Ascorbate Emergency Eyewash, Commercialization
Ascorbate Emergency Eyewash
Beyond Water Irrigation.
A portable, ascorbate-based emergency eyewash that reverses corneal opacity, enhances corneal viability, and substantially reduces cell death compared with the current standard of water irrigation, backed by two years of NEI-funded research and a blinded human clinical trial.
Every major health agency recommends the same thing: water.
OSHA estimates 2.5 million eye injuries occur annually in the workplace.1 Despite decades of research, the universal recommendation after chemical eye exposure remains water irrigation for 10–20 minutes. This project aims to replace both plumbed-in and portable water-based systems with a formulation that actively reverses corneal damage.
| Agency | Recommendation after chemical eye exposure |
|---|---|
| Red Cross | "For chemical splash, flush the eye with water until EMS arrives and begins care." |
| ANSI/ISEA | "…15-minute flush of the eyes with water will provide emergency first aid mitigation of corrosive or caustic splash exposures." |
| DHHS | "Rinse the eye immediately for at least 15 minutes with water OR hold face under a faucet to rinse the eye." |
| EPA | "…hold the eyelid open and wash with clean running water or a gentle stream from a hose for at least 15 minutes." |
| Harvard Health | "It is best to use cool running water and to continue to rinse for at least 10 minutes." |
| Mayo Clinic | "If a chemical splashes into your eye…flush your eye with clean, lukewarm tap water for at least 20 minutes." |
| NEI | "…Wash your eye out with water for at least 10 minutes." |
| NIH Medline | "Holding the eyelid open, allow running water from the faucet to flush the eye for 15 minutes." |
| NIOSH | "Immediately wash the eyes with large amounts of water, occasionally lifting the lower and upper lids." |
| OSHA | "Installed and portable emergency eyewash units be capable of delivering clean water continuously for at least 15 minutes." |
ANSI = American National Standards Institute; ISEA = International Safety Equipment Association; DHHS = Department of Health and Human Services; EPA = Environmental Protection Agency; NEI = National Eye Institute; NIH = National Institutes of Health; NIOSH = National Institute for Occupational Safety and Health; OSHA = Occupational Safety and Health Administration.
A two-part kit that mixes fresh at the point of injury.
The Ascorbate Emergency Eyewash kit contains two sets (in case both eyes are affected), each comprising three parts: Part 1, the emergency eyewash buffer solution; Part 2, the vitamin C (ascorbate) supplement; Part 3, the irrigation cup. The vitamin C is added to the buffer immediately before use, mixed by inversion, and the eye is irrigated continuously for 15 minutes. The fresh-mixing approach is the core of the patent, no prior art has a temporal concept where the mixture is made within 10 minutes of injury.
Remove cap & add supplement
Open the eyewash buffer bottle (Part 1) and add the vitamin C supplement (Part 2).
Cap and mix by inversion
Replace the cap and invert the bottle five times to fully dissolve the supplement.
Irrigate for 15 minutes
Place the irrigation cup (Part 3) over the eye and compress the bottle continuously to maintain flow.
Clinical tolerability trial result
In a blinded, 12-subject crossover study, 0 of 12 subjects reported any adverse effects or irritation from the ascorbate eyewash formulation. By contrast, 2 of 12 subjects reported irritation from water in the contralateral eye. An ophthalmologist examination confirmed no signs of irritation or adverse ocular effects for the eyewash group.4
Why our eyewash wins.
Clinically Superior to Water
Ex vivo studies show significantly better outcomes after chemical eye exposure compared to the current standard of water irrigation, reversing corneal opacity, enhancing corneal viability, and substantially reducing cell death.
Human Clinical Safety Confirmed
A blinded clinical tolerability trial in 12 subjects found zero adverse ocular effects for the eyewash formulation. By contrast, 2 of 12 subjects reported irritation from water in the contralateral eye.
Portable & Shelf-Stable
Formulated as a two-part kit, eyewash buffer + vitamin C supplement, that mixes fresh at point of use. Designed for a minimum 1-year shelf life, suitable for ambulances, personal safety kits, and remote locations.
No Direct Patent Competition
An extensive patent database search (709 hits) found no relevant prior art combining an eyewash buffer system with vitamin C for emergency use. The temporal "freshly mixed within 10 minutes of injury" concept is entirely novel.
Strong IP Position
PCT/US/2024/048093 filed internationally. US application USSN 18/994,433 granted expedited PPH examination status. Composition claims found novel, inventive, and industrially applicable by the international searching authority.
Compelling Unit Economics
Retail price: $795/kit. Direct materials cost: ~$74/kit. Estimated profit: ~$496/kit. Sold in units of 5 kits ($3,975/unit, ~$2,480 profit/unit). GMP-capable 1,800 ft² facility already operational.
A $1.5 billion US market growing at 7.5% annually.
The US eyewash station market is valued at $1.5 billion in 2024, projected to reach $2.8 billion by 2033.2 The global market is estimated as high as $100 billion. North America holds the largest worldwide market share for eyewash bottles. OSHA and ANSI/ISEA Z358.1 mandates3 drive adoption across approximately 330,000 US facilities, from small laboratories (1–3 kits/year) to large institutions (20–50 kits/year).
Revenue projections (post-FDA OMOR acceptance)
Based on 1 unit = 5 eyewash kits at $3,975/unit. Direct materials cost ~$370/unit. Profit ~$2,480/unit.
| Year | Revenue | Volume | Market share |
|---|---|---|---|
| Year 1 | $1.3M | 27.5 units/mo | 0.1% market |
| Year 2 | $13.1M | 275 units/mo | 1% market |
| Year 3 | $26.2M | 550 units/mo | 2% market |
| Year 4 | $52.5M | 1,100 units/mo | 4% market |
| Year 5 | $104.9M | 2,200 units/mo | 8% market |
Strong, novel IP with no direct competition.
An extensive patent search across 709 results found no prior art combining an eyewash buffer system with vitamin C for emergency use. The international searching authority found multiple claims novel, inventive, and industrially applicable. The "freshly mixed within 10 minutes of injury" temporal concept is entirely absent from the prior art.
US20250262123A1
Emergency Eyewash
Lebrun Labs LLC, our pending US patent application. Composition claims found novel and inventive by international searching authority.
PCT/US/2024/048093
Emergency Eyewash (International)
International PCT filing. Positive Written Opinion. Foreign patent portfolio in development across PCT member countries.
USSN 18/994,433
Emergency Eyewash, PPH
Patent Prosecution Highway application granted expedited examination status. Allowance expected within months.
Competitive landscape summary
Existing competitors (Acorn Safety, Aqua Safety Showers, Bradley®, Honeywell, etc.) specialize in plumbed eyewash stations and showers. Where portable solutions exist, the reagent is water or saline, not an active therapeutic formulation. No identified patents or active NIH-funded projects represent a direct competitor to the OptiSafe Emergency Eyewash buffer system.
- No prior art combines eyewash buffer + vitamin C for emergency use
- Existing portable products use water or saline, no active ingredient
- The ascorbate eyewash requires smaller fluid volume than plumbed systems
- Suitable for ambulances, personal safety kits, and remote locations
- NIH-funded project search (709 results) found zero direct competitors
FDA OTC monograph pathway, no new drug application required.
The Ascorbate Emergency Eyewash contains ingredients and formulations already covered by an existing OTC monograph. If the product meets all conditions (statement of identity, uses, warnings, directions), it can be marketed without submitting a new drug application. Anticipated FDA regulatory waivers allow for a streamlined monograph submission. Total regulatory timeline: 1–2 years after submission.
Confirm monograph compliance
Verify ingredients, dosage, labeling, and claims align with the OTC ophthalmic monograph.
Prepare Monograph Order Request (MOR)
Cover letter, product description, active ingredients, safety and efficacy data, rationale for inclusion.
FDA administrative review
Estimated 1–3 months. FDA proceeds to scientific review or requests additional information.
FDA scientific evaluation
Safety, efficacy, and labeling review. GRASE determination. Estimated 6–12 months.
Public comment period
45–90 day Federal Register comment period after proposed monograph order published.
Final order & market entry
If approved, product can be marketed immediately without a separate new drug application.
Alternative pathway
If the OTC monograph order request is not accepted, Lebrun Labs will pursue an Abbreviated New Drug Application (ANDA), which allows submission without preclinical or clinical data to establish safety and effectiveness. The FDA's New Alternative Methods Program further supports in vitro approaches aligned with Lebrun Labs' existing nonanimal testing expertise.
Multi-channel distribution strategy.
Direct online sales
Company website storefront
Amazon storefront
North America's largest eyewash bottle market
Scientific distributors
Thermo Fisher, Sigma-Aldrich, Cole-Parmer, Grainger, ULINE
Trade shows & events
Society of Toxicology, National Safety Council, AIHA
Manufacturing readiness
Lebrun Labs operates a GMP-capable 1,800 ft² production facility dedicated to kit manufacturing, with a QA unit experienced in SOPs, batch records, and current GMPs. The PI has 20 years of manufacturing experience; the lab manager has 3+ years formulating, making, and testing the specific eyewash formula. Scale-up target: 2,200+ units/month.
- GMP-capable facility, 1,800 ft² dedicated production space
- QA unit with SOP writing, document record-keeping, and GMP compliance
- Existing kit manufacturing experience (sterile bottle fills, packaging)
- Scale-up target: 2,200 units/month (5 kits/unit = 11,000 kits/month)
Multiple paths to commercialization.
The SBIR-funded research positions Lebrun Labs to pursue licensing revenue and partnership deals with scientific supply and emergency safety companies. The primary commercialization path is to demonstrate broad utility through publications and trade shows, achieve FDA OMOR acceptance, launch online sales, and grow to a sustainable bootstrapped level. Equity investment and venture capital remain available options, particularly if the ANDA pathway is required.
Strategic partnerships
Licensing or distribution agreements with Thermo Fisher, Sigma-Aldrich, Cole-Parmer, Grainger, ULINE, and similar scientific supply companies.
Equity investment
Accelerate manufacturing scale-up, regulatory submission, and market entry. The PI has an established network of potential investors and industry connections.
Bootstrapped online sales
Direct website and Amazon storefront sales reaching half of Year 1 forecast would enable a self-sustaining growth trajectory without external capital.
Interested in partnering or investing?
Lebrun Labs is actively seeking strategic partners, distributors, and investors to accelerate the commercialization of the Ascorbate Emergency Eyewash. Contact us to request the full commercialization plan or discuss partnership terms.
References
- 1. OSHA. (2023). Eye and Face Protection. Occupational Safety and Health Administration, U.S. Department of Labor. https://www.osha.gov/eye-face-protection
- 2. Grand View Research. (2024). Eye Wash Station Market Size, Share & Trends Analysis Report. Grand View Research, Inc. https://www.grandviewresearch.com/industry-analysis/eye-wash-station-market
- 3. ANSI/ISEA Z358.1-2014 (R2020). American National Standard for Emergency Eyewash and Shower Equipment. International Safety Equipment Association. https://www.isea.org/page/Z3581
- 4. [LL] Lebrun S, Nguyen L. (2026b). U.S. Patent No. US12648892B2: Emergency Eye Wash. United States Patent and Trademark Office. Granted June 9, 2026. Assignee: Lebrun Labs LLC. Clinical tolerability trial data reported in patent specification. https://patents.google.com/patent/US12648892B2/en
- 5. [LL] Lebrun S, Nguyen L. (2024b). WIPO PCT Application WO2024177860A1: In Chemico Test for Toxicity. World Intellectual Property Organization. Published August 29, 2024. https://patents.google.com/patent/WO2024177860A1/en
- 6. NIH/NEI Grant R21 EY033713. Antioxidant Eye Wash Formulations to Counter Ocular Chemical Threats. National Eye Institute, National Institutes of Health. NIH Reporter: 10631664
- 7. Red Cross. Emergency eye exposure guidance. https://www.redcross.org/take-a-class/resources/articles/eye-injuries
- 8. ANSI/ISEA. Emergency eye exposure guidance. https://www.isea.org/page/Z3581
- 9. DHHS. Emergency eye exposure guidance. https://www.cdc.gov/niosh/topics/eye/default.html
- 10. EPA. Emergency eye exposure guidance. https://www.epa.gov/emergency-response/emergency-response-resources
- 11. Harvard Health. Emergency eye exposure guidance. https://www.health.harvard.edu/a_to_z/eye-injuries-a-to-z
- 12. Mayo Clinic. Emergency eye exposure guidance. https://www.mayoclinic.org/first-aid/first-aid-eye-emergency/basics/art-20056647
- 13. NEI. Emergency eye exposure guidance. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/eye-injuries
- 14. NIH Medline. Emergency eye exposure guidance. https://medlineplus.gov/ency/article/000054.htm
- 15. NIOSH. Emergency eye exposure guidance. https://www.cdc.gov/niosh/topics/eye/default.html
- 16. OSHA. Emergency eye exposure guidance. https://www.osha.gov/laws-regs/standardinterpretations/2003-04-17
[LL] = Lebrun Labs LLC patent or publication. All agency quotes are verbatim excerpts from the cited public guidance documents. Revenue projections are Lebrun Labs internal estimates based on cited market data.