DESCRIPTION SECTION

11 DESCRIPTION

Bromfenac ophthalmic solution 0.07 % is a sterile, topical, nonsteroidal anti- inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution 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 molecular 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. Bromfenac ophthalmic solution, 0.07 % is supplied as a sterile aqueous 0.07 % solution, with a pH of 7.55 to 8.15. The osmolality of bromfenac ophthalmic solution, 0.07 % is approximately 280 to 340 mOsmol/kg.

Each mL of bromfenac ophthalmic solution, 0.07 % contains:

Active: Each mL contains bromfenac sodium sesquihydrate 0.0805 %, which is equivalent to bromfenac free acid 0.07 %.

Preservative: benzalkonium chloride 0.005 %

Inactives: boric acid, edetate disodium (dihydrate), povidone, sodium borate, sodium sulfite, sodium hydroxide to adjust pH, tyloxapol and water for injection USP.

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INDICATIONS & USAGE SECTION

Highlight: Bromfenac ophthalmic solution 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)

1 INDICATIONS AND USAGE

Bromfenac ophthalmic solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

DOSAGE & ADMINISTRATION SECTION

Highlight: 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 post- surgery. (2.1)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

One drop of bromfenac ophthalmic solution should be applied 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

Bromfenac ophthalmic solution 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.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Topical ophthalmic solution: bromfenac 0.07 % (3)

3 DOSAGE FORMS AND STRENGTHS

Topical ophthalmic solution: bromfenac 0.07 %

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CONTRAINDICATIONS SECTION

Highlight: None (4)

4 CONTRAINDICATIONS

None

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USE IN SPECIFIC POPULATIONS SECTION

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic exposure) produced no treatment-related malformations in reproduction studies. However, embryo-fetal lethality and maternal toxicity were produced in rats and rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human exposure), and caused dystocia, increased neonatal mortality and reduced postnatal growth at 0.9 mg/kg/day.

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided.

8.3 Nursing Mothers

Caution should be exercised when bromfenac ophthalmic solution is administered to a nursing woman.

8.4 Pediatric Use

Safety and efficacy in pediatric patients below the age of 18 years have not been established.

8.5 Geriatric Use

There is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 70 years of age and older compared to younger adult patients.

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ADVERSE REACTIONS SECTION

Highlight: The most commonly reported adverse reactions in 3 to 8 % of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and vision blurred.(6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or****www.fda.gov/medwatch

6 ADVERSE REACTIONS

6.1 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 bromfenac ophthalmic solution 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.

CLINICAL STUDIES SECTION

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 post- surgery 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.

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SPL UNCLASSIFIED SECTION

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) – 454 775

India

Revised: August 2023 ID:240350

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