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Also known as Nepafenac Ophthalmic Suspension, 0.3%, Nepafenac ophthalmic suspension, 0.1% (NEVANAC), Nepafenac, 0.1%, Nepafenac ophthalmic solution 0.1%, Nepafenac 0.1%, Nepafenac Ophthalmic Suspension, 0.1%
Nepafenac, 0.3% · 9 trials · 4 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.
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
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.
Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).
| 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 | - |
| Ketorolac Trometamol | ACTIVE_COMPARATOR | One drop in the study eye 3 times daily for 23 days |
| Nepafenac Vehicle | PLACEBO_COMPARATOR | One drop in the study eye 3 times daily for 23 days |
| 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 1mg/ml eye drops, suspension | DRUG | One drop in the study eye 3 times daily for 23 days |
| Ketorolac Trometamol 5 mg/ml eye drops, solution | DRUG | One drop in the study eye 3 times daily for 23 days |
| Nepafenac vehicle eye drops | OTHER | One drop in the study eye 3 times daily for 23 days |
| 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. |
| Nepafenac ophthalmic suspension, 0.1% (NEVANAC) | DRUG | 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery. |
| Prednisolone acetate ophthalmic suspension (OMNIPRED) | DRUG | One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery. |
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, 0.3% is an ophthalmic suspension formulation of nepafenac, a small molecule nonsteroidal anti-inflammatory drug. It is being developed by Alcon Inc. (ticker ALC) for eye conditions including cataract surgery, macular edema, and non-proliferative diabetic retinopathy. It is a higher-concentration version of the 0.1% nepafenac ophthalmic suspension.
Nepafenac, 0.3% is being studied for cataract, macular edema, and non-proliferative diabetic retinopathy. Clinical trials have evaluated it for ocular pain and inflammation after cataract surgery and for macular edema in patients with non-proliferative diabetic retinopathy undergoing cataract surgery. It is an investigational ophthalmic anti-inflammatory therapy.
Nepafenac, 0.3% targets PTGS2 (cyclooxygenase-2) and PTGS1 (cyclooxygenase-1). It acts as an inhibitor of these enzymes, which are involved in prostaglandin synthesis and the inflammatory response in ocular tissue. This mechanism underlies its use for pain and inflammation in the eye.
Nepafenac, 0.3% is developed by Alcon Inc., which trades under the ticker ALC. Alcon is an ophthalmology-focused pharmaceutical and device company. The 0.1% nepafenac ophthalmic suspension is marketed under the brand name NEVANAC.
Nepafenac, 0.3% is in Phase 3 development. Five clinical trials have been completed, including Phase 3 studies in macular edema and cataract, and no active trials are currently listed. It is an investigational product and is not described as FDA approved in the available development record.
Completed trials include NCT01872611 and NCT01853072, Phase 3 studies of once-daily nepafenac for macular edema in non-proliferative diabetic retinopathy and cataract, and NCT01426854, a Phase 3 study of nepafenac versus placebo for ocular pain and inflammation in cataract. NCT01318499 was a Phase 2 cataract study.
Nepafenac, 0.3% is a higher-concentration ophthalmic suspension of nepafenac, while NEVANAC is the brand name for nepafenac ophthalmic suspension, 0.1%. Both contain the same active ingredient, nepafenac, but at different strengths. Other names include nepafenac ophthalmic suspension 0.1% and nepafenac 1 mg/mL eye drops.