CLOBETASOL PROPIONATE .5 mg/mL Suspension/ Drops, 1 bottle — NDC 81046-0319-1 (Billing 81046-0319-01)
This is a package of 1 bottle of CLOBETASOL PROPIONATE .5 mg/mL Suspension/ Drops from Eyenovia, Inc., marketed since Mar 2024 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 81046-0319-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 81046 labeler · 0319 product · 1 package
- Package marketed since
- Mar 25, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 8104603191 4
- FDA record last changed
- Jul 24, 2026
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 086381
- GCN: 56088
- HICL (First Databank): 003327
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 2683740
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It calms inflamed, itchy skin and scalp conditions, including plaque psoriasis. The exact use depends on your product, such as shampoo for scalp psoriasis or spray for plaque psori...
- Usually only a short time, often 2 weeks and up to 4 weeks for some products. Stop when your skin is under control. If you see no improvement in 2 weeks, check back with your presc...
- Generally no. Most clobetasol skin products should not be used on the face, armpits or groin. Keep it out of your eyes and mouth, and follow your product's directions.
- Mild burning, stinging, itching or dryness where you apply it. Call your doctor if your skin thins, breaks out, looks infected or gets worse. Also call for signs of steroid effects...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:
Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 81046-0319-01 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 3.5 mL in 1 BOTTLE, DROPPER | 2024-03-25 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clobetasol Propionate .5 mg/mLthis 81046-0319-01 | Eyenovia, | 1 bottle | — | — | FDA listed | — |
| Byqlovi .5 mg/mL 82667-0021-00 | Harrow | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11376262 ↗ | Method of use | U-19 | May 9, 2036 |
| US 10588913 ↗ | Drug product | — | May 9, 2036 |
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | Mar 4, 2027 |
Is there a generic version of CLOBETASOL 0.05% EYE DROP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Clobetasol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII RS7A450LGA
A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII H1109Z9J4N
A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
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UNII Z944H5SN0H
A plant-based thickening agent derived from cellulose. It acts as a binder to hold tablet ingredients together and as a thickener in liquid formulations to achieve the right consistency.
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UNII TUF2IVW3M2
Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery. BYQLOVI is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill one drop of BYQLOVI into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. ( 2.1 ) Wash hands well before each use. ( 2.2 )
2.1Recommended Dosage Instill one drop of BYQLOVI into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.
2.2Administration Instructions Wash hands well before each use. If using other eye drops in addition to BYQLOVI, wait at least 5 minutes between instillation of BYQLOVI and other eye drops.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic suspension containing clobetasol propionate 0.05% (0.5 mg/mL). Ophthalmic suspension containing clobetasol propionate 0.05%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS BYQLOVI is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. BYQLOVI is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Intraocular Pressure (IOP) Increase : Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, IOP should be monitored.
( 5.1 ) Cataracts : Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed Healing : The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. ( 5.3 ) Corneal and Scleral Melting : In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. ( 5.4 ) Bacterial Infections : Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection.
If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. ( 5.5 ) Viral Infections : Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
( 5.6 ) Fungal Infections : Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.
( 5.7 )
5.1Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If BYQLOVI is used for 10 days or longer, IOP should be monitored.
5.2Cataracts Prolonged use of corticosteroids may result in posterior subcapsular cataract formation.
5.3Delayed Healing The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.
5.4Corneal and Scleral Melting In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining .
5.5Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated.
5.6Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
5.7Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal culture should be taken when appropriate.
5.8Risk of Contamination Do not allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension.
5.9Contact Lens Wear BYQLOV… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: Intraocular Pressure (IOP) Increase [see Warnings and Precautions (5.1) ] Posterior Subcapsular Cataract Formation [see Warnings and Precautions (5.2) ] Delayed Healing [see Warnings and Precautions (5.3) ] Corneal and Scleral Melting [see Warnings and Precautions (5.4) ] Bacterial Infections [see Warnings and Precautions (5.5) ] Viral Infections [see Warnings and Precautions (5.6) ] Fungal Infections [see Warnings and Precautions (5.7) ] Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%).
Many of these reactions may have been the consequence of the surgical procedure ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. at 1-833-393-6684 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%).
Many of these reactions may have been the consequence of the surgical procedure.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled clinical studies of BYQLOVI administration in pregnant women to inform drug-associated risks. Plasma concentrations of clobetasol propionate were minimal following topical ophthalmic administration of BYQLOVI [see Clinical Pharmacology (12.3) ] . However, corticosteroids, including clobetasol propionate have been shown to be teratogenic and fetotoxic in laboratory animals when administered systemically at relatively low dosage levels (see Data ) .
BYQLOVI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryofetal development studies in mice, clobetasol propionate was fetotoxic at the highest subcutaneous dose tested (1 mg/kg) and teratogenic at all subcutaneous dose levels tested down to 0.03 mg/kg.
Abnormalities observed included cleft palate and skeletal abnormalities. These doses are approximately 98 times and 3 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption. In embryofetal development studies in rabbits, clobetasol propionate was teratogenic at subcutaneous doses of 3 and 10 µg/kg.
Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. These doses are approximately 1.2 times and 3.9 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption.
8.2Lactation Risk Summary There is no information regarding the presence of clobetasol propionate in human milk, the effects on the breastfed infant, or the effects on milk production. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. However, systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3) ], and it is not known whether measurable levels of clobetasol propionate would be present in maternal milk following topical ocular administration.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BYQLOVI, and any potential adverse effects on the breastfed infant from BYQLOVI.
8.4Pediatric Use The safety and effectiveness of BYQLOVI in pediatric patients have not been established.
8.5Geriatric Use No overall differences in safety and effectiveness of BYQLOVI have been observed between patients 65 years of age and older and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled clinical studies of BYQLOVI administration in pregnant women to inform drug-associated risks. Plasma concentrations of clobetasol propionate were minimal following topical ophthalmic administration of BYQLOVI [see Clinical Pharmacology (12.3) ] . However, corticosteroids, including clobetasol propionate have been shown to be teratogenic and fetotoxic in laboratory animals when administered systemically at relatively low dosage levels (see Data ) .
BYQLOVI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryofetal development studies in mice, clobetasol propionate was fetotoxic at the highest subcutaneous dose tested (1 mg/kg) and teratogenic at all subcutaneous dose levels tested down to 0.03 mg/kg.
Abnormalities observed included cleft palate and skeletal abnormalities. These doses are approximately 98 times and 3 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption. In embryofetal development studies in rabbits, clobetasol propionate was teratogenic at subcutaneous doses of 3 and 10 µg/kg.
Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. These doses are approximately 1.2 times and 3.9 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of BYQLOVI in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety and effectiveness of BYQLOVI have been observed between patients 65 years of age and older and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.
It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
12.2Pharmacodynamics In patients treated with BYQLOVI twice daily for 21 days, the mean (SD) changes from baseline in cortisol concentrations, -18.1 (126.2) nmol/L and +5.1 (129.8) nmol/L for the BYQLOVI and matching vehicle arms, respectively, were not statistically significant, considering the variability observed in the cortisol concentrations.
12.3Pharmacokinetics After the first and second (12 hours apart) ocular instillations of BYQLOVI in healthy adults (n=12), peak plasma clobetasol propionate concentrations (C max ) were below the lower limit of quantitation (LLOQ, 0.04 ng/mL) in 13 out of 22 PK profiles and ranged from 0.040 to 0.182 ng/mL in the other 9 profiles. Time to peak concentration (T max ) was observed between 0.5 - 1 hour post-dose. Clobetasol propionate concentrations declined to lower than LLOQ after 4 to 5 hours post-dose.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.
It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% (0.5 mg/mL) is a sterile ophthalmic suspension. It is supplied in a multi-dose white low-density polyethylene plastic 5 mL eye-dropper bottle with a low-density polyethylene white tip and a high-density polyethylene pink cap with a tamper-proof ring at the bottom of the cap. 3.5 mL in a 5 mL bottle (NDC 81046-0319-1)
16.2Storage and Handling Do not use if tamper-evident ring seal is broken. Keep the bottle tightly closed with the pink cap when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, BYQLOVI can be used until the expiration date on the bottle.
📦 Storage and Handling ▾
16.2Storage and Handling Do not use if tamper-evident ring seal is broken. Keep the bottle tightly closed with the pink cap when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, BYQLOVI can be used until the expiration date on the bottle.
📋 Description ▾
11 DESCRIPTION BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, that has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate and it has the following structural formula: Clobetasol propionate has the empirical formula C 25 H 32 CIFO 5 and a molecular weight of 467.
BYQLOVI contains a sterile, anti-inflammatory corticosteroid for topical ophthalmic use. Each mL of BYQLOVI contains: ACTIVE: clobetasol propionate 0.5 mg (0.05%) INACTIVES: sodium chloride, hydrogenated soybean lecithin, citric acid, glycerin, poloxamer 407, polyvinyl alcohol, boric acid, edetate disodium dihydrate, methylcellulose, trisodium citrate, and water for injection PRESERVATIVE: benzalkonium chloride 0.0036%. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration with Other Eye Drops Advise patients to wait at least 5 minutes between instillation of BYQLOVI and other eye drops if using other eye drops in addition to BYQLOVI. Risk of Contamination Advise patients to wash their hands well before each use. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension.
When to Seek Physician Advice Advise patients to consult a physician if pain develops; or if redness, itching, or inflammation becomes aggravated. Contact Lens Wear Advise patients that the preservative in BYQLOVI may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of BYQLOVI and may be reinserted after 15 minutes following administration.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics After the first and second (12 hours apart) ocular instillations of BYQLOVI in healthy adults (n=12), peak plasma clobetasol propionate concentrations (C max ) were below the lower limit of quantitation (LLOQ, 0.04 ng/mL) in 13 out of 22 PK profiles and ranged from 0.040 to 0.182 ng/mL in the other 9 profiles. Time to peak concentration (T max ) was observed between 0.5 - 1 hour post-dose. Clobetasol propionate concentrations declined to lower than LLOQ after 4 to 5 hours post-dose.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In patients treated with BYQLOVI twice daily for 21 days, the mean (SD) changes from baseline in cortisol concentrations, -18.1 (126.2) nmol/L and +5.1 (129.8) nmol/L for the BYQLOVI and matching vehicle arms, respectively, were not statistically significant, considering the variability observed in the cortisol concentrations.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Clinical efficacy was evaluated in 2 multi-center, randomized, double-masked, vehicle-controlled trials in which patients had ≥10 cells in the anterior chamber after cataract surgery were assigned to BYQLOVI 0.05% (N=366) or vehicle (N=382) ( NCT04739709 (Study 1) and NCT04810962 (Study 2)). One drop of Clobetasol Propionate Ophthalmic Suspension 0.05% or vehicle was self-administered twice a day for 14 days, beginning on the day after surgery. Complete resolution of inflammation (an anterior chamber cell count of 0 maintained through Day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through Day 15 without rescue medication) were assessed at post-operative day (POD) 4, 8, and 15.
(Study 1) and NCT04810962 (Study 2)). One drop of BYQLOVI 0.05% or vehicle was self-administered twice a day for 14 days, beginning on the day after surgery. Complete resolution of inflammation (an anterior chamber cell count of 0 maintained through Day 15 without rescue medication) and complete resolution of pain (a patient-reported pain grade of 0 maintained through Day 15 without rescue medication) were assessed at post-operative day (POD) 4, 8, and 15.
The co-primary efficacy endpoints were the proportion of subjects with Anterior Chamber Cell (ACC) count = 0 (ACC grade = 0) at POD8 maintained through POD15, and the proportion of subjects with Ocular Pain Grade = 0 at POD4 maintained through POD15. In the intent-to-treat analysis, both co-primary efficacy endpoints were statistically significantly better in BYQLOVI 0.05%-treated patients compared to vehicle-treated patients (p<0.01). The clinical trial efficacy results from both studies are provided below.
Figure 1: Percent of Patients with Anterior Chamber Cell Count = 0 at Post-Operative Days 8 and 15 Figure 2: Percent of Patients with Complete Resolution of Pain at Post-Operative Days 4, 8, and 15 Figure 1 Figure 1 Figure 2 Figure 2
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been performed with BYQLOVI to evaluate the carcinogenic potential of clobetasol propionate. Mutagenesis Clobetasol propionate was not mutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. Impairment of Fertility Fertility studies in the rat following subcutaneous administration at dosage levels up to 50 µg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
This dose is approximately 10 times the recommended human ophthalmic dose of BYQLOVI (0.83 μg/kg/day), estimated based on body surface area and assuming 100% systemic absorption. Note that systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3) ] .
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been performed with BYQLOVI to evaluate the carcinogenic potential of clobetasol propionate. Mutagenesis Clobetasol propionate was not mutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. Impairment of Fertility Fertility studies in the rat following subcutaneous administration at dosage levels up to 50 µg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
This dose is approximately 10 times the recommended human ophthalmic dose of BYQLOVI (0.83 μg/kg/day), estimated based on body surface area and assuming 100% systemic absorption. Note that systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3) ] .
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 3.5 mL Bottle and Carton Labels NDC #: 81046-0319-1 BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% FOR TOPICAL APPLICATION IN THE EYE Sterile Rx only 3.5 mL eyenovia Bottle Label Carton Label PRINCIPAL DISPLAY PANEL - 3.5 mL Bottle Carton PRINCIPAL DISPLAY PANEL - 3.5 mL Bottle Carton
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