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RAPID REDUCTION OF INFLAMMATION AT DAYS 8 AND 15 VS VEHICLE1

In the same study, significant inflammation reduction was reported as early as Day 3

INFLAMMATION CLEARANCE AT DAY 151,2,4

Additional prespecified endpoint

Zero to trace cells†

Primary endpoint

Complete clearance of cells and flare*

Study design: Clinical efficacy evaluated in 2 randomized, double-masked, vehicle-controlled trials of patients undergoing cataract surgery. Each randomized patient received PROLENSA® or vehicle starting with one drop into the surgical eye the day prior to and the day of surgery, and for 14 days post-surgery. Study endpoints were clearing of ocular inflammation (SOIS=0) by Day 15 (primary) and the number of subjects pain free on Day 1 after surgery (secondary).1,2

*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 (0 cells and absence of flare).5

†0-5 cells.

PAIN FREE AT DAY 12,4

  • 78.8% vs 49.5% with vehicle; P<0.0001
  • One dose given on the day of surgery‖
  • Only 3% of patients treated with PROLENSA® discontinued by Day 15 due to lack of efficacy vs 24% with vehicle2

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

Ocular pain was evaluated by the Ocular Comfort Grading Assessment.2

Powered for Ocular Comfort

 

Indications and usage

PROLENSA® (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Important Safety Information

  • PROLENSA® contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
  • All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
  • There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Use with caution in patients who have previously exhibited sensitivities to these drugs.
  • There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. Use with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
  • Use of topical NSAIDs may result in keratitis. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, 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. Post-marketing experience with topical NSAIDs suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
  • PROLENSA® should not be instilled while wearing contact lenses. The preservative in PROLENSA®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA®.
  • The most commonly reported adverse reactions in 3%-8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.

Click here for full Prescribing Information for PROLENSA®.

References: 1. 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. 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. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. Accessed July 9, 2018. 4. PROLENSA Prescribing Information. 5. Data on file, Bausch & Lomb Incorporated.

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