METHODS FOR THE TREATMENT OF PRESBYOPIA
The present invention is directed to treating presbyopia, irregular astigmatism, and/or refractive error, comprising administering a composition comprising from about 0.1% to about 3.5% w/v of aceclidine to a subject in need thereof, wherein administration occurs 2 or more times within 24 hours of initial administration.
1 . A method of treating presbyopia, irregular astigmatism, and/or refractive error, comprising administering a composition comprising from about 0.1% to about 3.5% w/v of aceclidine to a subject in need thereof, wherein administration occurs 2 or more times within 24 hours of initial administration and wherein w/v denotes weight by total volume of the composition.
2 . The method of claim 1 , wherein administration occurs 2 or more times within 1 hour of initial administration.
3 . The method of claim 1 , wherein administration occurs 2 or more times within 5 minutes of initial administration.
4 . The method of claim 1 , wherein the composition further comprises brimonidine at a concentration from about 0.001% to about 0.1% w/v.
5 . The method of claim 1 , wherein the composition further comprises brimonidine at a concentration from about 0.007% to about 0.009% w/v.
6 . 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, one or more viscosity agents and a polyol.
7 . The method of claim 6 , wherein the one or more nonionic surfactants are selected from the group consisting of a polysorbate, tyloxapol, a poloxamer, a cyclodextrin, vitamin E TPGS, a polyoxyl castor oil, a polyoxyl stearate, polyethylene glycol, a polyoxyethylene glycol alkyl ether, 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 a sorbitan, an octyl phenol ethoxylate, a nonoxynol, lauryl glucoside, cocamide, cetyl alcohol, glycerol monostearate, an alkyl polyglycoside, and an octoxynol.
8 . The method of claim 7 , wherein the one or more nonionic surfactants is a polysorbate.
9 . The method of claim 8 , wherein the one or more nonionic surfactants is polysorbate 80.
10 . The method of claim 6 , wherein the one or more viscosity agents are selected from the group consisting of cellulose, a cellulose derivative, glycerol, a dextran, gelatin, polyethylene glycol, hyaluronate, a carbomer, polyvinyl alcohol, 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 . The method of claim 6 , wherein the polyol is selected from the group consisting of mannitol, glycerol, erythritol, lactitol, xylitol, sorbitol, isosorbide, ethylene glycol, propylene glycol, maltitol, threitol, arabitol and ribitol.
14 . The method of claim 13 , wherein the polyol is mannitol.
15 . The method of claim 1 , wherein the administration to the subject in need thereof further improves night vision of the subject.
16 . The method of claim 1 , wherein the administration to the subject in need thereof does not result in loss of distance vision acuity in the subject.
17 . The method of claim 3 , wherein the administration to the subject in need thereof treats presbyopia and wherein the duration of treatment of presbyopia is extended from about 15% to about 30% as compared to a subject receiving a single administration of an identical composition.
18 . The method of claim 3 , wherein the administration to the subject in need thereof induces pupil constriction in an eye of the subject of about 2 millimeters or less for a duration of from about 8 to about 15 hours.
19 . A method of treating presbyopia, irregular astigmatism, and/or refractive error, comprising administering a composition comprising from about 0.1% to about 3.5% w/v of aceclidine to a subject in need thereof, wherein from about 0.0875 milligrams to about 0.35 milligrams of aceclidine are administered to the subject in need thereof within 8 hours.