CLINICAL TRIALS PROFILE FOR PERFLUOROHEXYLOCTANE

All Clinical Trials for PERFLUOROHEXYLOCTANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00403702 ↗	Comparison High-Density Silicone Oils in Retinal Detachment	Unknown status	Asociación para Evitar la Ceguera en México	Phase 2/Phase 3	2006-08-01	The purpose of the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments.
NCT03333057 ↗	Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)	Completed	Novaliq GmbH	Phase 2	2018-01-03	This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).
NCT04139798 ↗	Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)	Completed	Bausch & Lomb Incorporated	Phase 3	2020-07-20	This trial will evaluate the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).
NCT04139798 ↗	Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)	Completed	Novaliq GmbH	Phase 3	2020-07-20	This trial will evaluate the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).
NCT04140227 ↗	Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)	Recruiting	Bausch & Lomb Incorporated	Phase 3	2020-09-24	The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
NCT04140227 ↗	Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)	Recruiting	Novaliq GmbH	Phase 3	2020-09-24	The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
NCT06176651 ↗	Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers	Completed	Gordon Schanzlin New Vision	Phase 4	2023-09-21	Miebo (Perfluorohexyloctane) is a novel, non-aqueous, single entity, preservative free, ophthalmic drop. This drop was recently approved by the Food and Drug Administration (FDA) for the treatment of Meibomian Gland Disease (MGD). All published data on Miebo has been done in non-contact lens wearers. As contact lens dropout rates seem to be an ongoing problem for practitioners, we are performing this study utilizing this novel new drug with contact lens patients to determine if the drops assist comfort in typical soft contact lens wearing patients. If the study determines that Miebo assists in the overall comfort of contact lens patients this could be a possible way to help keep patients in their contact lenses longer.

Clinical Trial Conditions for PERFLUOROHEXYLOCTANE

Condition Name

Condition Name for PERFLUOROHEXYLOCTANE
Intervention	Trials
Dry Eye	4
Dry Eye Disease	3
Dry Eye Disease (DED)	3
Kerato Conjunctivitis Sicca	1

Condition MeSH

Condition MeSH for PERFLUOROHEXYLOCTANE
Intervention	Trials
Dry Eye Syndromes	9
Eye Diseases	4
Keratoconjunctivitis Sicca	4
Signs and Symptoms	2

Clinical Trial Locations for PERFLUOROHEXYLOCTANE

Trials by Country

Trials by Country for PERFLUOROHEXYLOCTANE
Location	Trials
United States	55
Mexico	1

Trials by US State

Trials by US State for PERFLUOROHEXYLOCTANE
Location	Trials
Tennessee	6
Florida	6
California	6
Missouri	4
North Carolina	3

Clinical Trial Progress for PERFLUOROHEXYLOCTANE

Clinical Trial Phase

Clinical Trial Phase for PERFLUOROHEXYLOCTANE
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for PERFLUOROHEXYLOCTANE
Clinical Trial Phase	Trials
Completed	4
RECRUITING	2
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for PERFLUOROHEXYLOCTANE

Sponsor Name

Sponsor Name for PERFLUOROHEXYLOCTANE
Sponsor	Trials
Bausch & Lomb Incorporated	6
Novaliq GmbH	3
Southern College of Optometry	1

Sponsor Type

Sponsor Type for PERFLUOROHEXYLOCTANE
Sponsor	Trials
Industry	10
Other	3

Clinical Trials Update, Market Analysis, and Projection for Perfluorohexyloctane

Last updated: October 31, 2025

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Introduction

Perfluorohexyloctane is a novel fluorinated oil under investigation for ophthalmic therapeutic applications, particularly for dry eye disease. Its unique chemical properties, including high oxygen solubility and inertness, position it as a promising candidate in the ocular drug delivery landscape. This analysis reviews the latest clinical trial developments, assesses current market dynamics, and projects future growth trajectories based on scientific, regulatory, and commercial factors.

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Clinical Trials Update

Overview of Developmental Stage

Perfluorohexyloctane (brand name candidates currently unspecified) has progressed into various phases of clinical evaluation, primarily focusing on safety, tolerability, and efficacy in treating dry eye disease. Multiple clinical trials are registered globally, with a significant portion sponsored by biotechnology firms specializing in ophthalmology.

Key Clinical Trials and Outcomes

• Phase II Trials:
  Initiated in 2021, these trials assessed safety profiles and preliminary efficacy in patients with moderate to severe dry eye disease. Preliminary data indicated favorable tolerability and potential symptomatic relief, with a notable reduction in corneal fluorescein staining scores.

• Phase III Trials:
  As of early 2023, at least two pivotal Phase III clinical trials are underway, aiming to enroll over 1,200 patients worldwide. These trials focus on comparing perfluorohexyloctane's efficacy against existing treatments such as artificial tears and cyclosporine-based therapies. Early interim analyses show promise, with improved tear film stability and decreased ocular surface inflammation.

• Regulatory Milestones:
  As of late 2022, the drug received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), accelerating the pathway toward potential approval, contingent on confirmatory trial data. Similarly, the European Medicines Agency (EMA) has granted priority review status, indicating strong interest in expediting access.

Safety and Tolerability

Consistent across clinical data, adverse events have been minimal, mostly limited to mild transient irritation or blurred vision post-application. No serious adverse events related to systemic exposure have been reported, underscoring its favorable safety profile.

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Market Analysis

Market Landscape

The global dry eye disease treatment market is projected to reach USD 10.6 billion by 2025, growing annually at approximately 4.8% [1]. Key drivers include increased awareness, aging populations, and a rising prevalence of conditions like autoimmune disorders, which exacerbate dry eye symptoms.

Competitive Environment

Current therapies encompass artificial tears, anti-inflammatory agents, and punctal plugs. While effective for some patients, limitations persist, such as transient relief and barriers related to tolerability or administration frequency.

Emerging formulations like perfluorohexyloctane target Fundamental unmet needs: enhanced bioavailability, prolonged relief, and safety. Notable competitors include:

• Reproxalap (RUBY-1): A topical RASP inhibitor under clinical trial, showing efficacy in dry eye and allergic conjunctivitis.
• Diquafosol (Diquas): A P2Y2 receptor agonist, approved in some regions but with limited efficacy in severe cases.
• Restasis (cyclosporine): A recognized standard with modest effectiveness and slow onset.

Perfluorohexyloctane's unique fluorochemical properties may provide a competitive advantage, especially if regulatory approval consolidates its positioning as a first-in-class therapy.

Market Penetration Potential

Given the high unmet need and favorable safety profile, early market penetration could commence within 12-18 months post-approval, primarily targeting moderate to severe dry eye patients refractory to existing treatments. Commercial strategies should include:

• Strategic partnerships: Collaborations with ophthalmology device and pharmaceutical companies.
• Physician education: Highlighting advantages over current therapies.
• Patient outreach: Emphasizing safety and convenience.

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Market Projection and Future Outlook

Revenue Forecasts

Based on current clinical developments and competitive analysis, the following projections are estimated:

Year	Estimated Market Share	Revenue (USD Billions)	Notes
2024	0.5% - 1%	$50 - $100 million	Limited launch, early access
2025	2% - 3%	$200 - $318 million	Broader adoption, ongoing clinical data
2026	5% - 8%	$530 - $848 million	Expanded indications, increased awareness

These figures assume a successful FDA and EMA approval in 2023-2024, excluding potential off-label uses or expanded indications.

Key Factors Influencing Growth

1. Regulatory Approval: Timely approval impacts market entry and revenue.
2. Physician Adoption: Education and demonstration of superior efficacy drive uptake.
3. Pricing and Reimbursement: Competitive pricing models and positive reimbursement policies will influence accessibility.
4. Patent Life and Exclusivity: Patent protection until at least 2030 supports sustained revenues.

Long-term Opportunities

Beyond dry eye, potential indications include ocular surface injuries, diabetic keratopathy, and possibly certain neuro-ophthalmic conditions due to the molecule's oxygen-delivery capacity. Research expansions could extend lifecycle and revenue streams.

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Key Challenges

• Clinical Validation: Demonstrating superiority or clear benefit over existing treatments to justify market entry.
• Regulatory Hurdles: Navigating approval pathways across jurisdictions.
• Market Penetration: Overcoming entrenched preferences for standardized therapies.
• Manufacturing Scalability: Ensuring consistent, high-quality production of fluorinated compounds, which pose environmental and regulatory considerations.

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Conclusion

Perfluorohexyloctane stands at a promising juncture, with ongoing clinical trials indicating a favorable safety and efficacy profile. Market dynamics favor a significant uptrend in adoption upon regulatory approval, driven by notable unmet needs in dry eye management. Strategic engagement with healthcare providers, regulatory bodies, and payers will be critical in realizing its commercial potential.

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Key Takeaways

• Clinical Progress: Multiple Phase III trials are underway, with early data supporting safety and efficacy.
• Market Potential: The dry eye treatment market's growth trajectory and unmet needs position perfluorohexyloctane as a promising entrant.
• Competitive Edge: Its fluorinated formulation offers advantages in bioavailability and safety over existing therapies.
• Strategic Outlook: Successful approval and commercialization could generate hundreds of millions in revenue within five years.
• Expansion Opportunities: Potential indications beyond dry eye are worth exploring for long-term growth.

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FAQs

1. When is perfluorohexyloctane expected to gain regulatory approval?
   Based on current clinical trial timelines and regulatory review status, approval could occur by late 2023 or early 2024, assuming positive trial outcomes and regulatory responsiveness.

2. How does perfluorohexyloctane differ from existing dry eye treatments?
   Its fluorinated chemical structure enhances oxygen solubility and stability, potentially offering longer-lasting relief with minimal irritation, contrasting with traditional artificial tears or anti-inflammatory drugs.

3. What are the primary challenges in commercializing perfluorohexyloctane?
   Major challenges include demonstrating clear superiority through clinical data, navigating regulatory pathways across regions, establishing manufacturing scalability, and penetrating a competitive market with entrenched treatment options.

4. Could perfluorohexyloctane be used for other ocular conditions?
   Yes. Its oxygen delivery capacity suggests potential in corneal healing, ocular surface injuries, and diabetic keratopathy. Further research and trials are needed to substantiate these applications.

5. What is the estimated timeline for market entry?
   Assuming positive regulatory developments, initial market entry could happen within 12-18 months post-approval, roughly between late 2023 and 2024.

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References

[1] MarketWatch. "Dry Eye Disease Treatment Market Size, Share & Trends Analysis." 2022.