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IRX-101 · 2 trials · 1 indication
Demonstrate the superiority of IRX-101 compared to PI in terms of reducing patient-reported post-intravitreal injection eye pain; pain will be assessed using the visual analog pain scale, a validated patient-reported outcome measure (questionnaire) for assessing patient's subjective pain and discomfort
Safety will be measured via slit lamp and fundoscopic examinations
| Arm | Type | Description |
|---|---|---|
| IRX-101 | EXPERIMENTAL | Subjects randomized to IRX-101 will receive the investigational product, IRX-101. |
| 5% Povidone-iodine | ACTIVE_COMPARATOR | Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%. |
| Name | Type | Description |
|---|---|---|
| IRX-101 | DRUG | IRX-101 is a novel ocular anti-septic |
| Providone-Iodine | DRUG | 5% Providone-Iodine |
Inclusion Criteria: 1. Capable of giving informed consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes Exclusion Criteria: 1. Curren...
IRX-101 is an investigational small molecule being developed by Tarsus Pharmaceuticals for use in retinal disease. It is designed to improve patient comfort and safety during intravitreal injections, which are common treatments for retinal conditions. The drug is currently in Phase 3 clinical development and has not yet been approved by the FDA.
IRX-101 is being developed by Tarsus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker TARS. The company is conducting clinical trials to evaluate the safety and tolerability of IRX-101 in patients receiving intravitreal injections for retinal disease.
IRX-101 is currently in Phase 3 clinical development. The Phase 3 trial, NCT05750589, is a randomized, double-blind, active-controlled study designed to evaluate the safety and tolerability of IRX-101 in patients receiving intravitreal injections. The trial is not yet recruiting and has an estimated enrollment of 240 participants.
IRX-101 has been studied in two clinical trials. The completed Phase 2 trial, NCT05747430, enrolled 155 participants and was titled 'SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)'. The ongoing Phase 3 trial, NCT05750589, is titled 'Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections' and is not yet recruiting.
IRX-101 is a small molecule designed to improve patient comfort during intravitreal injections for retinal disease. Its mechanism of action is not publicly detailed in the available information, but it is being evaluated for its safety and tolerability in clinical trials.