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 (Lotilaner Ophthalmic Solution), 0.25%, TP-03, 0.25%, TP-03
Xdemvy · 4 trials · 4 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
Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
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.
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Cmax at various times
Safety will be evaluated through the incidence rate of TEAEs
Evaluate the safety of TP-03 through clinically significant changes from Baseline chemistry laboratory tests
Evaluate the safety of TP-03 through clinically significant changes from Baseline hematology laboratory tests
Safety will be evaluated through review of clinically significant changes in physical examinations from Baseline
Safety will be evaluated through review of clinically significant changes in electrocardiograms from Baseline
Safety will be evaluated through review of clinically significant changes from Baseline vital signs (including temperature \[degrees Celsius\], pulse rate \[beats per minute\], respiration rate \[breaths per minute\], and changes in systolic and diastolic blood pressure \[mmHg\]) from Baseline
Safety will be evaluated through review of clinically significant changes in corrected distance visual acuity from Baseline
Safety will be evaluated through review of clinically significant changes in non-mydriatic fundus photographs from Baseline
Safety will be evaluated through review of clinically significant changes in IOP from Baseline
| 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 |
| TP-03 (Lotilaner Ophthalmic Solution), 0.25% | EXPERIMENTAL | TP-03, topical ocular administration in healthy adults. Single and multiple doses for 42 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 |
| TP-03 (Lotilaner Ophthalmic Solution), 0.25% | DRUG | A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye. |
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 being developed for blepharitis, including Demodex blepharitis, and for meibomian gland dysfunction. It is an ophthalmic small molecule therapy studied in adult patients. Development has focused on inflammatory eyelid conditions associated with Demodex infestation.
Xdemvy is developed by Tarsus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker TARS. The company sponsors the clinical program for the drug, including the Phase 3 and Phase 2 trials conducted in the United States.
Xdemvy has completed Phase 3 clinical development. A Phase 3 trial in Demodex blepharitis and a Phase 2 trial in meibomian gland dysfunction and blepharitis have both been completed, along with earlier Phase 1 and Phase 2 studies.
Xdemvy has been studied in completed trials including NCT04784091, a Phase 3 trial in Demodex blepharitis with 412 participants, and NCT04475432, a Phase 2 trial in Demodex blepharitis with 421 participants. Additional completed studies include NCT05454956 in meibomian gland dysfunction and NCT05138861 in healthy subjects.
Yes, Xdemvy is also known as TP-03, or lotilaner ophthalmic solution, 0.25%. TP-03 is the development code used in the clinical trial listings, while Xdemvy is the drug's name. Both refer to the same ophthalmic small molecule therapy from Tarsus Pharmaceuticals.
Across the reported Xdemvy studies, total enrollment was 833 participants. The largest trials were the Phase 3 study NCT04784091 with 412 participants and the Phase 2 study NCT04475432 with 421 participants, both in Demodex blepharitis and both randomized, double-blind, and placebo-controlled.