Isoxazoline parasiticide formulations and methods for treating blepharitis

Inventors

Azamian, Bobak RobertAckermann, Douglas MichaelHickok, Shawn D.Vehige, Joseph G.

Assignees

Tarsus Pharmaceuticals Inc

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-12171750-B2

Patent

Publication Date

2024-12-24

Expiration Date


Abstract

Disclosed herein are methods for treating or preventing ophthalmic and dermatologic conditions in a patient, including ocular surface conditions such as blepharitis. The methods can include topically administering directly to an ocular surface of one or more eyes of a patient in need of treatment thereof an effective amount of an isoxazoline parasiticide, formamidine parasiticide, or other active ingredient, formulated into an ophthalmic composition, the ophthalmic composition further comprising a pharmaceutically acceptable vehicle. Compositions are also disclosed.

Core Innovation

The invention relates to methods for treating an ocular Demodex infestation in a human patient and for reducing cylindrical eyelash dandruff by topically administering, directly to an ocular surface of one or more eyes, an ophthalmic composition comprising lotilaner. The ophthalmic composition is therapeutically effective only locally and is provided in direct ocular surface administration.

In the disclosed ocular infestation treatment, the ophthalmic composition comprises an effective amount of lotilaner present between about 0.10% and about 0.50% by weight with respect to the total weight of the composition. The composition further comprises hydrogenated castor oil and a polysaccharide thickener.

The disclosed embodiments emphasize formulation characteristics that support ocular surface retention and spreading, including viscosity that spreads over meibomian gland orifices upon blinking or closing of the eye and slows evacuation through the eye puncta for at least 20 seconds. Example formulation limitations described include selectable preservative agents and exclusion of tea tree oil in certain embodiments, supporting a sterile, non-irritating ophthalmic composition.

For reducing cylindrical eyelash dandruff, the invention further provides locally therapeutically effective methods using an ophthalmic composition comprising lotilaner. The ophthalmic composition is described in eye drop form for one embodiment and in a gel, ointment, or cream form for another embodiment, each for only local therapeutic effectiveness.

Claims Coverage

The provided content contains three independent claims. Across these claims, the inventive subject matter centers on direct topical ocular surface administration of a locally effective ophthalmic composition containing lotilaner, with specified formulation components and dosage forms.

Direct topical ocular surface administration with lotilaner composition

A method for treating an ocular Demodex infestation in a human patient comprising topically administering directly to an ocular surface of one or more eyes an ophthalmic composition comprising an effective amount of lotilaner, wherein the lotilaner is present between about 0.10% and about 0.50% by weight, and wherein the ophthalmic composition further comprises hydrogenated castor oil and a polysaccharide thickener.

Eye drop for local reduction of cylindrical eyelash dandruff

A method for reducing cylindrical eyelash dandruff in a human patient comprising topically administering directly to an ocular surface of one or more eyes an ophthalmic composition comprising lotilaner, wherein the ophthalmic composition is in eye drop form, and wherein the ophthalmic composition is only locally therapeutically effective.

Gel, ointment, or cream for local reduction of cylindrical eyelash dandruff

A method for reducing cylindrical eyelash dandruff in a human patient comprising topically administering directly to an ocular surface of one or more eyes an ophthalmic composition comprising lotilaner, wherein the ophthalmic composition is formulated as a gel, an ointment, or a cream, and wherein the ophthalmic composition is only locally therapeutically effective.

Overall claim coverage is anchored by direct topical ocular surface administration of a lotilaner-containing ophthalmic composition for treating ocular Demodex infestation and reducing cylindrical eyelash dandruff.

Stated Advantages

Provides a locally therapeutically effective ophthalmic approach by topically administering directly to the ocular surface.

Supports ocular surface retention and spreading, including spreading over meibomian gland orifices and slowing evacuation through the eye puncta for at least 20 seconds.

Documented Applications

Treating an ocular Demodex infestation in a human patient.

Reducing cylindrical eyelash dandruff in a human patient.

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.