BYQLOVI

Clinical summary

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 ) 2.1 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. 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 ) 5.1 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 con