BID relief, with proven
efficacy1
INVELTYS® was evaluated in 2 clinical studies of cataract surgery patients (vs vehicle) with no concurrent NSAID use1,2*
Complete resolution of anterior chamber cells† in 50% of patients by Day 151,2
INVELTYS® vs vehicle:
Consolidated clinical trial data: percentage of patients with complete resolution of chamber cells (cell count=0)
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.
Complete resolution of pain‡ in nearly 70% of patients by Day 151,2
INVELTYS® vs vehicle:
Consolidated clinical trial data: percentage of patients with complete resolution of pain
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.
BID = twice a day;
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 are provided above.1,2
†Complete resolution of inflammation defined as an anterior chamber cell count of 0.1
‡Complete resolution of pain defined as grade=0.1
REFERENCES
1. INVELTYS®. Prescribing Information. Kala Pharmaceuticals; 2022.
2. Kim T, Sall K, Holland EJ, Brazzell RK, Coultas S, Gupta PK. Safety and efficacy of twice dailyadministration of KPI-121 1% for ocular inflammation and pain following cataract surgery. Clin Ophthalmol. 2019;13:69-86.
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®.