Alcon Launches ILEVRO™ (nepafenac ophthalmic suspension) 0.3%, a New Non-Steroidal Anti-Inflammatory Drug, for the Treatment of Pain and Inflammation Associated with Cataract Surgery
Jan 21, 2013
ILEVRO™ Suspension demonstrated superior clinical efficacy compared to its vehicle in treating postoperative pain and inflammation
ILEVRO™ Suspension offers once-daily dosing post cataract surgery
January 21, 2013–Alcon, the global leader in eye care, today announced the launch of ILEVRO™Suspension, a new once-daily treatment option for pain and inflammation associated with cataract surgery. In two double masked, randomized clinical trials, ILEVRO™ Suspension demonstrated superior clinical efficacy compared to its vehicle.
In the studies, patients treated with ILEVRO™Suspension were less likely to have ocular pain and measurable signs of inflammation (cells and flare) at the end of treatment than those treated with its vehicle.
“We are committed to developing products that continue to improve patient care,” said Gary Menichini, Vice President and General Manager, U.S. Pharmaceuticals. “This launch represents the dedication of the R&D team to engineer an efficacious, innovative formulation with a reduced dosing regimen.”
Patients administered ILEVRO™Suspension experienced superior outcomes when compared to those on vehicle in the following areas:
Inflammation resolved at day 14 in 65 percent of ILEVRO™Suspension patients vs. 32 percent of patients on vehicle
Pain resolution rates in ILEVRO™Suspension treated patients were 86 percent compared to 46 percent of patients on vehicle
The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients.
“Effective management of pain and inflammation associated with cataract surgery is a priority for me,” said Stephen Lane, MD. “I am confident that this highly effective option, with its innovative formulation, will benefit my patients.”
For more information on ILEVRO™Suspension visit alcon.com and refer to accompanying full prescribing information.
About Alcon Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group with pro-forma sales of USD 10 billion in 2011. Headquartered in Fort Worth, Texas, USA, Alcon has 24,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.
Media Inquiries Sandra Waite 817-615-5092 (office) 678-371-9457 (mobile) [email protected]
INDICATIONS AND USAGE ILEVRO™ Suspension is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.
Dosage and Administration One drop of ILEVRO™ 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. Use with Other Topical Ophthalmic Medications ILEVRO™ Suspension may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. IMPORTANT SAFETY INFORMATION Contraindications ILEVRO™ Suspension is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDs. Warnings and Precautions
Increased Bleeding Time- With some nonsteroidal anti-inflammatory drugs including ILEVRO™ Suspension, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery.
It is recommended that ILEVRO™ Suspension be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Delayed Healing- Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including ILEVRO™ Suspension, may slow or delay healing. Topical corticosteroids are also known to 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 susceptible 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™ Suspension and should be closely monitored for corneal health.
Postmarketing experience with topical NSAIDs suggests that 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. Postmarketing experience with topical NSAIDs also suggests that 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™ Suspension should not be administered while using contact lenses.
Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these reactions may be the consequence of the cataract surgical procedure. Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis.
For additional information aboutILEVRO™ Suspension, please refer to the accompanying full prescribing information.