LARGEST BRANDED OPHTHALMIC NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) CLINICAL TRIAL PROGRAM1-3,*

ILEVRO® 0.3% dosed 1x daily was noninferior to NEVANAC® (nepafenac ophthalmic suspension) 0.1% dosed 3x daily for inflammation clearing and resolution of ocular pain at day 14 following cataract surgery.1,4

*Since 2005

Study Design

2 STUDIES, 2,928 TOTAL ADULT PATIENTS1,4

Results from 2 randomized, multicenter, controlled, double-masked trials of adult patients undergoing cataract extraction.1,4

SMALLER PARTICLE SIZE, TWICE THE DRUG CONCENTRATION4

  • Smaller particle size: approximately 40% smaller than NEVANAC® Suspension 4
  • Twice the drug concentration delivered in target tissue compared to NEVANAC® Suspension 4
  • Increased surface area of dissolution compared to NEVANAC® Suspension4
  • Enhanced viscosity compared to NEVANAC® Suspension for increased ocular retention1,4

These characteristics are not intended to imply superior safety or efficacy.

ONCE-DAILY POST-OP DOSING1,5

  • ILEVRO® 0.3% is the only prodrug NSAID formulated for once-daily post-op dosing1
  • 3-mL fill size ensures your patients will have enough drops for a full 17-drop course of therapy1
  • Deliver consistent dosing with our proprietary DROP-TAINER® technology1

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ILEVRO® 0.3% should be applied to the affected eye one-time-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery.1

Use of ILEVRO® 0.3% more than 1 day prior to surgery or use beyond 14 days postsurgery may increase patient risk and the severity of corneal adverse events.1

ONCE-DAILY POST-OP DOSING

A Full Course of Therapy in 17 Drops1

ILEVRO® 0.3% DOSING SCHEDULE

  • ILEVRO® 0.3% should be applied to the affected eye one‐time‐daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery.1
  • Use of ILEVRO® 0.3% more than 1 day prior to surgery or use beyond 14 days postsurgery may increase patient risk and severity of corneal adverse events. 1

PROVEN EFFICACY FOR PAIN AND INFLAMMATION MANAGEMENT ASSOCIATED WITH CATARACT SURGERY VERSUS VEHICLE1

The Only Branded Ophthalmic NSAID Tested Against an Active Comparator in Pivotal Studies1-4

PROVEN EFFICACY FOR PAIN MANAGEMENT ASSOCIATED WITH CATARACT SURGERY1

Ocular Pain Completely Resolved in 84% to 86% of Patients at Day 141,4

PERCENTAGE OF PATIENTS WITH ZERO OCULAR PAIN AT DAY 14*

*Defined as a score of zero on a pain scale from zero to five1,3

STUDY DESIGN1,4

Results from 2 randomized, multicenter, controlled, double-masked trials of adult patients undergoing cataract extraction. In Study 1, patients were randomized to receive either ILEVRO® 0.3% (n=851), NEVANAC® Suspension (n=845), ILEVRO® 0.3% vehicle (n=211), or NEVANAC® Suspension vehicle (n=213). In Study 2, patients were randomized to receive either ILEVRO® 0.3% (n=540) or ILEVRO® 0.3% vehicle (n=268).

  • In Study 1, ILEVRO® 0.3% dosed 1x daily was noninferior to NEVANAC® Suspension dosed 3x daily for inflammation clearing and resolution of ocular pain at day 14.
  • In both studies, the study drugs or vehicles were administered beginning 1 day prior to surgery, continued on the day of surgery and for 14 days thereafter.
  • Patients in the ILEVRO® 0.3% or ILEVRO® 0.3% vehicle groups received an additional drop 30 to 120 minutes prior to surgery.

PROVEN EFFICACY FOR INFLAMMATION MANAGEMENT ASSOCIATED WITH CATARACT SURGERY1

Inflammation Completely Cleared (no cells or flares)
in 61% to 65% of Patients at Day 141,4

PERCENTAGE OF PATIENTS WITH INFLAMMATION CLEARING AT DAY 14*

*Defined as zero cells/zero flare1,3

Study Design

SAFETY PROFILE

INDICATIONS AND USAGE

ILEVRO® (nepafenac ophthalmic suspension) 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.

IMPORTANT SAFETY INFORMATION

Contraindications

ILEVRO® 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs (NSAIDs).

Warnings and Precautions

  • Increased Bleeding Time – With some NSAIDs, including ILEVRO® 0.3%, there exists the potential for increased bleeding time. Ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery.
  • Delayed Healing – Topical NSAIDs, including ILEVRO® 0.3%, may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
  • Corneal Effects – Use of topical NSAIDs may result in keratitis. In some patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including ILEVRO® 0.3%, and should be closely monitored for corneal health.

Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events.

  • Contact Lens Wear – ILEVRO® 0.3% should not be administered while using contact lenses.

Adverse Reactions

The most frequently reported ocular adverse reactions following cataract surgery occurring in approximately 5% to 10% of patients were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.

Dosage and Administration

One drop of ILEVRO® 0.3% Suspension should be applied to the affected eye one-time-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery. 

For additional information about ILEVRO®, please see Full Prescribing Information.

References: 1. ILEVRO (nepafenac ophthalmic suspension) 0.3% [package insert]. Harrow IP, LLC; 2023. 2. BromSite (bromfenac ophthalmic solution) 0.075% [package insert]. Cranbury, NJ: Sun Pharma Global FZE; 2016. 3. Prolensa (bromfenac ophthalmic solution) 0.07% [package insert]. Bridgewater, NJ: Bausch & Lomb; 2016. 4. Data on file. Harrow IP, LLC; 2023. 5. NEVANAC (nepafenac ophthalmic suspension) 0.1% [package insert]. Harrow IP, LLC; 2023.

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 Read More

INDICATIONS AND USAGE

ILEVRO® (nepafenac ophthalmic suspension) 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.

IMPORTANT SAFETY INFORMATION

Contraindications

ILEVRO® 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs (NSAIDs).

Warnings and Precautions

  • Increased Bleeding Time – With some NSAIDs, including ILEVRO® 0.3%, there exists the potential for increased bleeding time. Ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery.
  • Delayed Healing – Topical NSAIDs, including ILEVRO® 0.3%, may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
  • Corneal Effects – Use of topical NSAIDs may result in keratitis. In some patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including ILEVRO® 0.3%, and should be closely monitored for corneal health.

Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events.

  • Contact Lens Wear – ILEVRO® 0.3% should not be administered while using contact lenses.

Adverse Reactions

The most frequently reported ocular adverse reactions following cataract surgery occurring in approximately 5% to 10% of patients were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.

Dosage and Administration

One drop of ILEVRO® 0.3% should be applied to the affected eye one-time-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery. 

For additional information about ILEVRO®, please see Full Prescribing Information.

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STUDY DESIGN1,4

Results from 2 randomized, multicenter, controlled, double-masked trials of adult patients undergoing cataract extraction. In Study 1, patients were randomized to receive either ILEVRO® 0.3% (n=851), NEVANAC® Suspension (n=845), ILEVRO® 0.3% vehicle (n=211), or NEVANAC® Suspension vehicle (n=213). In Study 2, patients were randomized to receive either ILEVRO® Suspension (n=540) or ILEVRO® 0.3% vehicle (n=268).

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STUDY DESIGN1,4

Results from 2 randomized, multicenter, controlled, double-masked trials of adult patients undergoing cataract extraction. In Study 1, patients were randomized to receive either ILEVRO® 0.3% (n=851), NEVANAC® Suspension (n=845), ILEVRO® 0.3% vehicle (n=211), or NEVANAC® Suspension vehicle (n=213). In Study 2, patients were randomized to receive either ILEVRO® 0.3% (n=540) or ILEVRO® 0.3% vehicle (n=268).