HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information needed to use
`PROLENSA safely and effectively. See full prescribing information for
`PROLENSA.
`
`PROLENSA® (bromfenac ophthalmic solution) 0.07%,
`for topical ophthalmic use
`Initial U.S. Approval: 1997
`
`----------------------- WARNINGS AND PRECAUTIONS -----------------------
`• Sulfite Allergic Reactions (5.1)
`• Slow or Delayed Healing (5.2)
`• Potential for Cross-Sensitivity (5.3)
`• Increased Bleeding Time (5.4)
`• Keratitis and Corneal Reactions (5.5)
`
`--------------------------- INDICATIONS AND USAGE ---------------------------
`PROLENSA 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. (1)
`
`------------------------------ ADVERSE REACTIONS ------------------------------
`The most commonly reported adverse reactions in 3% to 8%of patients were
`anterior chamber inflammation, foreign body sensation, eye pain,
`photophobia, and blurred vision. (6.1)
`
`---------------------- DOSAGE AND ADMINISTRATION ----------------------
`Instill one drop into the affected eye once daily beginning 1 day prior to
`surgery, continued on the day of surgery, and through the first 14 days
`postsurgery. (2.1)
`
`--------------------- DOSAGE FORMS AND STRENGTHS ---------------------
`Ophthalmic solution: bromfenac 0.07% (3)
`
`----------------------------- CONTRAINDICATIONS -----------------------------
`None. (4)
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`1
`INDICATIONS AND USAGE
`2
`DOSAGE AND ADMINISTRATION
`2.1 Recommended Dosage
`2.2 Use with Other Topical Ophthalmic Medications
`DOSAGE FORMS AND STRENGTHS
`3
`CONTRAINDICATIONS
`4
`5 WARNINGS AND PRECAUTIONS
`5.1 Sulfite Allergic Reactions
`5.2 Slow or Delayed Healing
`5.3 Potential for Cross-Sensitivity
`5.4 Increased Bleeding Time
`5.5 Keratitis and Corneal Reactions
`5.6 Risk of Contamination
`5.7 Contact Lens Wear
`ADVERSE REACTIONS
`6.1 Clinical Trials Experience
`
`6
`
`To report SUSPECTED ADVERSE REACTIONS, contact Bausch &
`Lomb Incorporated, at 1-800-553-5340 or FDA at 1-800-FDA-1088 or
`www.fda.gov/medwatch.
`
`See 17 for PATIENT COUNSELING INFORMATION.
`
`Revised: 2/2025
`
`8
`
`USE IN SPECIFIC POPULATIONS
`8.1 Pregnancy
`8.2 Lactation
`8.4 Pediatric Use
`8.5 Geriatric Use
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`12.3 Pharmacokinetics
`13 NONCLINICAL TOXICOLOGY
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`14 CLINICAL STUDIES
`14.1 Ocular Inflammation and Pain
`16 HOW SUPPLIED/STORAGE AND HANDLING
`17
`PATIENT COUNSELING INFORMATION
`*Sections or subsections omitted from the full prescribing information
`are not listed.
`
`Reference ID: 5532951
`
`

`

`FULL PRESCRIBING INFORMATION
`
`1 INDICATIONS AND USAGE
`
`PROLENSA® is indicated for the treatment of postoperative inflammation and reduction of ocular pain in
`patients who have undergone cataract surgery.
`
`2 DOSAGE AND ADMINISTRATION
`
`2.1 Recommended Dosage
`Apply one drop to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of
`surgery, and through the first 14 days of the postoperative period.
`
`2.2 Use with Other Topical Ophthalmic Medications
`PROLENSA may be administered in conjunction with other topical ophthalmic medications such as alpha
`agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be
`administered at least 5 minutes apart.
`
`3 DOSAGE FORMS AND STRENGTHS
`
`Ophthalmic solution: bromfenac 0.07%
`
`4 CONTRAINDICATIONS
`
`None.
`
`5 WARNINGS AND PRECAUTIONS
`
`5.1 Sulfite Allergic Reactions
`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.
`
`5.2 Slow or Delayed Healing
`All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, 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.
`
`5.3 Potential for Cross-Sensitivity
`There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other
`NSAIDs, including bromfenac. Therefore, caution should be used when treating individuals who have
`previously exhibited sensitivities to these drugs.
`
`Reference ID: 5532951
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`

`

`5.4 Increased Bleeding Time
`With some NSAIDs, including bromfenac, there exists the potential for increased bleeding time due to
`interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause
`increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
`
`It is recommended that PROLENSA ophthalmic solution be used with caution in patients with known bleeding
`tendencies or who are receiving other medications which may prolong bleeding time.
`
`5.5 Keratitis and Corneal Reactions
`Use of topical NSAIDs, including bromfenac, 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 bromfenac, 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 24 hours prior to surgery or
`use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse
`events.
`
`5.6 Risk of Contamination
`Do not touch dropper tip to the eye, eyelids, or to any surface, as this may contaminate the contents. Replace the
`bottle cap after using.
`
`5.7 Contact Lens Wear
`PROLENSA should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of
`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.
`
`6 ADVERSE REACTIONS
`
`6.1 Clinical Trials 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 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.
`
`Reference ID: 5532951
`
`

`

`8 USE IN SPECIFIC POPULATIONS
`
`8.1 Pregnancy
`Risk Summary
`
`There are no available data on PROLENSA use in pregnant women to evaluate a drug-associated risk of major
`birth defects, miscarriage or other adverse maternal or fetal outcomes.
`
`The systemic exposure to bromfenac following topical ocular administration is low [see Clinical Pharmacology
`(12.3)]. Consequently, the systemic exposure of a pregnant woman to bromfenac is expected to be minimal
`following topical ocular administration.
`
`However, because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal
`cardiovascular system (closure of ductus arteriosus), the use of PROLENSA during late pregnancy should be
`avoided.
`
`The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
`All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general
`population, the estimated background risk of major birth defects and miscarriage in clinically recognized
`pregnancies is 2% to 4% and 15% to 20%, respectively.
`
`Clinical Considerations
`
`Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and
`injectable NSAIDs. Measurable maternal and fetal plasma drug levels are available with oral and injectable
`routes of NSAID administration. The maternal plasma level of PROLENSA following ocular administration is
`unknown [see Clinical Pharmacology (12.3)].
`
`Data
`
`Animal Data
`
`Embryo-fetal lethality and maternal toxicity were produced in rats and rabbits treated with bromfenac during
`the period of organogenesis at oral doses up to 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. These doses
`corresponded to a Cmax 90- and 150- times the predicted Cmax at the recommended human ophthalmic dose
`(RHOD), respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the
`predicted human Cmax at the RHOD), and caused dystocia, increased neonatal mortality, and reduced postnatal
`growth at 0.9 mg/kg/day (90 times the predicted human Cmax at the RHOD).
`
`8.2 Lactation
`There are no data on the presence of bromfenac in human milk, the effects on the breastfed infant, or the effects
`on milk production.
`
`The systemic exposure of a breastfeeding woman to bromfenac is expected to be minimal following topical
`ocular administration, however, the possibility of harm to the breastfed infant cannot be ruled out.
`
`Reference ID: 5532951
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`The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical
`need for PROLENSA, and any potential adverse effects on the breastfed infant from PROLENSA or from the
`underlying maternal conditions.
`
`8.4 Pediatric Use
`The safety and effectiveness of PROLENSA have not been established in pediatric patients.
`
`8.5 Geriatric Use
`No overall differences in safety or effectiveness of PROLENSA have been observed between patients 70 years
`of age and older and younger adult patients.
`
`11 DESCRIPTION
`
`PROLENSA (bromfenac ophthalmic solution) 0.07% is a sterile, nonsteroidal anti-inflammatory drug (NSAID)
`for topical ophthalmic use. Each mL of PROLENSA contains 0.805 mg bromfenac sodium sesquihydrate
`(equivalent to 0.7 mg bromfenac free acid). The USAN name for bromfenac sodium sesquihydrate is bromfenac
`sodium. Bromfenac sodium is designated chemically as sodium [2-amino-3-(4-bromobenzoyl) phenyl] acetate
`sesquihydrate, with an empirical formula of C15H11BrNNaO3• 1½H2O. The chemical structure for bromfenac
`sodium sesquihydrate is:
`
`Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is
`383.17. PROLENSA ophthalmic solution is supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The
`osmolality of PROLENSA ophthalmic solution is approximately 300 mOsmol/kg.
`
`Each mL of PROLENSA ophthalmic solution contains:
`
`Active: Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free
`acid 0.07%.
`
`Inactives: boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide
`to adjust pH, and water for injection, USP.
`
`Preservative: benzalkonium chloride 0.005%
`
`12 CLINICAL PHARMACOLOGY
`
`12.1 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
`
`Reference ID: 5532951
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`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.
`
`12.3 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.
`
`13 NONCLINICAL TOXICOLOGY
`
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`
`Carcinogenesis
`Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day
`(systemic exposure 30 times the systemic exposure predicted from RHOD assuming the human systemic
`concentration is at the limit of quantification) and 5 mg/kg/day (340 times the predicted human systemic
`exposure), respectively, revealed no significant increases in tumor incidence.
`
`Mutagenesis
`Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation,
`chromosomal aberration, and micronucleus tests.
`
`Impairment of Fertility
`Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9
`mg/kg/day and 0.3 mg/kg/day, respectively (systemic exposure 90 and 30 times the predicted human exposure,
`respectively).
`
`14 CLINICAL STUDIES
`
`14.1 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.
`
`Reference ID: 5532951
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`

`

`Proportion of Subjects with Cleared Ocular Inflammation (0 cell and no flare)
`Study
`Visit
`Bromfenac 0.07%
`Vehicle
`
`7/108
`(6.5%)
`14/108
`(13.0%)
`14/110
`(12.7%)
`30/110
`(27.3%)
`
`Vehicle
`
`47/108
`(43.5%)
`61/110
`(55.5%)
`
`Difference (%)
`(Asymptotic 95% CI)
`17.6
`(8.4, 26.8)
`32.5
`(21.4, 43.8)
`17.3
`(6.7, 27.9)
`18.2
` (5.7, 30.7)
`
`Difference (%)
`(Asymptotic 95% CI)
`37.7
`(25.9, 49.6)
`20.9
`(8.7, 33.1)
`
`Study 1
`
`At Day 8
`
`At Day 15
`
`Study 2
`
`At Day 8
`
`27/112
`(24.1%)
`51/112
`(45.5%)
`33/110
`(30.0%)
`50/110
`(45.5%)
`Proportion of Subjects Who Were Pain Free
`Study
`Visit
`Bromfenac 0.07%
`
`At Day 15
`
`Study 1
`
`At Day 1
`
`Study 2
`
`At Day 1
`
`91/112
`(81.3%)
`84/110
`(76.4%)
`
`16 HOW SUPPLIED/STORAGE AND HANDLING
`
`PROLENSA® (bromfenac ophthalmic solution) 0.07% is supplied in a white LDPE plastic squeeze bottle with a
`15 mm LDPE white dropper tip and 15 mm polypropylene gray cap as follows:
`
`• NDC 24208-602-03
`
`3 mL in a 7.5 mL bottle
`
`Storage
`Store at 15ºC to 25ºC (59ºF to 77ºF). After opening, PROLENSA can be used until the expiration date on the
`bottle.
`
`17 PATIENT COUNSELING INFORMATION
`
`Slow or Delayed Healing
`Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs.
`
`Risk of Contamination
`Advise patients to not touch dropper tip to the eye, eyelids, or to any surface, as this may contaminate the
`contents. Advise patients to replace bottle cap after using.
`
`Contact Lens Wear
`Advise patients to remove contact lenses prior to instillation of 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.
`
`Reference ID: 5532951
`
`

`

`Use with Other Topical Ophthalmic Medications
`Advise patients that if more than one topical ophthalmic medication is being used, the medicines should be
`administered at least 5 minutes apart.
`
`Manufactured by:
`Bausch & Lomb Americas Inc.
`Bridgewater, NJ 08807 USA
`
`Under License From:
`Senju Pharmaceutical Co., Ltd.
`Osaka, Japan 541-0046
`
`Patented. See https://patents.bausch.com for US patent information.
`
`PROLENSA is a trademark of Bausch & Lomb Incorporated or its affiliates.
`
`Update p/ns
`
`Reference ID: 5532951
`
`