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Last Updated: December 15, 2025

Claims for Patent: 12,059,449

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Summary for Patent: 12,059,449

Title:	Ophthalmic composition for treatment of dry eye disease
Abstract:	The invention provides ophthalmic compositions comprising about 0.1% (w/v) cyclosporine dissolved in 1-(perfluorobutyl)pentane for use in the topical treatment of dry eye disease and provides for treatment methods thereof. The invention further provides kits comprising such compositions.
Inventor(s):	Chiara Silvana Leo, Sonja KRÖSSER, Thomas Schlüter, Alice MEIDES
Assignee:	Novaliq GmbH
Application Number:	US17/711,932
Patent Claims:	1. A method for increasing tear production volume in a patient in need thereof, wherein the patient suffers from keratoconjunctivitis sicca, comprising topically administering to the eye of the patient a daily dosage of 20 μg of cyclosporine, wherein the cyclosporine is administered as an ophthalmic composition comprising 0.1% (w/v) cyclosporine dissolved in 1-(perfluorobutyl)pentane, and optionally up to 1.0% (w/w) ethanol, wherein the composition is topically administered twice per day as a single drop per dose per eye, wherein the drop has a volume of about 8 to 10 μl; and wherein the patient in at least one eye, or alternatively both eyes, is characterized by a Schirmer's Test 1 score of between 3 mm and 7 mm. 2. The method according to claim 1, wherein the composition consists of 0.1% (w/v) cyclosporine dissolved in 1-(perfluorobutyl)pentane and 1.0% (w/w) ethanol. 3. The method according to claim 1, wherein the composition consists of 0.1% (w/v) cyclosporine dissolved in 1-(perfluorobutyl)pentane. 4. The method according to claim 1, wherein the patient's tear production is suppressed or is presumed to be suppressed because of ocular inflammation associated with keratoconjunctivitis sicca. 5. The method according to claim 4, wherein the patient having keratoconjunctivitis sicca experiences any one of, or a combination of tear hyperosmolarity, tear film instability or abnormalities in the lipid layer composition of the tear film. 6. The method according to claim 4, wherein the keratoconjunctivitis sicca is caused by ocular surgical intervention. 7. The method according to claim 4, wherein the patient is unresponsive to prior treatment of keratoconjunctivitis sicca. 8. The method according to claim 4, wherein the composition is effective in reducing one or more signs and/or symptoms of keratoconjunctivitis sicca. 9. The method according to claim 1, wherein the patient has a total ocular surface disease index (OSDI) score of equal or greater than 45. 10. The method according to claim 1, wherein the patient in at least one eye, or alternatively both eyes, is further characterized by: (a) a total corneal fluorescein staining score of ≥10 according to NEI grading; and/or (b) a total lissamine green conjunctival score (sum of temporal and nasal regions) of ≥2 according to the Oxford scale. 11. The method according to claim 1, wherein the Schirmer's test is performed without anesthesia. 12. The method according to claim 1, wherein the composition is substantially free of a preservative. 13. The method according to claim 12, wherein the composition is effective in inhibiting microbial growth. 14. The method according to claim 13, wherein the composition is provided in a container for holding multiple (a plurality) of doses of the composition. 15. The method according to claim 1, wherein the composition is in the form of a clear solution. 16. The method according to claim 1, wherein the patient has a total ocular surface disease index (OSDI) score of equal or greater than 55. 17. The method according to claim 1, wherein the onset of effect is within 2 weeks.

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