Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis. ( 1 ) FDA label
Also known as TP-03
Xdemvy · 3 trials · 3 indications
The proportion of subjects cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values
The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days |
| Control | PLACEBO_COMPARATOR | Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days |
| BID Dosing | EXPERIMENTAL | TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day to maintain masking for approximately 85 days |
| TID Dosing | EXPERIMENTAL | TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days |
| Name | Type | Description |
|---|---|---|
| TP-03 | DRUG | TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day |
| TP-03 Vehicle | DRUG | Vehicle of TP-03 ophthalmic solution, administered twice a day |
| TP-03, 0.25% | DRUG | TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day |
Inclusion Criteria: * Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol * Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the ...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 1 | PHASE4 | GLK-321 |
Xdemvy is used to treat blepharitis and Meibomian Gland Dysfunction, eye conditions linked to Demodex infestation. It is a small molecule developed by Tarsus Pharmaceuticals, Inc. (ticker TARS) and studied in adults 18 years and older in placebo-controlled trials conducted in the United States.
Xdemvy targets Demodex, the microscopic mites associated with blepharitis and Meibomian Gland Dysfunction. By acting on Demodex, the drug addresses the underlying infestation tied to these eyelid conditions. Xdemvy is a small molecule and is also known as TP-03 (Lotilaner Ophthalmic Solution), 0.25%.
Xdemvy is developed by Tarsus Pharmaceuticals, Inc., which trades under the ticker TARS. The company is the sponsor behind the clinical program for TP-03, also called Xdemvy, in ophthalmology. Its studies have focused on blepharitis and Meibomian Gland Dysfunction in adult patients.
Xdemvy has been studied in Phase 3 clinical development. It is an investigational small molecule for blepharitis and Meibomian Gland Dysfunction, and the program includes completed Phase 2 and Phase 3 trials. The Phase 3 study NCT04784091 evaluated TP-03 for Demodex blepharitis in 412 participants.
Xdemvy has been evaluated in completed trials including NCT04784091, a Phase 3 study of TP-03 for Demodex blepharitis with 412 participants, and NCT04475432, a Phase 2 study in Demodex blepharitis with 421 participants. A Phase 2 pilot study, NCT05454956, compared two dosing regimens of TP-03 for Meibomian Gland Dysfunction in 39 participants.
Yes, Xdemvy is also known as TP-03 (Lotilaner Ophthalmic Solution), 0.25%, and simply TP-03. These names refer to the same Tarsus Pharmaceuticals small molecule studied for blepharitis and Meibomian Gland Dysfunction. Searches for TP-03 and Xdemvy point to the same investigational ophthalmology asset.