2.1 Recommended 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.

2.2 Administration 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.

5.1 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 BYQLOVI is used for 10 days or longer, IOP should be monitored.

5.2 Cataracts

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation.

5.3 Delayed Healing

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.

5.4 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 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 .

5.5 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.

5.6 Viral 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).

5.7 Fungal 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.

5.8 Risk of Contamination

Do not allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension.

5.9 Contact Lens Wear

BYQLOVI should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of BYQLOVI. The preservative in BYQLOVI may be absorbed by soft contact lenses. Lenses may be reinserted after 15 minutes following administration of BYQLOVI.

6.1 Clinical 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.

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

The safety and effectiveness of BYQLOVI in pediatric patients have not been established.

8.5 Geriatric 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.

12.1 Mechanism 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 2inhibitory 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.

12.2 Pharmacodynamics

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.

12.3 Pharmacokinetics

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.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16.1 How 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)

16.2 Storage 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.

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.