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(12) Patent Application Publication (10) Pub. No.: US 2006/0183698 A1 Abelson (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2006/0183698 A1 Abelson (43) Pub US 2006O183698A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0183698 A1 Abelson (43) Pub. Date: Aug. 17, 2006 (54) OPHTHALMC FORMULATIONS AND USES Publication Classification THEREOF (51) Int. Cl. A61K 3 1/7034 (2006.01) (75) Inventor: Mark Abelson, Andover, MA (US) A 6LX 3/573 (2006.01) A6II 3L/496 (2006.01) Correspondence Address: A 6LX 3L/95 (2006.01) TOWNSEND AND TOWNSEND AND CREW, (52) U.S. Cl. ...................... 514/35: 514/253.08: 514/171; LLP 514/563; 514/200 TWO EMBARCADERO CENTER (57) ABSTRACT EIGHTH FLOOR Provided by the present invention are compositions or SAN FRANCISCO, CA 94111-3834 (US) formulations suitable for application to a patient's eyes which utilizes a topical ophthalmically-acceptable formula tion comprising a therapeutically-effective amount of an (73) Assignee: ISTA Pharmaceuticals, Inc., Irvine, CA ophthalmically-active antimicrobial agent, and an oph Appl. No.: 11/146,652 thalmically-active anti-inflammatory or steroidal agent in (21) combination with physiologic levels of serum electrolytes in (22) Filed: Jun. 7, 2005 an ophthalmic formulation for the treatment of changes in the normal eye condition. The invention also includes meth Related U.S. Application Data ods of treating patients having an ophthalmic disease, injury or disorder, utilizing the compositions or formula (60) Provisional application No. 60/675,179, filed on Apr. tions. Also provided are kits comprising the compositions or 26, 2005. Provisional application No. 60/577.567, formulations and a means of applying the compositions or filed on Jun. 7, 2004. formulation to the patient's eyes. US 2006/0183698 A1 Aug. 17, 2006 OPHTHALMC FORMULATIONS AND USES from about 14.592 to about 24.32 mg/L. phosphate in a THEREOF concentration from about 85 to about 150 mg/L, and bicar bonate in a concentration from about 1281 to about 2013 CROSS-REFERENCES TO RELATED mg/L. APPLICATIONS 0006 The antimicrobial agent, and anti-inflammatory or 0001. This application claims benefit of priority from steroidal agent of the composition or formulation are used to U.S. Provisional Patent Application 60/577.567, filed Jun. 7, treat or mitigate the injury, disease or disorder. One steroidal 2004, and from U.S. Provisional Patent Application 60/675, agent contemplated in the present invention is prednisolone 179, filed Apr. 26, 2005 both of which are hereby incorpo whereas a contemplated antimicrobial is tobramycin. rated in their entirety as if fully set forth. 0007. The invention also includes methods of treating patient's having an ophthalmic disease, injury or disorder, BACKGROUND OF THE INVENTION utilizing the compositions or formulations. Further, the 0002 The present invention relates to ophthalmic formu compositions or formulations can be utilized to restore the lations, kits and uses thereof, wherein the formulations normal condition of the eye when the normal condition has utilize physiologic levels of serum electrolytes in conjunc been disrupted or changed. Also provided are kits compris tion with pharmacologically effective doses of an antimi ing the compositions or formulations and a means of apply crobial agent, and an anti-inflammatory or steroidal agent in ing the compositions or formulation to the patient’s eyes. a single formulation for the treatment of ocular disorders, diseases or injuries. Combinations or formulations contain DESCRIPTION OF THE INVENTION ing an antimicrobial agent and an anti-inflammatory agent are available in the ophthalmic art. However, there are 0008. Without being bound by a particular theory, it concerns and expressed reservations in the ophthalmic com appears that the physiology of the injured or diseased eye munity about the safety and efficacy of such prior art more closely resembles the physiology of serum due to the combinations. There continues to be a need for an effective release of vessel contents into the tear film and, as such, the and safe topical ophthalmic pharmaceutical composition of contents are pathological to the condition of the eye. There a steroid or anti-inflammatory agent and a broad spectrum fore, the application of an ophthalmic formulation that antibiotic which, when administered to the eye will not mimics the injured eye condition is a focus of the present inhibit the activity of the antibiotic, or steroidal or anti invention, since the application of Such a formulation does inflammatory components. not shock the already overly-sensitized tissues and is able to gradually restore the eye to a normal condition (i.e. non 0003. Many ophthalmic conditions result in an aberrant inflamed and non-infected State). Such an approach is coun tear film composition. The electrolyte balances and concen terintuitive to conventional therapies, since physicians pres trations in tears can change as a result of a disruption in the ently would not use a formulation that continues the normal eye physiology. For example, when ocular tissue is pathologic condition within the eye. Nevertheless, it is inflamed, serum components leak from the vasculature into important to consider that the addition of a formulation with the tear film. Many of these ophthalmic conditions are electrolytes in “equilibrium' with the electrolytes in the typically treated with antimicrobial and/or steroidal or anti “inflamed eye may provide several advantages when used inflammatory compounds. in conjunction with an antimicrobial and a steroidal or anti-inflammatory agent. Such advantages could include, but SUMMARY OF THE INVENTION are not necessarily limited to, a formulation that is more 0004 The present invention comprises a formulation comfortable to the patient which may result in better patient which mimics the serum components of the injured eye compliance and/or a formulation that promotes faster heal (instead of the normal eye tear physiology) which when used 1ng. in conjunction with an antimicrobial, and anti-inflammatory or steroidal agent in a single formulation assist in restoring DEFINITIONS the injured eye to its normal condition (i.e., non-inflamed 0009 “Ophthalmically-acceptable” means that the for and non-infected State). mulation, active agent, excipient or other material is com 0005 The present invention utilizes physiologic levels of patible with ocular tissue; that is, it does not cause signifi various serum electrolytes in an ophthalmic composition or cant or undue detrimental effects when brought into contact formulation also containing an antimicrobial agent, and an with ocular tissue. In some instances, actives and/or excipi anti-inflammatory or steroidal agent for the treatment of ents of the formulation may cause Some discomfort or various ophthalmic injuries, diseases or disorders. Typically, stinging in the eye; however, those excipients are still the injury, disease or disorder results in an inflammatory considered ophthalmically-acceptable for the purposes of response in and around the eye and/or causes leakage of the this application. In many instances, these irritating compo blood vessels in the eye. The serum electrolytes include nents are removed from the formulations for comfort of the Sodium, potassium, chloride, calcium, magnesium, phos patient. For example, polyvinyl alcohol (PVA) can be elimi phate, and/or bicarbonate in concentrations to match the nated from the formulation ingredients. normal physiologic levels. These levels comprise Sodium in 0010) “Antimicrobial compound' includes those that a concentration from about 3105 to about 3358 mg/L.; effectively kill or mitigate the activity of a microbe. Anti potassium in a concentration from about 136.85 to about microbial includes antibacterial, bacteriostatic, and the like. 207.23 mg/L. chloride in a concentration from about 3368.7 These agents include, but are not limited to: azithromycin, to about 3829.68 mg/L.; calcium in a concentration from tobramycin, gentamicin, ciprofloxacin, norfloxacin, ofloxa about 85 to about 103 mg/L, magnesium in a concentration cin, and sparfloxacin. US 2006/0183698 A1 Aug. 17, 2006 0.011) “Immunosuppressive agent,” and “immunosup the amount of light entering the eye, impairing vision. pressive drug.” refers to any agent which inhibits or prevents Corneal opacification can occur as a result of bacterial, an immune response. Exemplary agents include, but are not fungal or viral infections, or from trauma to the eye. limited to: dexamethasone, cyclosporin A. azathioprine, brequinar, gusperimus, 6-mercaptopurine, mizoribine, rapa 0021 “Diabetic retinopathy' is a complication of diabe mycin, tacrolimus (FK-506), folic acid analogs (e.g. denop tes typically classified into two stages, Non-Proliferative terin, edatrexate, methotrexate, piritrexim, pteropterin, Diabetic Retinopathy (NPDR) and Proliferative Diabetic TomudeX(R), trimetrexate), purine analogs (e.g., cladribine, Retinopathy (PDR). fludarabine, 6-mercaptopurine, thiamiprine, thiaguanine), pyrimidine analogs (e.g., ancitabine, azacitidine, 6-azauri 0022 “Non-Proliferative Diabetic Retinopathy” (NPDR) dine, carmofur, cytarabine, doxifluridine, emitefur, enocit is a complication of diabetes in the early stage of diabetic abine, floXuridine, fluorouracil, gemcitabine, tegafur), fluo retinopathy that occurs when normal blood vessels in the cinolone, triamcinolone, anecortaVe acetate, retina are damaged due to diabetes and Swell and begin to flurometholone, medrysone, and prednisilone. leak fluid and small amounts of blood into the eye. 0012 “Nutrient sugar means any sugar that can provide nutrients to cells. Serum Electrolytes
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