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 developed by Bausch + Lomb Corporation (ticker BLCO) as an ophthalmic suspension. It is being studied in Phase 3 clinical development for cataract surgery-related ocular inflammation and pain, allergic conjunctivitis, and corneal endothelial cell changes. It is not approved and remains in clinical development.
Mapracorat targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. This target class places it among corticosteroid receptor agonists, and its ophthalmic formulation is designed for local administration to the eye rather than systemic delivery.
Mapracorat is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company has sponsored the clinical trial program evaluating the ophthalmic suspension across cataract surgery, allergic conjunctivitis, and corneal endothelial cell change indications.
Mapracorat is in Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 3 program has focused on ocular inflammation and pain following cataract surgery, with earlier Phase 1 and Phase 2 studies also completed.
Mapracorat has been studied in completed trials including NCT01591655 and NCT01591161, both Phase 3 studies of the 3% ophthalmic suspension for ocular inflammation and pain after cataract surgery. Additional completed trials include NCT01289431 in allergic conjunctivitis and NCT01736462, a Phase 1 corneal endothelial cell density study.
Across the four completed trials, 1,026 participants were enrolled in the studies listed, with a total program enrollment of 1,040. The trials were randomized, double-blind, and placebo-controlled, and all were conducted in the United States.