Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dextenza Insert · 1 trial · 1 indication
Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs)
Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).
IOP measured in units of mmHg.
| Arm | Type | Description |
|---|---|---|
| Dextenza | EXPERIMENTAL | 1 dosing group - 37 eyes treated with Dextenza |
| Prednisolone | ACTIVE_COMPARATOR | 1 dosing group - 32 eyes treated with Prednisolone |
| Name | Type | Description |
|---|---|---|
| Dextenza Ophthalmic Insert | DRUG | 0.4mg insert for intracanalicular use |
| Prednisolone acetate ophthalmic suspension USP 1% | DRUG | 1 drop at end of surgery, followed by: 1 drop 4 x QID for one week. 1 drop 3 x QID for one week. 1 drop BID for one week. 1 drop QD for one week |
Inclusion Criteria: * Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for particip...
Dextenza Insert is used for the treatment of ocular pain and inflammation following surgery for pediatric cataract. It is an intracanalicular insert being developed by Ocular Therapeutix, Inc. for use in ophthalmology. The drug is administered to manage post-surgical symptoms in pediatric patients undergoing cataract surgery.
Dextenza Insert is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OCUL. The company is focused on developing therapies for ophthalmic conditions, and Dextenza Insert is one of its investigational products for managing ocular pain and inflammation after cataract surgery.
Dextenza Insert is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial for Dextenza Insert has been completed, and the drug is being studied for its safety and efficacy in treating ocular pain and inflammation following pediatric cataract surgery.
Dextenza Insert has one completed Phase 3 clinical trial registered under NCT04539548. The study, titled "A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract," enrolled 65 participants in the United States. The trial was active-controlled and included pediatric patients from birth.
Dextenza Insert is not FDA approved. It is an investigational drug currently in clinical development. The Phase 3 trial for Dextenza Insert has been completed, but the drug has not received regulatory approval. Its safety and efficacy are still being evaluated for the treatment of ocular pain and inflammation following pediatric cataract surgery.