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Kala Pharmaceuticals, Inc. welcomes your comments and clinical inquiries.

US eye care professionals may call Kala at 1-833-287-KALA (1-833-287-5252), or send an email to: medicalaffairs@kalarx.com.

The Safety Data Sheets (SDSs) are intended to provide health, safety and environmental information for the people handling these products in the workplace. The information provided on the SDS is not intended to be used by consumers or patients.

Consumers and patients should consult the product label and package insert for information relevant to their usage. If you have any questions concerning our products or your treatment you should consult a health care professional.

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Important Safety Information

INVELTYS is contraindicated in most 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 diseases of ocular structures.

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.

Use of corticosteroids may result in posterior subcapsular cataract formation.

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 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.

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.

Use 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).

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.

In clinical trials, the most common adverse drug reactions were eye pain (1%) and posterior capsular opacification (1%). These reactions may have been the consequence of the surgical procedure.

Indication

INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Please see Full Prescribing Information.