Accessing the Medicare Reimbursement Rate for DEXYCU

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Increase in Intraocular Pressure

• Prolonged use of corticosteroids, including DEXYCU, 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

Delayed Healing

• The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation
• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids

Exacerbation of Infection

• The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of 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 disease of ocular structures
• Use of a corticosteroid in the treatment of patients with a history of herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections
• Fungal infections of the cornea are particularly prone to coincidentally develop with long-term local steroid application and 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
• 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

Cataract Progression

• The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts

ADVERSE REACTIONS

• The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis