COMPOSITIONS AND METHODS FOR THE TREATMENT OF PRESBYOPIA
The present invention is directed to compositions for and methods for the treatment of presbyopia comprising from about 0.3% to about 2.0% w/v aceclidine and from about 0.07% to about 0.15% w/v brimonidine.
1 . A method of treating presbyopia comprising administering a composition comprising from about 0.3% to about 2% w/v aceclidine 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 aceclidine is at a concentration from about 1% to bout 2% w/v.
3 . The method of claim 1 , wherein brimonidine is at a concentration from about 0.07% to about 0.09% w/v.
4 . The method of claim 1 , wherein the pH is about 6.0 or less.
5 . 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.
6 . The method of claim 5 , 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.
7 . The method of claim 5 , 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-dodecahy dro-1H-cyclopenta[a] phenanthren-3-yl]oxy] ethanol .
8 . The method of claim 7 , wherein the one or more nonionic surfactants is a polysorbate.
9 . The method of claim 7 , wherein the one or more nonionic surfactants is polysorbate 80.
10 . The method of claim 5 , 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.
11 . The method of claim 10 , wherein the one or more viscosity agents are cellulose derivatives.
12 . The method of claim 11 , wherein the one or more viscosity agents is carboxymethyl cellulose or hydroxypropylmethyl cellulose.
13 . A method of treating presbyopia comprising administering a composition comprising from about 1% to about 2% w/v aceclidine and from about 0.07% to about 0.09% w/v brimonidine to a subject in need thereof, wherein w/v denotes weight by total volume of the composition.
14 . The method of claim 13 , wherein brimonidine is at a concentration of about 0.08% w/v.
15 . The method of claim 13 , wherein the composition further comprises from about 2% to about 5% w/v polysorbate 80 and from about 1.25% to about 1.40% w/v carboxymethyl cellulose or hydroxypropylmethyl cellulose.
16 . The method of claim 13 , wherein the pH is from about 4.5 to about 6.5.