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Last Updated: September 21, 2021

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Claims for Patent: 9,517,220


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Summary for Patent: 9,517,220
Title:Bromfenac bioavailability
Abstract: Formulations and methods that provided enhanced bromfenac penetration into ocular tissue when topically administered, compared to the currently available BROMDAY.TM. formulation and method when topically administered. The formulations and methods did so while retaining the patient convenience of a once-daily administration and advantageously lowered the bromfenac concentration dosed to the patient.
Inventor(s): Padilla; Angel (Aliso Viejo, CA), Baklayan; George (Huntington Beach, CA)
Assignee: Bausch & Lomb Pharma Holdings Corp. (Rochester, NY)
Application Number:13/649,271
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,517,220
Patent Claims: 1. A method for treating an ocular condition in a patient in need thereof with bromfenac, the method comprising administering bromfenac as the only active 0.07% w/v in a composition at a pH.gtoreq.6.0 and pH<8.0 and containing 1.0% povidone, topically to the eye of the patient, enhancing bromfenac penetration into ocular tissue to provide the same or better therapy than a higher bromfenac concentration.

2. The method of claim 1 wherein the bromfenac formulation is at pH.gtoreq.7.0 and .ltoreq.7.8.

3. The method of claim 1 wherein the bromfenac formulation contains 0.07% bromfenac and is at pH 7.0.

4. The method of claim 1 wherein the bromfenac formulation contains 0.07% bromfenac and is at pH 7.1.

5. The method of claim 1 wherein the bromfenac formulation contains 0.07% bromfenac and is at pH 7.2.

6. The method of claim 1 wherein the bromfenac formulation contains 0.07% bromfenac and is at pH 7.3.

7. The method of claim 1 wherein the bromfenac formulation contains 0.07% bromfenac and is at pH 7.4.

8. The method of claim 1 wherein the bromfenac formulation contains 0.07% bromfenac and is at pH 7.5.

9. The method of claim 1 wherein the bromfenac formulation further comprises at least one of tyloxapol, sodium sulfite, and benzalkonium chloride.

10. The method of claim 1 wherein the bromfenac formulation further comprises at least one of tyloxapol at a concentration of 0.01% to 0.5%, sodium sulfite, or benzalkonium chloride at a concentration of .ltoreq.0.01%.

11. The method of claim 1 wherein the ocular condition is selected from the group consisting of meibomianitis, blepharitis, uveitis, iritis, conjunctival hyperemia, eyelid hyperemia, keratitis, ocular rosacea, scleritis, wet age related macular degeneration, diabetic retinopathy, diabetic macular edema, central retinal vein occlusion, branch retinal vein occlusion, anterior chamber inflammation, allergic conjunctivitis, conjunctivitis, surgical trauma, dry eye, viral conjunctivitis, bacterial conjunctivitis, anterior uveitis, penetration from a foreign body, burns (chemical, radiation, or thermal), and combinations thereof.

12. The method of claim 1 wherein administration is to a post-cataract surgery patient and treats post-cataract surgery pain, post-surgery inflammation, or both in the patient.

13. The method of claim 1 wherein administration is once daily prior to surgery performed on the patient and continues once daily through day 14 after said surgery.

14. The method of claim 1 wherein the ocular condition is an ocular inflammatory condition.

15. The method of claim 1 wherein administration is as needed.

16. The method of claim 1 resulting in enhanced bromfenac bioavailability in an ocular tissue in the anterior segment of the eye.

17. The method of claim 1 resulting in enhanced bromfenac bioavailability in an ocular tissue in the back of the eye.

18. The method of claim 1 wherein the concentration of bromfenac at 0.07% w/v is used without having to concurrently increase the frequency of dosing to achieve the same or better efficacy as a composition containing 0.09% w/v of bromfenac at pH 8.3.

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