The
first and only corticosteroid
FDA approved for BID treatment
of post-operative inflammation and pain
following ocular surgery

BID STRONG
boat
BID STRONG

Powered by AMPPLIFY™ Drug Delivery Technology

INVELTYS
INVELTYS is powered by
AMPPLYIFY
Drug Delivery Technology, utilizing
Mucus-Penetrating Particles, with 2 proprietary attributes1:
nano particle
Selectively sized
nanoparticles to allow
for penetration into mucus pores
Mucus-penetrating surface coating
to prevent adherence to mucus

Designed to enhance penetration through the mucus barrier and deliver increased concentration of loteprednol etabonate to the target ocular tissue

Traditional suspension eye drops adhere to mucins and can be rapidly cleared through blinking
In a preclinical study, AMPPLIFY™ delivered 3.75x more loteprednol etabonate to the aqueous humor compared to an active comparator without AMPPLIFY™2*
  • 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 traditional loteprednol etabonate suspension 0.5%. 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.

Proven BID Efficacy

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:

  • 24% vs 13% at Day 8 
    (93/386)  (51/385)
  • 50% vs 27% at Day 15 
    (193/386)  (102/385)
ZERO pain in nearly 70% of patients by Day 15

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

  • 43% vs 25% at Day 4 
    (164/386)  (96/385)
  • 56% vs 36% at Day 8 
    (216/386)  (139/385)
  • 69% vs 48% at Day 15 
    (286/386)  (186/385)

INVELTYS has the highest available concentration of loteprednol etabonate (1%)

  • Clinical efficacy and safety were evaluated in 2 multicenter, 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 maintained through Day 15 without rescue medication) 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] maintained through Day 15 without rescue medication) were assessed 4, 8, and 15 days postsurgery. Consolidated clinical trial results provided above.

A Low Incidence
of Significant
Intraocular Pressure (IOP) Elevations Vs Vehicle

Incidence of significant IOP elevations (≥10 mm Hg increase from baseline with a
total measurement of ≥21 mm Hg) was similar to vehicle2:

  • 0.5% (2/386) for INVELTYS vs 0 (0/385) for vehicle at Day 4
If INVELTYS is used for 10 days or longer, IOP should be monitored.
bottle

Proven BID efficacy in the treatment of post-operative
inflammation and pain following ocular surgery

bottle
  • 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

A Commitment to Patient Access: The Co-pay Program for INVELTYS

Copay Card

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 $35

Copay Card

For eligible patients whose prescriptions for INVELTYS are not covered by either commercial or government insurance, use of the co-pay card may reduce the cost of INVELTYS to AS LITTLE AS $55

 

Restrictions and conditions apply.


Thoughts from Ophthalmic Experts

Preeya Gupta, MD

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

—Preeya Gupta, MD

Preeya Gupta, MD

What is AMPPLIFY™ Drug Delivery Technology?

—Preeya Gupta, MD

Preeya Gupta, MD

Why is BID dosing important for your patients?

—Edward Holland, MD

Preeya Gupta, MD

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

—John Sheppard, MD

Preeya Gupta, MD

How would you describe the intraocular pressure profile of INVELTYS?

—Terry Kim, MD

Preeya Gupta, MD

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.