FDA label 44fdffcc-1f20-6598-e063-6294a90aba36

5 WARNINGS AND PRECAUTIONS Increase in Intraocular Pressure (IOP) : Monitor for increases in IOP ( 5.1 ). Delayed Healing : Monitor for delayed healing ( 5.2 ). Infection Exacerbation : Monitor and treat for any exacerbations of bacterial, viral or fungal infections ( 5.3 ). Cataract Progression : Cataracts may develop or progress in phakic patients ( 5.4 ). 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 Warnings 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) ] In controlled studies, the most common adverse reactions reported by 5-15% of patients were intraocular pressure increased, corneal edema and iritis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact EyePoint Pharmaceuticals US at 1-833-EYEPOINT (1-833-393-7646) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials 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 trials 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.