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.
NCT00211445 ↗	Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)	Completed	Manhattan Eye, Ear & Throat Hospital	Phase 2	2002-07-01	Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by exudation of fluid under the retina localized to the posterior pole as well as loss of vision. The etiology is unknown, but according to the studies this condition is more common in young males and is associated with type A personality. Clinically, CSC is characterized by serous retinal detachment and area of leakage of in the subretinal space. The standard of care for acute CSC is observation for a period of up to 3 months. If there is no complete resolution of the retinal detachment by 3 months, there is an indication for focal laser photocoagulation therapy of the area of leakage. This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of detachment. However, laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because there is not a single easily identifiable point of leakage but rather diffuse disease of RPE thus rendering laser treatment ineffective.The purpose of this medical research study is to evaluate Verteporfin therapy as an approach which may benefit patients with CSC, based on observations in exudative type of AMD patients treated with Photodynamic Therapy using Verteporfin.
NCT00345241 ↗	Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points	Completed	University of Texas Southwestern Medical Center	N/A	2006-01-01	To evaluate tear film stability of a market lubricant therapeutic eye drop versus saline when using Evaporometry and Interferometry in patients with a diagnosis of Keratoconjunctivitis Sicca (KCS). The purpose of this research is to evaluate evaporative parameters and tear film quality when using Systane lubricating eye drops versus saline in the eyes of dry eye patients at pre-instillation and at 30 and 60 minutes post instillation of drop(s).
NCT00355459 ↗	A Prospective Clinical Study Assessing the Effects of Tetracycline Antibiotic on Tear Film and Tear Lipid Composition Within a Population of Patients Diagnosed With Blepharitis and Dry Eye Disease	Withdrawn	University of Texas Southwestern Medical Center	N/A	2005-08-01	The purpose of this research project is to determine the effects of oral tetracycline such as Minocycline (Minocin) on tear film composition and tear lipid (meibomian gland secretions) characteristics in patients with chronic Blepharitis and associated dry eyes.
NCT00531024 ↗	Systemic Avastin Therapy in Age-Related Macular Degeneration	Completed	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery	Phase 2/Phase 3	2005-08-01	Choroidal neovascularisation (CNV) in age-related macular degeneration is one of the major causes of blindness in the western world. It is already known that the vascular endothelial growth factor (VEGF) plays a major role in the development of CNV. Photodynamic therapy (PDT), subretinal surgery, and intravitreal injection of VEGF- inhibitors are the common treatments. These methods are either very invasive or need to be repeated several times over long periods of time in order show some effect. Furthermore PDT can only be performed in eyes with pigment epithelium detachments (PED) of maximum 50% of the avascular zone, while intravitreal injections can lead to endophthalmitis and acute glaucoma. A systemic treatment, which would only need to be administered 3 times within 6 weeks would be a major effort in macular degeneration therapy.

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
Keratoconjunctivitis Sicca	2

Condition MeSH

Condition MeSH for FLUORESCEIN SODIUM
Intervention	Trials
Dry Eye Syndromes	14
Keratoconjunctivitis Sicca	10
Eye Diseases	6
Macular Edema	4

Clinical Trial Locations for FLUORESCEIN SODIUM

Trials by Country

Trials by Country for FLUORESCEIN SODIUM
Location	Trials
United States	30
China	4
Canada	3
United Kingdom	1
Korea, Republic of	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 Clinical Trials Update, Market Analysis, and Forecast: Study Activity, Competitive Landscape, and Commercial Trajectory

Last updated: July 28, 2026

Fluorescein sodium is a long-established, off-patent diagnostic dye used for ophthalmic angiography and other visualization indications. Commercial supply is dominated by legacy generic formulations rather than active, patent-linked brand competition. For R&D and investment planning, the practical watchpoints are: (1) FDA and label/indication expansions or refinements for ophthalmic and emergency visualization uses, (2) device-drug combination practice changes (imaging systems and protocols), and (3) manufacturing continuity for sterile injectables and solution stability.

Because fluorescein sodium is widely available as generic or repackaged products, near-term market dynamics track procedure volumes and payer reimbursement patterns more than patent-driven launches. A defensible forecast is therefore built on utilization growth, inventory/reliability economics, and mix shift toward higher acuity retinal diagnostics rather than on new-entrant MOA innovation.

What clinical trials exist for fluorescein sodium in 2024–2026, and what do they test?

Featured snippet: Most recent activity is protocol and imaging-procedure focused, not mechanism innovation. Trial themes cluster around ophthalmic angiography workflows, dosing/administration practicality, and safety/quality in specific patient populations.

Public clinical trial activity for fluorescein sodium tends to be interventional only in limited pockets (single-center optimization, safety/PK assessments in constrained populations, or comparative imaging protocol studies). The bulk of clinical evidence is historical, with modern studies often serving comparative diagnostic endpoints rather than new therapeutic concepts.

Trial types commonly seen for fluorescein sodium

• Ophthalmic angiography imaging protocol comparisons: Compare visualization quality and adverse event rates across administration technique, imaging timing, and camera/imaging system settings.
• Dosing practicality and repeatability: Assess feasibility for same-day repeat imaging or modified dosing under specific clinical constraints.
• Safety and tolerability in special populations: Renal impairment, allergy history, pediatric cohorts, and comorbidity stratification.
• Diagnostic accuracy comparisons: Evaluate fluorescein angiography performance against OCT-A, widefield imaging, or alternative dyes/imaging pathways.

Key endpoints used in fluorescein trials

• Visualization quality scores (retinal vessel delineation, choroidal penetration clarity)
• Time-to-peak fluorescence and time-to-clearance
• Incidence and severity of adverse events (including nausea, hypersensitivity reactions)
• Diagnostic agreement metrics (sensitivity/specificity or concordance with reference standards)
• Patient tolerability and workflow metrics (procedure duration, imaging success rate)

How to interpret “trial updates” for fluorescein sodium

If a trial is registered, it typically does not imply a new commercially protected product. For fluorescein sodium, trial updates usually translate into:

• incremental label refinement (administration technique, contraindication language, or timing),
• procedure-standardization adoption by retina and emergency teams,
• and manufacturing quality or sterility assurance improvements that reduce supply risk.

How big is the fluorescein sodium market today by use-case, and what drives growth?

Featured snippet: Growth tracks retinal disease diagnosis and procedural volume, while sales are buffered by generic availability and supply stability.

Demand drivers

1. Retinal disease incidence and detection intensity
   • Increased screening and diagnostic workups drive fluorescein angiography usage.
2. Emergency and diagnostic visualization protocols
   • Uses outside ophthalmology can add volume, but the market remains relatively concentrated in eye care.
3. Workflow adoption and imaging technology diffusion
   • Wider use of camera systems and standardized angiography protocols supports steady dye demand.
4. Generic purchasing and hospital formulary behavior
   • Procurement is cost-optimized; price compression can offset volume growth.

Supply and pricing mechanics

• Fluorescein sodium is mature and generic, so average selling prices are shaped by tendering cycles, sterile manufacturing capacity, and quality reliability.
• Sales growth is therefore “volume minus price,” with price pressure the main drag in highly competitive generic channels.

Market sizing approach for forecasting (practical)

A robust projection can be built from:

• procedure volume proxies (retina clinics and imaging throughput),
• utilization per procedure (dose vial size and number of imaging cycles),
• and generic ASP trends by country.

Because fluorescein sodium is off-patent, forecasting must treat it as an operations and utilization product, not a patent-based launch product.

When does fluorescein sodium lose exclusivity, and are there any meaningful patent barriers?

Featured snippet: There is no active, broadly controlling patent exclusivity for the core dye molecule; competitive barriers are manufacturing quality, regulatory approvals, and label-specific wording rather than fundamental patent protection.

Fluorescein sodium is a known substance with widespread generic access. For the commercial outlook, the relevant “exclusivity” is regulatory and label alignment:

• whether a product is positioned for specific approved indications,
• and whether formulation or container-closure specifications create procurement preference.

What typically remains “protectable” after molecule off-patent status

• manufacturing process know-how (sterile filtration, stability, container compatibility),
• packaging, concentration, and presentation formats,
• and (occasionally) narrow method-of-use language in labeling driven by clinical evidence.

For investors and licensees, the risk profile is that new entrants can usually replicate the drug substance and standard formulations if regulatory pathways are available and quality systems are adequate.

What patents protect fluorescein sodium formulations, methods of use, or imaging protocols?

Featured snippet: The patent estate is not likely to provide durable exclusivity for the core dye; any actionable protection usually sits in narrow formulation presentations, method-of-use constructs tied to labeled imaging, or specific manufacturing steps.

Without a specific, current Orange Book and patent-family pull for named marketed products in each jurisdiction, the only reliable strategy is to treat patents as narrow and product-specific. The actionable diligence work for any new entrant or license depends on:

• which exact marketed strengths and presentations are relevant,
• which jurisdictions matter (US, EU, UK, Canada, major tenders),
• and whether any product has non-obvious formulation/process IP that would block generic substitution.

In fluorescein sodium, most competitive entry obstacles are regulatory and manufacturing rather than molecule coverage.

What is the Orange Book status of fluorescein sodium products?

Featured snippet: Multiple generic and branded entries exist historically; for most planning purposes, the molecule is not under long-term US patent exclusivity.

Orange Book status must be checked by exact NDC/product. Planning-level conclusions:

• If a product is on the Orange Book, it may list patents tied to formulation, use, or manufacturing.
• In a mature off-patent compound, those patents are usually not the gating factor for generics once expired or non-listed.

For business decisions, treat Orange Book status as a product selection constraint, not a determinant of market entry timing for the molecule itself.

What Paragraph IV challenges exist for fluorescein sodium?

Featured snippet: Paragraph IV litigation is uncommon for mature generic dyes where patents are limited or expired.

In mature, off-patent categories, Paragraph IV challenges are often absent or sporadic because:

• there is little enforceable patent coverage to challenge,
• or the market is already fully generic with numerous equivalent approvals.

A litigation-driven inflection is therefore not a primary driver of fluorescein sodium market timing.

How does fluorescein sodium compare with alternatives (ICG, other dyes, and imaging without dyes)?

Featured snippet: Fluorescein sodium remains a workhorse for retinal vascular visualization; alternatives shift use by indication, depth penetration, allergy profile, and clinician workflow.

Competitive set

• Indocyanine green (ICG): Often used for choroidal imaging and leakage patterns where fluorescein is less informative.
• Non-dye imaging (OCT-A, other modalities): Reduces dye reliance in some pathways but does not eliminate fluorescein use for angiographic leakage and vessel delineation.
• Other contrast agents: Used in niche diagnostic protocols.

How substitution affects demand

• Substitution reduces dye volume only if alternative workflows become standard-of-care for specific disease phenotypes.
• In practice, fluorescein sodium maintains demand because many diagnostic pathways still require fluorescein angiography for definitive leakage mapping.

What market projection scenarios are most realistic for fluorescein sodium through 2029?

Featured snippet: Base case is low-single-digit volume growth offset by generic price compression; upside is retina diagnostic expansion and supply-normalization; downside is pricing pressure or supply disruptions.

Base case (most likely)

• Volume: modest growth tied to retinal disease screening and procedural throughput.
• Price: downward pressure from generic competition and tendering.
• Net sales: low-to-mid single-digit growth depending on geography mix.

Upside case

• Wider adoption of imaging protocols that require repeat imaging per patient.
• Improved capacity leading to fewer stock-outs and stronger contract fulfillment.
• Reimbursement improvements for diagnostic angiography.

Downside case

• Stronger price compression and margin erosion.
• Supply disruptions at sterile injectable manufacturers.
• Label or guideline changes that reduce fluorescein use in specific sub-indications.

What risks could change the forecast (regulatory, safety, and supply)?

Featured snippet: The dominant risks are sterile supply reliability, adverse-event labeling, and procurement-driven price compression, not blockbuster-type regulatory events.

Safety and labeling risk

• Hypersensitivity reactions and nausea are well-characterized. Any updated safety communication can shift usage patterns and procurement preferences.
• For products in crowded generic markets, stronger adverse event signals can change hospital formulary behavior even without a broad regulatory withdrawal.

Supply-chain risk

• Sterile manufacturing constraints, raw material availability, and quality events create forecast volatility.
• Even small supply disruptions can cause temporary demand reallocation and price swings in tender markets.

Regulatory and quality risk

• Post-approval quality issues can delay shipments and reduce contract share.

How strong is the competitive landscape, and what strategy fits generic vs. differentiated products?

Featured snippet: Differentiation is likely to be operational (reliability, presentation, shelf life), not therapeutic.

Market structure

• Numerous generic suppliers compete on price and supply reliability.
• Hospitals optimize for cost plus delivery consistency and product availability at time of need.

Winning strategies

• Consistent supply and short lead times to hospitals and group purchasing organizations.
• Presentation choices that reduce dosing waste or ease administration workflow.
• Quality system strength and fewer lot rejections.

Key Takeaways

• Fluorescein sodium demand tracks ophthalmic diagnostic procedure volume, especially retinal angiography, and is buffered by entrenched clinical use.
• Trial activity in recent years is more likely protocol and workflow optimization than new, patent-protected therapeutic innovation.
• Exclusivity is not a core driver. Commercial outcomes hinge on generic competition, pricing pressure, and sterile manufacturing reliability.
• Forecasts through 2029 should be built on procedure volumes and “volume minus price,” with upside tied to expanded diagnostics adoption and normalization of supply.

FAQs

1. Are fluorescein sodium clinical trials focused on new dosing regimens or new indications?
2. Do fluorescein sodium generic products differ in safety or efficacy in ophthalmic angiography?
3. How do indocyanine green and OCT-A reduce fluorescein sodium usage in retinal practice?
4. What supply-chain events most commonly disrupt fluorescein sodium availability?
5. How should investors evaluate margin risk for mature, generic diagnostic dyes like fluorescein sodium?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. ClinicalTrials.gov. Fluorescein Sodium studies (database query results). NIH/NLM.
3. PubMed/peer-reviewed reviews on fluorescein angiography and clinical imaging protocols.