Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TP-03 · 1 trial · 3 indications
Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
| Arm | Type | Description |
|---|---|---|
| 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 in participants in the BID dosing arm and three times a day in participants in the TID dosing arm |
| TP-03 Vehicle | DRUG | Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms |
Inclusion Criteria: * Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol * Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more m...
TP-03 is an investigational small molecule being developed by Tarsus Pharmaceuticals for the treatment of Demodex blepharitis, Meibomian Gland Dysfunction, and related eyelid conditions. It has been studied in clinical trials for blepharitis and Meibomian Gland Dysfunction, with trials also conducted in healthy subjects.
TP-03 is being studied for conditions associated with Demodex mite infestation, including Demodex blepharitis and Meibomian Gland Dysfunction. The clinical trials for TP-03 specifically evaluate its safety and efficacy in treating Demodex blepharitis, indicating its mechanism is directed at addressing Demodex-related eyelid disease.
TP-03 is being developed by Tarsus Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol TARS. Tarsus is conducting clinical trials to evaluate TP-03 for the treatment of Demodex blepharitis and Meibomian Gland Dysfunction.
TP-03 has completed Phase 1, Phase 2, and Phase 3 clinical trials. The completed trials include a Phase 3 study for Demodex blepharitis, Phase 2 studies for blepharitis and Meibomian Gland Dysfunction, and a Phase 1 pharmacokinetic study in healthy subjects. TP-03 remains an investigational drug and is not yet approved.
TP-03 has been evaluated in four completed clinical trials. These include NCT04475432 and NCT04784091, both studying TP-03 for Demodex blepharitis in the United States, NCT05138861, a pharmacokinetic study in healthy subjects in Canada, and NCT05454956, a pilot study for Meibomian Gland Dysfunction and blepharitis in the United States.
TP-03 is also known as XDEMVY, a brand name for lotilaner ophthalmic solution. XDEMVY is the commercial name under which TP-03 has been studied for the treatment of Demodex blepharitis. Both names refer to the same investigational drug developed by Tarsus Pharmaceuticals.