Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
enVista · 1 trial · 2 indications
Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.
| Arm | Type | Description |
|---|---|---|
| enVista | EXPERIMENTAL | enVista One-Piece Hydrophobic Acrylic Intraocular Lens |
| Name | Type | Description |
|---|---|---|
| enVista | DEVICE | One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery. |
Inclusion Criteria: * Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. * Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in...
enVista is an intraocular lens used in patients with aphakia, the absence of the natural lens of the eye. It is designed for implantation in subjects undergoing cataract extraction to replace the removed natural lens and restore vision.
enVista is developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is responsible for the research, development, and potential commercialization of the product.
enVista is in Phase 3 clinical development. It is an investigational product and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, but the product remains under investigation for its intended use.
enVista has one completed Phase 3 clinical trial with the identifier NCT01230060. The trial, titled 'One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction,' enrolled 122 participants in the United States and included adults aged 18 years and older.
enVista is not FDA approved. It is an investigational product currently in Phase 3 clinical development. The completed Phase 3 trial provides data for regulatory review, but approval status has not been granted.