Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Dextenza Ophthalmic Insert
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 an ophthalmic small molecule developed by Ocular Therapeutix, Inc. (ticker OCUL) for use in cataract surgery. It is designed to treat ocular pain and inflammation following surgery, including surgery for pediatric cataract. It is currently in Phase 3 clinical development.
Dextenza Insert is being studied for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The Phase 3 program enrolled pediatric patients aged 0 years and older in the United States. It is an investigational therapy and has not been established as approved for this use.
Dextenza Insert is developed by Ocular Therapeutix, Inc., which trades under the ticker OCUL. The company is the sponsor of the clinical program evaluating the insert in cataract surgery.
Dextenza Insert is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The program is investigational, and the available information does not indicate FDA approval.
Dextenza Insert has been evaluated in one completed Phase 3 trial, NCT04539548, titled a study assessing the safety and efficacy of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The trial enrolled 65 participants in the United States and used an active-controlled, randomized design.
Yes, Dextenza Insert and Dextenza Ophthalmic Insert refer to the same product. Dextenza Ophthalmic Insert is an alternative name for the ophthalmic insert developed by Ocular Therapeutix, Inc. (OCUL) for ocular pain and inflammation following pediatric cataract surgery.