Safety & Dosing
INVELTYS® was evaluated in 2 clinical studies of cataract surgery patients (vs vehicle) with no concurrent NSAID use1,2*
Low incidence of IOP elevation1
INVELTYS® vs vehicle:
Adapted from Kim T, Sall K, Holland EJ, Brazzell RK, Coultas S, Gupta PK. Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery. Clin Ophthalmol. 2019;13:69-86.
If INVELTYS® is used for 10 days or longer, IOP should be monitored.2
What patients need to know before using2
- Instruct patients to wash hands well before each use.
- Advise patients not to allow the dropper tip to touch any surface as this may contaminate the product.
- If the patient is using other eye medication, instruct them to wait at least 5 minutes between instillation of INVELTYS® and other eye medicines.
- If they wear contact lenses, remind them to remove them before using INVELTYS® and wait 15 minutes after using before putting them back in.
- Instruct patients to notify you if pain develops or if redness, itchiness, or inflammation becomes worse.
- Direct patients to the Instructions For Use for complete information.
BID = twice a day;
IOP = intraocular pressure;
NSAID = nonsteroidal anti-inflammatory drug.
*Clinical efficacy and safety were evaluated in 2 multicentered, randomized, double-masked, placebo-controlled trials in which patients with an anterior cell grade ≥2 (ie, a cell count of 6 or higher using a slit-lamp biomicroscope) after cataract surgery were assigned to INVELTYS® (n=386; Study 1, n=125; Study 2, n=261) or placebo (vehicle) (n=385; Study 1, n=126; Study 2, n=259) following surgery. One to 2 drops of INVELTYS® or vehicle were self-administered twice a day for 14 days beginning the day after surgery. Complete resolution of inflammation (a cell count of 0) and complete resolution of pain (a patient-reported pain grade of 0 [rated via the Subject-Rated Ocular Pain Assessment, 0=none to 5=severe]) were assessed 4, 8, and 15 days postsurgery. Consolidated clinical trial results provided above.2
†N=320; five subjects in the pooled vehicle group did not have any post-baseline IOP measurement.1
REFERENCES
1. Kim T, Sall K, Holland EJ, Brazzell RK, Coultas S, Gupta PK. Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery. Clin Ophthalmol. 2019;13:69-86.
2. INVELTYS®. Prescribing Information. Kala Pharmaceuticals; 2022.
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Indication
INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Important Safety Information
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.
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.
Please see full Prescribing Information for INVELTYS®.