PROLENSA (bromfenac ophthalmic solution) 0.07%



                                                  Important Safety Information






   Treats inflammation and pain after cataract surgery
   Established safety profile
   No shaking required
   Consistent dose in each drop
   No generic equivalent


Inflammation control Pain control


In clinical studies with PROLENSA, more than 2x as many patients had complete clearance of inflammation vs placebo 15 days after surgery

  • Rapid reduction of inflammation as early as 8 days after surgery3
  • Individual results may vary

Approximately 4 of 5 patients were pain
free 1 day after surgery


  • 78.8% of patients were pain free 1 day after surgery vs only 49.5% with placebo1,2
  • Individual results may vary

*Ocular inflammation was assessed by the Summed Ocular Inflammation Score (SOIS). Complete clearance of inflammation was defined as the proportion of patients who achieved an SOIS of grade 0. Ocular pain was evaluated by the Ocular Comfort Grading Assessment.4

†Dosing: One drop per day starting at 1 day prior to surgery, continued on the day of surgery, and through the first 14 days after surgery.2



What to do after cataract surgery ››

INDICATION AND USAGE

PROLENSA (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated to treat inflammation and reduce eye pain in patients after cataract surgery.

IMPORTANT SAFETY INFORMATION ABOUT PROLENSA

  • PROLENSA contains sodium sulfite, a substance that may cause allergic reactions, some severe, in certain people. In addition, tell your doctor if you have had an allergic reaction to any other medications.

  • Slow or delayed healing may occur while using non-steroidal anti-inflammatory drugs (NSAIDs) such as PROLENSA.

  • Use of NSAIDs in the eye may result in certain serious eye conditions that can be sight threatening. Tell your doctor immediately about any side effect that you may have.

  • Replace bottle cap after using and do not touch dropper tip to any surface in order to avoid contamination of the bottle.

  • Remove contact lenses prior to using PROLENSA. The preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA.

  • If more than one eye medicine is being used, use the eye medicines at least 5 minutes apart.

  • The most common side effects (seen in 3%-8% of patients) were inflammation of the eye, foreign body sensation, eye pain, light sensitivity, and blurred vision.

Please click here for full Prescribing Information about PROLENSA.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.

References 1. PROLENSA Prescribing Information. 2. Walters TR, Goldberg DF, Peace JH, Gow JA; for the Bromfenac Ophthalmic Solution 0.07% Once Daily Study Group. Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery: results of 2 randomized controlled trials. Ophthalmology. 2014;121(1):25-33. 3. Silverstein SM, Jackson MA, Goldberg DF, Muñoz M. The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery. Clin Ophthalmol. 2014;8:965-972. 4. Data on file, Bausch & Lomb Incorporated.

PRA.0022.USA.17