Back to results
US 12,005,097 B2Granted
Aflibercept formulations and uses thereof
AssigneeJust-Evotec Biologics, Inc.
InventorsBruce A. Kerwin, Julee A. Floyd, Alison J. Gillespie, Christine C Siska
Life of this patent
Estimating the term…
Abstract
Ophthalmic formulations comprising aflibercept are disclosed that are suitable for a method of treatment of an eye disorder or disease by intravitreal or topical administration.
Claims18
An ophthalmic formulation, comprising:
- (a) aflibercept in a concentration of 5-100 mg/mL;
- (b) a histidine buffer, wherein the histidine buffer concentration is 5-50 mM;
- (c) a non-ionic surfactant selected from the group consisting of a polysorbate, a polyethylene glycol dodecyl ether, a poloxamer, 4-(1,1,3,3-Tetramethylbutyl)phenyl-polyethylene glycol, an alkylsaccharide and an alkylglycoside, at a concentration of 0.001% (w/v) to 5% (w/v);
- (d) a tonicifying agent comprising a polyol or an amino acid selected from proline, arginine, aspartate, glutamate, glycine, histidine, isoleucine, and lysine, at a concentration of 2-4% (w/v), wherein the formulation has a final osmolality of 300±50 mOsm/kg;
- (e) an additional amino acid stabilizing agent selected from the group consisting of proline, arginine, methionine, lysine and mixtures thereof;
- and
- wherein the pH of the formulation is about pH 5.0 to about pH 6.5.
4 more elements
Dependencies are inferred from the claim text.