Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nepafenac, 0.1% · 1 trial · 1 indication
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 |
|---|---|---|
| NEVANAC | EXPERIMENTAL | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. |
| Nepafenac Vehicle | PLACEBO_COMPARATOR | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Nepafenac ophthalmic suspension vehicle | OTHER | 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: * Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Central subfiled macular thickness greater than or equal to 25...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
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.