COMPOSITIONS AND METHODS FOR THE TREATMENT OF EYE CONDITIONS
The present invention is directed to compositions for and methods for the treatment of presbyopia, irregular astigmatism, and/or refractive error comprising from about 0.1% to about 4.0% w/v of a muscarinic agonist and from about 0.07% to about 0.15% w/v brimonidine.
1 . A method of treating an eye condition selected from the group consisting of presbyopia, irregular astigmatism, and refractive error, comprising administering a composition comprising from about 0.1% to about 4.0% w/v of a muscarinic agonist and from about 0.07% to about 0.15% w/v brimonidine to a subject in need thereof, wherein w/v denotes weight by total volume of the composition.
2 . The method of claim 1 , wherein the muscarinic agonist is selected from the group consisting of aceclidine, pilocarpine, carbachol and a combination thereof.
3 . The method of claim 1 , wherein the muscarinic agonist is aceclidine at a concentration from about 0.3% to about 2% w/v.
4 . The method of claim 1 , wherein the muscarinic agonist is pilocarpine at a concentration from about 0.3% to about 2% w/v.
5 . The method of claim 1 , wherein the muscarinic agonist is carbachol at a concentration from about 1% to about 4% w/v.
6 . The method of claim 1 , wherein brimonidine is at a concentration from about 0.07% to about 0.09% w/v.
7 . The method of claim 1 , wherein the composition further comprises a cycloplegic agent.
8 . The method of claim 7 , wherein the cycloplegic agent is at a concentration from about 0.0001% to about 0.01% w/v.
9 . The method of claim 7 , wherein the cycloplegic agent is tropicamide.
10 . The method of claim 9 , wherein tropicamide is at a concentration from about 0.001% to about 0.075% w/v.
11 . The method of claim 10 , wherein tropicamide is at a concentration of about 0.0035% w/v.
12 . The method of claim 1 , wherein the pH is about 6.5 or less.
13 . The method of claim 1 , wherein the composition further comprises one or more excipients selected from the group consisting of one or more nonionic surfactants and one or more viscosity agents.
14 . The method of claim 13 , wherein the one or more nonionic surfactants are at a concentration from about 1% to about 5% w/v and the one or more viscosity agents are at a concentration that provides from about 50 to about 5,000 centipoise at 25° C. and 0 shear.
15 . The method of claim 13 , wherein the one or more nonionic surfactants are selected from the group consisting of a polysorbate, tyloxapol, a poloxamer, a cyclodextrin, octoxynol 40, vitamin E TPGS, a polyoxyl castor oil, a polyoxyl stearate, polyethylene glycol, a polyoxyethylene glycol alkyl ether and 2-[[10,13-dimethyl-17-(6-methylheptan-2-yl)-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3 -yl]oxy]ethanol
16 . The method of claim 13 , wherein the one or more nonionic surfactants is a polysorbate.
17 . The method of claim 16 , wherein the one or more nonionic surfactants is polysorbate 80.
18 . The method of claim 13 , wherein the one or more viscosity agents are selected from the group consisting of a cellulose derivative, hyaluronate, a carbomer, polyvinyl chloride, polyvinyl pyrrolidone and a gum.
19 . The method of claim 18 , wherein the one or more viscosity agents are cellulose derivatives.
20 . The method of claim 19 , wherein the one or more viscosity agents is carboxymethyl cellulose or hydroxypropylmethyl cellulose.