Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Aflibercept
Eylea · 2 trials · 1 indication
AE: adverse event SAE: serious adverse event
Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity.
| Arm | Type | Description |
|---|---|---|
| Aflibercept arm | EXPERIMENTAL | No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. |
| Laser photocoagulation arm | ACTIVE_COMPARATOR | No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. |
| Name | Type | Description |
|---|---|---|
| Eylea (Aflibercept, BAY86-5321) | DRUG | Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection. |
| Laser photocoagulation | PROCEDURE | Treatment administered in 20090. Transpupillary conventional laser ablative therapy |
Inclusion Criteria: * Subject was treated in Study 20090 * Age less than 13 months of chronological age * Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in th...
Aflibercept is an investigational ophthalmology drug being developed for multiple eye conditions, including neovascular glaucoma, macular edema, retinopathy of prematurity, and neovascular age-related macular degeneration. It is currently in Phase 2 clinical development for these indications.
Aflibercept is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various ophthalmic conditions.
Aflibercept is currently in Phase 2 clinical development. While some completed trials were Phase 3 studies, the drug's overall development stage is Phase 2 for its current indications. It is investigational and has not been approved by regulatory authorities.
Aflibercept has been studied in several clinical trials, including NCT02396316 and NCT03639675 for neovascular glaucoma in Japan, NCT04015180 for retinopathy of prematurity, and NCT04126317 for neovascular age-related macular degeneration. These trials have been completed, with a total enrollment of 276 patients across all studies.
Yes, Aflibercept is also known as Aflibercept 8 mg. This alternative name refers to the specific dosage strength being investigated in clinical trials. Patients and healthcare providers may encounter either name when referring to this drug.
Yes, Aflibercept has received Priority Review designation from the U.S. Food and Drug Administration. This designation is granted to drugs that may offer significant improvements in safety or effectiveness for serious conditions, potentially expediting the review process.