidance.

Key marketed use areas

• Ophthalmology: fundus angiography, fluorescein angiography during evaluation of retinal and choroidal vascular disorders.
• Neurology and imaging pathways (where authorized): diagnostic fluorescence-based imaging protocols used in clinical practice.
• Surgery and wound/vascular visualization (where authorized): use in selected guidance workflows.

Regulatory status (global) Fluorescein sodium is a long-established active ingredient; the current landscape is dominated by generic manufacturers and formulation/labeling differences rather than brand-new molecular entities.

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What does the clinical trials pipeline look like now?

A complete, current, trial-level update requires an authoritative trial registry pull (for example, ClinicalTrials.gov and regional registries) mapped to active recruiting, not-yet-recruiting, or ongoing observational studies, then filtered to interventional or diagnostic intent for fluorescein sodium.

No such trial registry dataset is provided here, and no reliable, present-tense trial counts, phases, timelines, or endpoints can be produced from the information available in this chat.

Clinical trials summary (based on unavailable inputs)

• No defensible, up-to-date trial list, phase breakdown, enrollment status, or endpoint review can be stated without registry data.

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What is the market size and who buys fluorescein sodium?

A defensible market size and unit economics forecast also requires current market research inputs (e.g., IQVIA, EvaluatePharma, GlobalData, or equivalent), plus public purchasing or reimbursement data by geography and product form.

No market research dataset is provided here, so the only hard, actionable analysis that can be stated is structural: how demand forms and why pricing behaves as it does for long-established dyes.

Demand drivers

• Procedural frequency: retina imaging volume and ophthalmic diagnostic throughput drive usage.
• Diagnostic substitution limits: fluorescence angiography has workflow inertia because it is integrated into imaging protocols.
• Generic competition: patent life is not the principal pricing determinant for a long-established dye; supply and formulation availability tend to drive cost.

Buyer categories

• Hospital systems (ophthalmology departments, emergency and stroke/diagnostics, imaging centers).
• Eye clinics and ambulatory surgical centers running angiography protocols.
• Imaging service networks that standardize dye supply for diagnostic consistency.

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How will pricing and competition likely evolve?

In a legacy diagnostic dye market, commercial dynamics usually follow:

• Generic price pressure: multiple suppliers reduce pricing power.
• Tendering and formulary controls: government and payer procurement processes dominate outcomes.
• Regulatory and labeling variation: differences in indicated use can affect substitution rates more than chemistry changes.

What typically matters to buyers

• Availability and lot consistency.
• Formulation stability and shelf life.
• Distribution reliability (especially for infusion-ready presentations).
• Compatibility with imaging workflows.

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What is the forecast for adoption and volume growth?

Forecasting requires baseline utilization, procedure epidemiology (e.g., retinal disease burden), country-by-country procedure volumes, and supply-side capacity. Those inputs are not available here, so no numerically anchored adoption curve can be produced without fabricating numbers.

What can be said structurally

• Growth tracks ophthalmic diagnostic demand and expansion of outpatient imaging capacity.
• Substitution is limited where fluorescence-based imaging remains a preferred standard.
• Volume tends to be resilient relative to discretionary spend, since dyes are consumables within required diagnostic steps.

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What regulatory and lifecycle factors affect fluorescein sodium?

For established actives like fluorescein sodium, lifecycle impacts usually come from:

• Labeling expansions or restrictions tied to updated safety and imaging evidence.
• Manufacturing compliance affecting supply continuity.
• Formulation and presentation (concentration, packaging, sterile preparation standards).
• Country-specific authorization for different clinical uses.

Without a specific product list (by manufacturer, strength, package type, and regulatory label), no precise lifecycle-event timeline can be produced here.

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Investment and R&D implications

Because fluorescein sodium is a legacy fluorescent dye, the highest-probability commercial pathways are:

• Product-line execution: secure supply, reduce COGS, and maintain regulatory compliance.
• Formulation differentiation: improve stability, handling, and compatibility with imaging workflows.
• Regulatory strategy: align with standardized procedural indications and payer-approved imaging pathways.

No actionable R&D roadmap can be specified for “fluorescein sodium” specifically without knowing whether the objective is:

• new molecular entity development,
• new delivery/formulation,
• new indication trials,
• or device-dye co-development.

Those objectives determine trial design, regulatory route, and expected timelines, but no objective is specified in the prompt.

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Key Takeaways

• Fluorescein sodium demand is driven primarily by ophthalmic diagnostic procedures and established imaging workflows, with market competition shaped more by generic supply and procurement than by molecule-level patent exclusivity.
• No defensible current clinical trial update, pipeline phase counts, active recruitment status, or endpoint-level readout can be produced without registry data.
• No defensible market size and numeric forecast can be produced without current market research and procedure utilization baselines.
• Commercial outcomes typically track procedural throughput, availability, tendering dynamics, and formulation reliability rather than transformative R&D.

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FAQs

1) Is fluorescein sodium still being studied in new clinical trials?
Clinical trial activity exists across diagnostic and imaging workflows, but a present-tense update (phases, recruiting status, endpoints) requires trial registry data not included here.

2) What drives the market for fluorescein sodium most strongly?
Imaging and angiography procedure volumes, especially in ophthalmology, and procurement through hospital formularies and tendering.

3) Does patent protection materially shape pricing for fluorescein sodium?
Typically not in the way it does for newer drugs. Pricing is more often governed by generic competition, manufacturing supply, and procurement controls.

4) What product attributes influence hospital purchasing decisions?
Availability, sterile handling readiness, lot consistency, stability/shelf life, packaging, and compatibility with imaging workflows.

5) What is the most realistic growth lever for a company in this space?
Securing supply reliability at competitive cost and aligning regulatory labeling and formulation presentation to standardized clinical pathways.

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References (APA)

[1] ClinicalTrials.gov. (n.d.). Fluorescein sodium. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approvals and labels (search: fluorescein sodium). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] European Medicines Agency. (n.d.). Medicines (search: fluorescein sodium). https://www.ema.europa.eu/