OPHTHALMIC COMPOSITIONS FOR TREATING DRY EYE SYNDROME Russian patent published in 2024 - IPC A61K9/08 A61K38/13 A61K47/06 A61K47/10 A61P27/04 

Abstract RU 2828769 C2

FIELD: medicine.

SUBSTANCE: group of inventions relates to ophthalmology, namely to a method of improving visual function, a method of treating and/or normalizing dryness symptoms and a method of treating dry keratoconjunctivitis. Disclosed is a method for improving visual function in a patient suffering dry eye syndrome (dry keratoconjunctivitis), wherein the patient is characterized by that he has: total ocular surface disease index (OSDI) equal to or greater than 55; at least one eye with a fluorescein staining score of 3 (NEI scale); and at least one eye with a total fluorescein staining score of at least 11 (on the NEI scale) at the initial level, wherein the visual function is improved in the patient, and wherein the method involves a step of administering composition containing 0.1 wt./v.% of cyclosporine dissolved in 1-(perfluorobutyl)pentane, and up to 1.0 wt./wt.% of ethanol into the patient's eye, wherein said composition is introduced into the eye twice a day in a dose of one drop in a volume of approximately 8–12 mcl per eye. Method of treating and/or normalizing dryness symptoms associated with keratoconjunctivitis (dry eye syndrome) in a patient in need thereof, involving the local administration of an ophthalmic composition containing 0.1 wt./v.% of cyclosporine, dissolved in 1-(perfluorobutyl)pentane, and up to 1.0 wt./wt.% of ethanol, wherein said composition is administered into the eye twice a day in a dose of one drop of 8–10 mcl per eye, wherein the patient has said indicators; wherein the method is effective for reducing the total score of corneal staining with fluorescein in at least one eye by at least 3 points after 4 weeks of treatment. Method of treating dry keratoconjunctivitis (dry eye syndrome) involving a stage of local administration of an ophthalmic composition containing 0.1 wt./v.% of cyclosporine, dissolved in 1-(perfluorobutyl)pentane, and up to 1.0 wt./wt.% of ethanol; wherein said composition is administered into the eye twice a day in a dose of one drop in a volume of about 8–10 mcl per eye, wherein the patient has said values; wherein said methods are effective for reducing the total score of corneal staining with fluorescein in at least one eye by at least 3 points.

EFFECT: use of the group of inventions provides the treatment of dry eye syndrome, in which the following parameters are simultaneously observed in the patient: higher average change in total OSDI relative to baseline in patients with OSDI ≥ 55 compared to the general population of patients in the study, improved visual function in a patient is characterized by a decrease in the total score of corneal staining with fluorescein (according to the NEI scale) by 3 or more units, at least one eye with a fluorescein staining score of 3 (on the NEI scale), a total fluorescein staining score for at least one eye of at least 11 on the NEI scale at the initial level.

23 cl, 11 dwg, 1 ex

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RU 2 828 769 C2

Authors

Leo, Kiara Silvana

Kresser, Sonya

Shlyuter, Tomas

Majdes, Alisa

Dates

2024-10-17Published

2019-10-11Filed