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THE ONLY 1% FORMULATION of loteprednol etabonate (LE).

THE ONLY MUCOPENETRATING technology for ophthalmic use.

THE ONLY corticosteroid FDA approved for BID TREATMENT of
post-operative inflammation and pain following ocular surgery.

ONLY INVELTYS ISBID STRONG

BID STRONG with...1% LE and Mucopenetrating Power

AMPPLIFY Drug Delivery Technology enhances penetration through the mucus barrier using 2 proprietary attributes1:

AMPPLIFY nanoparticle AMPPLIFY nanoparticle
Particles must be <500 nm to penetrate into mucus pores2-4; AMPPLIFY® nanoparticles are ≈300 nm
Traditional suspension eye drops adhere to mucins; AMPPLIFY® nanoparticles have a mucus-penetrating surface coating to prevent adherence to mucus

AMPPLIFY® delivered more LE to target ocular tissues vs Lotemax® Suspension5

Bar chart showing peak concentrations in cornea are higher with loteprednol etabonate 1.0% with AMPPLIFY® after 5 minutes post-dose.
Bar chart showing peak concentrations in aqueous humor are 3.75 times higher with loteprednol etabonate 1.0% with AMPPLIFY® after 30 minutes post-dose.

*Data from an in vivo preclinical study in 36 male rabbits, aged 6 months. Animals were randomized to receive either loteprednol etabonate 1% with AMPPLIFY® Drug Delivery Technology or Lotemax ®Suspension. Concentrations of study drugs in the aqueous humor and cornea were assayed at 5 minutes, 15 minutes, 30 minutes, 1.0, 3.0, and 6.0 hours postdosing. Clinical significance of this preclinical data has not been established.

Traditional suspension eye drops adhere to mucins and can be rapidly cleared through blinking

Drug particles formulated with AMPPLIFY® are designed to enhance penetration through the mucus barrier and deliver increased concentrations to the target ocular tissues

Inveltys (loteprednol etabonate ophthalmic suspension) 1% powered by AMPPLIFY drug delivery technology
Watch video about AMPPLIFY™ DRUG DELIVERY TECHNOLOGY (opens video in modal dialog)

BID STRONG with...Proven BID Efficacy AND A LOW RISK OF SIGNIFICANT IOP ELEVATIONS

In 2 clinical studies of cataract surgery patients
(vs vehicle) with no concurrent NSAID use (P<0.01)*

ZERO Inflammation in 50% of patients
by Day 15

Complete resolution of inflammation (anterior chamber cell count=0), INVELTYS vs vehicle:

(93/386)(51/385)
(193/386)(102/385)

ZERO Pain in nearly 70% of patients
by Day 15

Complete resolution of pain (grade=0), INVELTYS vs vehicle:

(164/386)(96/385)
(216/386)(139/385)
(268/386)(186/385)

LOW Incidence of significant intraocular
pressure (IOP) elevations5

Incidence of significant IOP elevations (≥10 mm Hg increase from baseline with a total measurement of ≥21 mm Hg), INVELTYS vs vehicle:

(2/386)(0/385) If INVELTYS
is used for
10 days or longer,
IOP should be
monitored.

*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.

BID STRONG with...Proven BID Efficacy in the treatment of post-operative inflammation and pain following ocular surgery

bottle of Inveltys (loteprednol etabonate ophthalmic suspension) 1%
  • Shake bottle for 1 to 2 seconds before using
  • Instill 1 to 2 drops into the affected eye twice daily, beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period
  • Contact lenses should be removed prior to instillation of INVELTYS and may be reinserted after 15 minutes following administration

BID STRONG with...a Commitment to patient Access

BID STRONG with...a Commitment to patient Access

The Co-pay Program for INVELTYS

For eligible patients whose prescriptions for INVELTYS are covered by commercial insurance, use of the co-pay card may reduce co-payment responsibility to
AS LITTLE AS $40

For eligible patients whose prescriptions for INVELTYS are not covered by either commercial or government insurance, use of the co-pay card may reduce co-payment responsibility to
AS LITTLE AS $60

Restrictions and conditions apply.

Thoughts from Ophthalmic Experts

Watch video: How do mucins in the tear film affect eye drop delivery? (opens video in modal dialog)

How do mucins in the tear film affect eye drop delivery?

Preeya Gupta, MD

Watch video: Why is BID dosing important for your patients? (opens video in modal dialog)

Why is BID dosing important for your patients?

Edward
Holland, MD

Watch video: How would you describe the intraocular pressure profile of INVELTYS? (opens video in modal dialog)

How would you describe the intraocular pressure profile of INVELTYS?

Terry Kim, MD

Watch video: What is AMPPLIFY® Drug Delivery Technology? (opens video in modal dialog)

What is AMPPLIFY® Drug Delivery Technology?

Preeya Gupta, MD

Watch video: Why would you prescribe INVELTYS for the management of pain and inflammation following ocular surgery? (opens video in modal dialog)

Why would you prescribe INVELTYS for the management of pain and inflammation following ocular surgery?

John
Sheppard, MD

Watch video: What should I tell my patients to do if the pharmacy tries to switch their prescription? (opens video in modal dialog)

What should I tell my patients to do if the pharmacy tries to switch their prescription?

Eric
Donnenfeld, MD

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 for INVELTYS.