CHIMERIC CYTOKINE FORMULATIONS FOR OCULAR DELIVERY

1 . An aqueous formulation comprising

sodium citrate or sodium phosphate at a concentration of 8 to 12 mM;

sorbitol at 4% to 6% (w/v); and

poloxamer 188 at a concentration of 0.08% to 0.12% (w/v);

wherein the formulation has a pH of 5.5 to 7.5 and

wherein the formulation is effective for treating an ocular disorder.

2 . (canceled)

3 . The formulation of claim 1 , wherein the formulation is substantially free of a therapeutic protein.

4 . The formulation of claim 1 , wherein the formulation comprises

sodium citrate at a concentration of 9 to 11 mM;

sorbitol at 4.5 to 5.5% (w/v); and

poloxamer 188 at a concentration of 0.09 to 0.11%.

5 - 6 . (canceled)

7 . The formulation of claim 1 , further comprising sodium carboxymethyl cellulose at a concentration of 0.1-1%.

8 . The aqueous formulation of claim 1 , comprising

sodium citrate at a concentration of 9-11 mM;

sorbitol at 4.5-5.5% (w/v); and

poloxamer 188 at a concentration of 0.09-0.11%,

wherein the formulation has a pH of 5.7 to 6.3,

wherein the formulation is substantially free of therapeutic protein, and

wherein the formulation is effective for treating an ocular disorder.

9 . The formulation of claim 8 , wherein the ocular disorder is dry eye disease.

10 - 11 . (canceled)

12 . An aqueous formulation comprising

1-50 mg/ml of an IL-1β/IL-1Ra chimeric cytokine protein selected from P01, P02, P03, P04, P05, P06, or P07;

a buffering agent selected from sodium citrate and sodium phosphate;

sorbitol, e.g., at a concentration of 3.5-6.5% (w/v); and

poloxamer 188, e.g., at a concentration of 0.07-0.13% (w/v);

wherein the formulation has a pH of 5.5 to 7.5.

13 . The formulation of claim 12 , wherein the chimeric cytokine protein is P05.

14 - 33 . (canceled)

34 . The formulation of claim 1 , wherein the formulation does not comprise a viscosity agent.

35 . The formulation of claim 12 , wherein the formulation further comprises an amino acid.

36 . The formulation of claim 35 , wherein the formulation comprises one or more of arginine, glutamic acid, histidine, and methionine.

37 . The formulation of claim 36 , wherein methionine is present in the formulation at a concentration of 1 to 20 mM.

38 . The formulation of claim 37 , wherein the formulation has reduced oxidation, compared to a corresponding formulation that does not comprise methionine, when the formulation is subjected to storage for at least 4 weeks at 25° C.

39 . The formulation of claim 38 , wherein the formulation has reduced oxidation, compared to a corresponding formulation that does not comprise methionine, when the formulation is subjected to storage in a multidose container.

40 - 59 . (canceled)

60 . The formulation of claim 12 , wherein the formulation is packaged in a blow fill seal container.

61 - 63 . (canceled)

64 . A method of treating an ocular disorder, the method comprising administering to a subject having the ocular disorder an aqueous formulation comprising

sodium citrate or sodium phosphate at a concentration of 8 mM to 12 mM;

sorbitol at 4% to 6% (w/v); and

poloxamer 188 at a concentration of 0.08% to 0.12% (w/v);

wherein the formulation has a pH of 5.5 to 7.5 and is substantially free of therapeutic protein,

thereby treating the ocular disorder.

65 - 76 . (canceled)

77 . A container or device comprising the formulation of claim 1 .

78 . The container or device of claim 77 , wherein the container or device has been stored at 25° C. for at least two weeks and the formulation is substantially free of particulates.

79 - 87 . (canceled)

88 . The formulation of claim 8 , further comprising carboxymethyl cellulose.

89 . The formulation of claim 12 , further comprising carboxymethyl cellulose.

90 . The formulation of claim 12 , wherein the formulation does not comprise a viscosity agent.

91 . A method of treating an ocular disorder, the method comprising administering to a subject having the ocular disorder the formulation of claim 12 , thereby treating the ocular disorder.

92 . The container or device of claim 77 , wherein the container or device comprises a multidose container.

93 . The container or device of claim 77 , wherein the container or device comprises a blow fill seal container.

94 . A container or device comprising the formulation of claim 12 .