Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bromfenac · 8 trials · 6 indications
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)
Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)
Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none
| Arm | Type | Description |
|---|---|---|
| Bromfenac Ophthalmic Solution | EXPERIMENTAL | Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. |
| Placebo | PLACEBO_COMPARATOR | One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. |
| Bromfenac ophthalmic solution 0.09% | EXPERIMENTAL | dosed 1 drop daily in study eye for 2 weeks |
| Bromfenac | EXPERIMENTAL | Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily |
| 1-bromfenac ophthalmic solution | EXPERIMENTAL | sterile ophthalmic solution |
| 2-placebo comparator | PLACEBO_COMPARATOR | sterile ophthalmic solution |
| Bromfenac Ophthalmic Solution 0.18% | EXPERIMENTAL | - |
| Xibrom 0.09% | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bromfenac Ophthalmic Solution | DRUG | Sterile ophthalmic solution |
| Placebo | DRUG | Sterile ophthalmic solution |
| Placebo Comparator | DRUG | sterile ophthalmic solution |
| Bromfenac | DRUG | sterile ophthalmic solution |
Inclusion Criteria: * Male or female at least 18 years of age who are scheduled for unilateral cataract surgery Exclusion Criteria: * Have known hypersensitivity to bromfenac or to any component of the investigational product
Bromfenac is an ophthalmic solution used to treat pain and inflammation associated with cataract surgery. It is also indicated for conditions such as cataract, allergic conjunctivitis, and postoperative complications. The drug is administered as eye drops and is currently in Phase 3 clinical development.
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting the cyclooxygenase enzymes, thereby reducing prostaglandin synthesis. This action helps decrease inflammation and pain in the eye following cataract surgery. The drug is applied topically to the eye.
Bromfenac is developed by Bausch + Lomb Corporation, a company publicly traded under the ticker symbol BLCO. Bausch + Lomb is a global eye health company that focuses on pharmaceuticals, contact lenses, and surgical products.
Bromfenac is in Phase 3 clinical development. It has completed three Phase 3 trials, with a total enrollment of 1,261 participants. These trials were randomized, double-blind, and placebo-controlled, evaluating the safety and efficacy of the drug for ocular inflammation and pain.
Bromfenac has completed three Phase 3 trials. NCT00333918 enrolled 522 patients for ocular inflammation and pain after cataract surgery. NCT00703781 enrolled 126 patients for cataract. NCT00853970 enrolled 299 patients for pain and inflammation. NCT01367249 enrolled 440 patients for pain, inflammation, and cataract.
Bromfenac is a specific NSAID eye drop, distinct from other agents like ketorolac or nepafenac. It is formulated as a 0.09% solution and is applied twice daily. Its efficacy in reducing postoperative inflammation and pain has been established in clinical trials, though it is not yet approved.