Ocular compositions and methods

An aqueous formulation comprising:

• (a) about 0.1 wt. % to about 3 wt. % fibroin-derived protein wherein the primary amino acid sequences of the fibroin-derived protein differ from native fibroin by at least 6% with respect to the absolute values of the combined differences in amino acid content of serine, glycine, and alanine;
• cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains of the fibroin-derived protein are reduced or eliminated;
• the fibroin-derived protein comprises greater than 46% glycine amino acids and greater than 30% alanine amino acids;
• the fibroin-derived protein has a serine content that is reduced by greater than 40% compared to native fibroin protein such that the fibroin-derived protein comprises less than 8% serine amino acids;
• and the average molecular weight of fibroin-derived protein is about 15 kDa to about 35 kDa;
• (b) polysorbate-80;
• (c) about 10 millimolar to about 50 millimolar acetate buffer;
• and
• (d) one or more osmotic agents;
• wherein the formulation has a pH of 5.2 to 5.8;
• an osmolality of 175 mOsm/kg to 185 mOsm/kg;
• and a particulate count of 50/mL or less after a storage period of greater than 12 weeks at 4° C. to 40° C., with respect to particulates having a diameter of 10 micrometers or more.

An aqueous formulation comprising:

• (a) water;
• (b) polysorbate 80;
• (c) a buffering system comprising acetic acid and sodium acetate;
• and
• (d) magnesium chloride and dextrose as osmotic agents;
• wherein the formulation has a pH of 5.4 to 5.6 and an osmolality of 175 mOsm/kg to 185 mOsm/kg.