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DEXYCU (dexamethasone intraocular suspension) 9%, for intraocular administration Initial U.S. Approval: 1958 BRIEF SUMMARY: Please see package insert for full prescribing information. 1 INDICATIONS AND USAGE DEXYCU (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 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. 5.2 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. 5.3 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. Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). 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. 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. 5.4 Cataract Progression The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts. 6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Increase in Intraocular Pressure [see Warning and Precautions (5.1)] Delayed Healing [see Warnings and Precautions (5.2)] Infection Exacerbation [see Warnings and Precautions (5.3)] Cataract Progression [see Warnings and Precautions (5.4)] 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The following adverse events rates are derived from three clinical trials in which 339 patients received the 517 microgram dose of DEXYCU. The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis. Other ocular adverse reactions occurring in 1-5% of subjects included, corneal endothelial cell loss, blepharitis, eye pain, cystoid macular edema, dry eye, ocular inflammation, posterior capsule opacification, blurred vision, reduced visual acuity, vitreous floaters, foreign body sensation, photophobia, and vitreous detachment. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of DEX YCU (dexamethasone intraocular suspension) in pregnant women. Topical ocular administration of dexamethasone in mice and rabbits during the period of organogenesis produced cleft palate and embryofetal death in mice and malformations of abdominal wall/intestines and kidneys in rabbits at doses 7 and 5 times higher than the injected recommended human ophthalmic dose (RHOD) of DEX YCU (517 micrograms dexamethasone), respectively [see Data in the full prescribing information]. In the US general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. There is no information regarding the presence of injected DEXYCU in human milk, the effects on breastfed infants, or the effects on milk production to inform risk of DEXYCU to an infant during lactation. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for DEXYCU and any potential adverse effects on the breastfed child from DEXYCU. 8.4 Pediatric Use Safety and effectiveness of DEX YCU in pediatric patients have not been established. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between older and younger patients. Manufactured for: EyePoint Pharmaceuticals US, Inc. Watertown, MA 02472 DEX0019