US2022409603A1PendingUtilityA1

Ophthalmic composition

Assignee: SYDNEXIS INCPriority: Apr 23, 2015Filed: Aug 24, 2022Published: Dec 29, 2022
Est. expiryApr 23, 2035(~8.8 yrs left)· nominal 20-yr term from priority
A61K 47/186A61K 9/0048A61K 9/08A61K 47/183A61K 9/06A61K 31/46A61K 47/02A61P 27/02A61K 47/40
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Claims

Abstract

Provided herein is an ophthalmic composition. In some embodiments, the ophthalmic composition includes a low concentration of an ophthalmic agent for treatment of an ophthalmic disorder or condition; and an ophthalmically acceptable carrier, wherein the ophthalmic agent is distributed with substantial uniformity throughout the ophthalmically acceptable carrier. Further disclosed herein include an ophthalmic composition including a low concentration of an ophthalmic agent and deuterated water. Also disclosed herein are methods of arresting or preventing myopia development by administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition as described herein.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A stabilized ophthalmic composition for treating pre-myopia, myopia, or progression of myopia, comprising from about 0.001 wt % to about 0.05 wt % of atropine or atropine sulfate and water, wherein the stabilized ophthalmic composition further comprises a buffering agent at a pH from about 4.4 to about 6.4, wherein the stabilized ophthalmic composition is a liquid, wherein the buffer agent has a buffer capacity sufficient to maintain the pH of the solution between about 4.4 to about 6.4 for an extended period of time of at least 1 month. 
     
     
         2 . The stabilized ophthalmic composition of  claim 1 , further comprising noratropine, atropine-N-oxide, tropine, tropic acid, hyoscine, scopolamine, tropicamide, cyclopentolate, pirenzepine, homatropine, or a combination thereof. 
     
     
         3 . The stabilized ophthalmic composition of  claim 1 , wherein the atropine or atropine sulfate is present in the composition at a concentration of from about 0.001 wt % to about 0.03 wt %. 
     
     
         4 . The stabilized ophthalmic composition of  claim 1 , wherein the atropine or atropine sulfate is present in the composition at a concentration of from about 0.001 wt % to about 0.02 wt %. 
     
     
         5 . The stabilized ophthalmic composition of  claim 1 , wherein the atropine or atropine sulfate is present in the composition at a concentration of from about 0.001 wt % to about 0.01 wt %. 
     
     
         6 . The stabilized ophthalmic composition of  claim 1 , wherein the buffering agent comprises an acetate buffering agent, a citrate buffering agent, a carbonate buffering agent, an organic buffering agent, and amino acid buffering agent, or a combination thereof. 
     
     
         7 . The stabilized ophthalmic composition of  claim 1 , wherein the buffering agent comprises an acetate buffering agent or a citrate buffering agent, or a combination thereof. 
     
     
         8 . The stabilized ophthalmic composition of  claim 1 , wherein the stabilized ophthalmic composition further comprises a tonicity adjusting agent. 
     
     
         9 . The stabilized ophthalmic composition of  claim 8 , wherein the tonicity adjusting agent comprises a halide salt of a monovalent cation. 
     
     
         10 . The stabilized ophthalmic composition of  claim 1 , further comprising an ophthalmically acceptable viscosity agent. 
     
     
         11 . The stabilized ophthalmic composition of  claim 10 , wherein the ophthalmically acceptable viscosity agent comprises hydroxyethyl cellulose, hydroxypropyl cellulose, or hydroxypropylmethyl-cellulose (HPMC). 
     
     
         12 . The stabilized ophthalmic composition of  claim 1 , further comprising a preservative. 
     
     
         13 . The stabilized ophthalmic composition of  claim 12 , wherein a concentration of the preservative is from about 0.0001% to about 1%. 
     
     
         14 . The stabilized ophthalmic composition of  claim 12 , wherein the preservative is selected from benzalkonium chloride, cetrimonium, sodium perborate, stabilized oxychloro complex, polyquaternium-1, chlorobutanol, edetate disodium, polydexamethylene biguanide, or combinations thereof. 
     
     
         15 . The stabilized ophthalmic composition of  claim 1 , wherein the stabilized ophthalmic composition is essentially free of procaine and benactyzine, or pharmaceutically acceptable salts thereof. 
     
     
         16 . A method of treating the pre-myopia, myopia or progression of myopia in an individual in need thereof, comprising administering to an eye of the individual an effective amount of the stabilized ophthalmic composition of  claim 1 . 
     
     
         17 . The method of  claim 16 , wherein the stabilized ophthalmic composition is administered topically. 
     
     
         18 . The method of  claim 16 , wherein the stabilized ophthalmic composition is administered by instillation. 
     
     
         19 . The method of  claim 16 , wherein the stabilized ophthalmic composition is administered through an eye drop bottle containing the stabilized ophthalmic composition.

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