Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nepafenac, 0.3% · 7 trials · 2 indications
BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.
Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.
Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (\>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.
Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (\> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.
Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (\> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.
| Arm | Type | Description |
|---|---|---|
| Nepafenac | EXPERIMENTAL | With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery. |
| Vehicle | PLACEBO_COMPARATOR | With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery. |
| Placebo | PLACEBO_COMPARATOR | Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery. |
| Nepafenac 0.3% | EXPERIMENTAL | Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery. |
| NEVANAC | ACTIVE_COMPARATOR | Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. |
| Nepafenac Vehicle 0.3% | PLACEBO_COMPARATOR | Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery. |
| NEVANAC Vehicle | PLACEBO_COMPARATOR | Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. |
| Acular | ACTIVE_COMPARATOR | - |
| Nepafenac 0.1% | ACTIVE_COMPARATOR | Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery. |
| Name | Type | Description |
|---|---|---|
| Nepafenac Ophthalmic Suspension, 0.3% | DRUG | Test intervention |
| Nepafenac vehicle | OTHER | Inactive ingredients used as placebo comparator |
| Prednisolone acetate | DRUG | 1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks |
| Vehicle | OTHER | Inactive ingredients used as placebo comparator |
| Nepafenac Ophthalmic Suspension, 0.1% | DRUG | Topical ocular administration |
| Nepafenac Vehicle Ophthalmic Solution | OTHER | Inactive ingredients used as placebo; topical ocular administration |
| Nepafenac Ophthalmic Suspension 0.3% Vehicle | OTHER | Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery. |
| NEVANAC Vehicle | OTHER | Nepafenac vehicle, one drop in affected eye three times daily, for 16 days |
| Nepafenac ophthalmic solution 0.1% | DRUG | 1 drop 4 times daily for 90 days |
| Ketorolac Tromethamine ophthalmic solution 0.4% | DRUG | 1 drop 4 times daily for 90 days |
| Nepafenac ophthalmic suspension vehicle | OTHER | - |
| Nepafenac Vehicle 0.3% | OTHER | Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery. |
Inclusion Criteria: * Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens; * History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye; * Best corrected visual acuity (BCVA)...
Nepafenac 0.1% is an investigational small molecule being studied for use in ophthalmology, specifically for macular edema, cataract, and non-proliferative diabetic retinopathy. It is an eye drop suspension that has been evaluated in clinical trials for these conditions.
Nepafenac 0.1% is being developed by Alcon Inc., a company traded on the stock exchange under the ticker symbol ALC. Alcon is the developer of this investigational ophthalmology drug.
Nepafenac 0.1% is in Phase 2 clinical development. While some completed trials were Phase 3, the drug is currently listed as being in Phase 2. It is investigational and not approved, as it remains in clinical development.
Nepafenac 0.1% has been studied in five clinical trials, all completed, with a total enrollment of 4,138 participants. Key trials include NCT00405730, comparing Nepafenac to ketorolac and placebo in cataracts, and NCT01318499, a Phase 2 study in cataract patients.
Nepafenac 0.1% and Nepafenac 0.3% are different concentrations of the same drug. The 0.3% formulation was studied in a Phase 2 trial (NCT01318499) for cataract, while the 0.1% concentration is the focus of this profile.