Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mapracorat · 5 trials · 5 indications
Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, where higher scores indicated worse pain.
Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.
The mean endothelial cell density (cells/mm2)(ECD)
| Arm | Type | Description |
|---|---|---|
| Mapracorat | EXPERIMENTAL | Mapracorat ophthalmic suspension, 3%, |
| Vehicle | PLACEBO_COMPARATOR | The vehicle of the mapracorat ophthalmic suspension |
| Mapracorat Vehicle | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Mapracorat | DRUG | 1 drop of study medication into the study eye QID for 14 days |
| Placebo | DRUG | 1 drop of vehicle into the study eye QID for 14 days. |
| Vehicle | DRUG | 1 drop of vehicle into the study eye QID for 14 days. |
Inclusion Criteria: * Subjects who are candidates for routine, uncomplicated cataract surgery. * Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye. * Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in...
Mapracorat is an investigational small molecule being developed for use in cataract surgery, allergic conjunctivitis, and corneal endothelial cell changes. It is formulated as an ophthalmic suspension to treat ocular inflammation and pain following cataract surgery and to address allergic conjunctivitis.
Mapracorat is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical trials of the ophthalmic suspension in the United States.
Mapracorat is in Phase 3 clinical development for the treatment of ocular inflammation and pain following cataract surgery. It has completed Phase 2 testing for allergic conjunctivitis. The drug is investigational and has not been approved by the FDA.
Mapracorat has completed three clinical trials. Two Phase 3 trials, NCT01230125 and NCT01591161, evaluated the drug for ocular inflammation following cataract surgery. A Phase 2 trial, NCT01289431, tested it in allergic conjunctivitis. All trials were completed in the United States.
Mapracorat is a small molecule immunology therapeutic administered as an ophthalmic suspension. It is designed to reduce ocular inflammation and pain following cataract surgery and to treat allergic conjunctivitis by acting locally in the eye.