Methods for treating demodex blepharitis using lotilaner formulations

Inventors

Azamian, Bobak Robert • Ackermann, Douglas Michael • Hickok, Shawn D. • Vehige, Joseph G.

Assignees

Tarsus Pharmaceuticals Inc

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 disclosure relates to treating Demodex blepharitis and Demodex infestation affecting ocular structures by topically administering an ophthalmic composition. The composition uses lotilaner as an active ingredient together with a pharmaceutically acceptable vehicle, with lotilaner present at about 0.25% by weight with respect to the total weight of the composition administered.

The described treatment is directed to topical ocular surface sites, including the eye and an ocular surface of one or more eyes of a human patient. For Demodex blepharitis, the method includes direct topical administration to the ocular surface. For Demodex infestation linked dysfunction, the treatment is administered directly to one or more of the eye, eyelids, or eyelashes.

The disclosure further characterizes dosing as topical administration of an ophthalmic composition formulated in a vehicle, with example dosage form refinement including an eye drop. Quantitative regimen constraints include administration frequency and minimum treatment duration thresholds, and further constrain a per-administration amount to a defined microliter range in certain dependent formulations.

Claims Coverage

Two independent claims are present, both centered on topical ophthalmic treatment using lotilaner at about 0.25% by weight in a pharmaceutically acceptable vehicle. The claim set covers treatment of Demodex blepharitis and treatment of Meibomian gland dysfunction caused by Demodex infestation, with further claim coverage refining ocular site targeting, dosage form, dosing frequency, minimum duration, and per-administration volume.

Across the two independent claims, the inventive coverage is the direct topical administration of an effective ophthalmic composition containing lotilaner at about 0.25% by weight in a pharmaceutically acceptable vehicle, directed either to the ocular surface for Demodex blepharitis or to the eye, eyelids, or eyelashes for Meibomian gland dysfunction caused by Demodex infestation.

Stated Advantages

Documented Applications

No documented applications found