Bausch + Lomb Corporation announced that the FDA has approved its enVista Envy full range of vision intraocular lens (IOL)—less than 5 months after the lens was granted regulatory approval in Canada.
Let’s start with enVista.
First things first: the enVista IOL product line is one of B+L’s IOL brand platforms encompassing monofocal and toric hydrophobic acrylic IOLs.
- Note: In October 2023, the company launched the enVista Aspire monofocal and toric IOLs with intermediate optimized (IO) optics.
What makes these lenses unique is the use of two components:
- Aberration-free optics
- Distinct lens designs for stable performance, predictability, and visual acuity
And how is this enabled?
Most notably, via the company’s proprietary technologies and features:
- TruSight Optic
- Creates a glistening-free material 25x harder than standard hydrophobic acrylic lenses for increased scratch resistance
- StableFlex technology
- Enables controlled and efficient unfolding to enhance optic recovery
- SureEdge design
- Includes a 360° posterior square edge and micro-grooved peripheral edge to reduce edge glare
- Plus: Has the potential to prevent posterior capsular opacification (versus round edge designs)
- AccuSet Haptics
- Allows for extensive interaction with the capsular bag to help secure (manipulate) the lens position
Zero in on this new lens.
B+L’s latest enVista addition is designed to offer a “continuous range of vision with excellent dysphotopsia tolerance” for cataract patients.
Key to providing this performance is the use of Active Sync Optic intelligent energy distribution, intended to optimize vision in all lighting conditions (see the clinical data on it).
Plus: The company’s ClearPath technology, which reduces light scattering.
And what is it intended to treat?
Per B+L, the IOL simultaneously corrects:
- Presbyopia
- Astigmatism
- Lowest available cylinder treatment (1.25 D at IOL plane)
- Highest available cylinder treatment (5.75 D at IOL plane)
- Half-step cylinders (up to 3.5 D at IOL plane)
And its indications?
Two indications include:
- enVista Envy hydrophobic acrylic IOL
- Indication: Primary implantation in the capsular bag of the eye for visual correction of aphakia (< 1.0 D preoperative corneal astigmatism following cataractous lens removal to mitigate effects of presbyopia)
- Target: adult patients
- enVista Envy toric hydrophobic acrylic IOL
- Indication: Primary implantation in the capsular bag of the eye for visual correction of aphakia and corneal astigmatism following cataractous lens removal to mitigate effects of presbyopia
- Target: adult patients
For both indications, this implantation and removal are done by “providing improved intermediate and near visual acuity (VA), while maintaining comparable distance (VA) to an aspheric monofocal IOL.”
Now to support these indications: What’s the clinical data on this lens?
The FDA’s approval is based on the lens’s “excellent long-term outcomes” from a multicenter, randomized, and controlled clinical trial, according to the company.
- The details: Out of 332 participants, 86% reported little to no bothersomeness for dysphotopsia (glare, halo, starbursts)—with “an impressive tolerance profile overall.”
Any others?
While not used for the product’s U.S. approval, its Canadian clearance referenced supportive findings from a prospective, multicenter, randomized, masked, and controlled clinical trial.
The details: Out of 160 participants (aged ≥18; 110 implanted with enVista Envy) with clinically significant bilateral cataract:
- 93% reported little to no bothersomeness for dysphotopsia indicating an “impressive tolerance profile overall”
- 94% had “little to no difficulty viewing close objects”
See here for more findings.
Does this data support the Envy toric IOL as well?
Notably, the company stated that, while the lens “has not been evaluated in a clinical study,” the enVista toric platform has been clinically studied and shown to deliver “proven rotational stability through 180 days post-surgery.”
Further, the benefits of a toric IOL are noted to include:
- Reducing the need for additional refractive correction procedures
- Providing greater accuracy and range than corneal-incision and limbal-relaxing procedures
Any reason for caution?
With no specifically-targeted clinical data for the Envy toric IOL, B+L noted that, generally speaking, “astigmatism that is corrected with a higher cylinder power IOL can result in clinically significant residual astigmatism.”
Further: The effect of this at varying visual distances (distance, intermediate, and near) was reportedly studied in a clinical trial of patients who received implants of non-toric enVista Envy IOLs and were induced with cylinder power to simulate various levels of residual astigmatism.
- The company stated: “If a secondary surgical intervention is necessary to reposition the IOL, explantation should be considered as some patients may have recurrent or persistent issues related to rotational instability and misalignment.”
Click here for a list of warnings/precautions for both versions of the Envy IOL.
Duly noted. Lastly, when will this lens be available?
To start, commercial availability in the U.S. will be “on a limited basis,” B+L noted.
The company stated that the commercial launch will begin in the coming weeks, with the IOL being available more broadly in 2025.