Prolensa

Name: Prolensa

Warnings

Contraindications

None listed by manufacturer

Cautions

Contains sodium sulfite which may cause allergic reactions in susceptible individuals NSAIDs may slow or delay healing

Potential for cross-sensitivity to other NSAIDs or aspirin

Interferes with platelet aggregation and may increase bleeding of ocular tissues; use caution in patients with predisposition to bleeding

Corneal effects, including keratitis, reported Remove contact lenses before application, may reinsert 10 minutes after instilling drops

Corneal adverse reactions may occur in patients with keratitis after continued use that may result in loss of vision; discontinue use in patients with evidence of corneal epithelial damage

Use caution in patients with diabetes (may be at risk of corneal adverse effects that may result in loss of vision)

Use caution in patients with complicated ocular surgeries, corneal denervation, repeat ocular surface disease, or corneal epithelial defects

Use caution in patients with rheumatoid arthritis

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Side effects

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most commonly reported adverse reactions following use of PROLENSA following cataract surgery include: anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and vision blurred. These reactions were reported in 3 to 8% of patients.

Read the entire FDA prescribing information for Prolensa (Bromfenac Ophthalmic Solution)

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Prolensa Overview

Prolensa is a prescription medication used to treat eye inflammation and eye pain in patients who have undergone cataract surgery. Prolensa belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release of certain natural substances that cause pain and swelling.

This medication comes in the form of an eye drop to be given once a day beginning the day before cataract surgery, on the day of surgery, and for 14 days after surgery.

Common side effects in clinical trials include eye pain, eye discomfort in bright light, blurred vision, and the feeling of "something in the eye" (foreign body sensation).

Inform MD

Before taking Prolensa, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • have a sulfa allergy
  • have had an allergic reaction to this medication before, to any other NSAID, or to aspirin (Ecotrin)
  • have eye defects, damage, or dysfunction
  • have rheumatoid arthritis
  • have or have had other recent ocular surgeries
  • have diabetes
  • take blood thinners
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

 

Prolensa Usage

Use Prolensa exactly as prescribed.

This medication is to be given once a day starting on the day before cataract surgery, on the day of surgery, and for 14 days after surgery.

Prolensa may be given along with other ophthalmic (eye) medications. Drops of each medication prescribed should be given at least 5 minutes apart.

Prolensa should not be given while wearing contact lenses. Remove contact lenses before using Prolensa. The preservative in Prolensa may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Prolensa.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Prolensa at the same time.

Commonly used brand name(s)

In the U.S.

  • Bromday
  • Bromsite
  • Prolensa
  • Xibrom

Available Dosage Forms:

  • Solution

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Prolensa or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prolensa. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Prolensa - Clinical Pharmacology

Mechanism of Action

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase (COX) 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Pharmacokinetics

The plasma concentration of bromfenac following ocular administration of Prolensa (bromfenac ophthalmic solution) 0.07% in humans is unknown. Based on the maximum proposed dose of one drop to each eye (0.035 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

Clinical Studies

Ocular Inflammation and Pain

Bromfenac 0.07% QD for the treatment of postoperative inflammation and reduction of ocular pain was evaluated in two multi-center, randomized, double-masked, parallel-group, and placebo (vehicle)-controlled studies. Patients undergoing cataract surgery self-administered bromfenac 0.07% or vehicle once daily, beginning 1 day prior to surgery, continuing on the morning of surgery and for 14 days after surgery.  Complete clearance of ocular inflammation (0 cell and no flare) was assessed on Days 1, 3, 8, and 15 postsurgery using slit lamp biomicroscopy. The pain score was self-reported. The primary efficacy endpoint was the proportion of subjects who had complete clearance of ocular inflammation by Day 15. In the intent-to-treat analyses from both assessments, complete clearance at Day 8 and Day 15, bromfenac 0.07% was superior to vehicle as shown in the following table.

Proportion of Subjects with Cleared Ocular Inflammation (0 cells and no flare)

Study

Visit

Bromfenac 0.07%

Vehicle

Difference (%)

(Asymptotic 95% CI)

Study 1

At Day 8

27/112 (24.1%)

7/108 (6.5%)

17.6 (8.4, 26.8)

At Day 15

51/112 (45.5%)

14/108 (13.0%)

32.5 (21.4, 43.8)

Study 2

At Day 8

33/110 (30.0%)

14/110 (12.7%)

17.3 (6.7, 27.9)

At Day 15

50/110 (45.5%)

30/110 (27.3%)

18.2 (5.7, 30.7)

Proportion of Subjects Who Were Pain Free

Study

Visit

Bromfenac 0.07%

Vehicle

Difference (%)

(Asymptotic 95% CI)

Study 1

At Day 1

91/112 (81.3%)

47/108 (43.5%)

37.7 (25.9, 49.6)

Study 2

At Day 1

84/110 (76.4%)

61/110 (55.5%)

20.9 (8.7, 33.1)

(web3)