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Inveltys FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 29, 2018.

FDA Approved: Yes (First approved August 22, 2018)
Brand name: Inveltys
Generic name: loteprednol etabonate
Dosage form: Ophthalmic Suspension
Company: Kala Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Inveltys (loteprednol etabonate) is a nanoparticle ocular corticosteroid formulation for the treatment of post-operative ocular inflammation and pain.

Dosage and Administration

  • Shake the bottle for one to two seconds before using.
  • Instill one to two drops of Inveltys into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.
  • Do not to allow the dropper tip to touch any surface, as this may contaminate the suspension.
  • Consult a physician if pain, redness, or itching develops, or if inflammation becomes aggravated.
  • The preservative in Inveltys may be absorbed by soft contact lenses. Remove contact lenses prior to instillation of Inveltys. Contact lenses can be reinserted 15 minutes following administration of the drops.


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.

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. If this product is used for 10 days or longer, IOP should be monitored.
  • Cataracts - Use of corticosteroids may result in posterior subcapsular cataract formation.
  • Delayed healing - 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.
  • 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.
  • Viral infections - 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 - 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.

Adverse Reactions

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.

Development timeline for Inveltys

Aug 23, 2018Approval FDA Approves Inveltys (loteprednol etabonate) for Post-Operative Inflammation and Pain Following Ocular Surgery
Jan  5, 2018Kala Pharmaceuticals Announces New Drug Application for Inveltys (KPI-121 1%) Has Been Accepted for Review by the U.S. Food and Drug Administration
Oct 25, 2017Kala Pharmaceuticals Submits NDA to U.S. Food And Drug Administration for Inveltys (KPI-121 1%)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.