Bausch + Lomb Corporation announced that Health Canada has granted regulatory approval for the enVista Envy full visual range intraocular lens (IOL)—a first step toward acceptance in North America.
Let’s begin with enVista … what is it?
B+L’s enVista brand platform comprises both monofocal and toric hydrophobic acrylic IOLs featuring two main differences from other lenses:
- Aberration-free optics
- Distinctive lens design for stable performance, predictability, and visual clarity
- Key to this:
- AccuSet Haptics enables extensive interaction with the capsular bag to aid in securing the lens position
- TruSight Optic offers glistening-free material 25x harder than standard hydrophobic acrylic lenses for increased scratch resistance
- StableFlex technology allows for controlled and efficient unfolding to enhance optic recovery
- SureEdge design with a 360° posterior square edge and a micro-grooved peripheral edge to reduce edge glare
- Also has the potential to prevent posterior capsular opacification (vs round edge designs)
- Key to this:
Wait just a minute … didn’t the company just launch another enVista lens?
It did! About 7 months ago.
Back in October 2023, B+L announced the U.S. commercial launch of the enVista Aspire monofocal and toric iOLs with intermediate optimized (IO) optics.
See here for our coverage on that lens (including a special interview with B+L Surgical’s Anthony Wallace, vice president and general manager).
And any other enVista lenses to know about?
See details on the enVista IOL family here, which include:
- MX60E, MX60PL (monofocal)
- MX60ET, MX60PT (toric)
Go on …
Fun fact: Based on B+L’s Q1 2024 financial results, its premium IOL products have seen a 30% growth compared to Q1 2023.
This is due in part to the early commercial launch of the enVista Aspire IOL.
Alrighty, now talk about the enVista Envy.
Per B+L, this latest installment provides a “full range of vision with excellent dysphotopsia tolerance” and features the following proprietary technology:
- ActivSync Optic Intelligent Energy Distribution
- Designed to optimize vision in all lighting conditions
- ClearPath technology
- For reducing light scattering
- Low-Cyl toric technology
- Enables the Envy toric lens to treat presbyopia at the same time as well as low amounts of astigmatism (0.9D IOL Plane - Canada) with 0.5D steps (or less) of precision throughout the cylinder range
And which patients is this lens for?
Ideally, those undergoing cataract surgery (plus, see above for details on presbyopia and astigmatism).
Any clinical data to support its use?
Yes! The company referenced a prospective, multicenter, randomized, masked, and controlled clinical trial that enrolled 160 participants (aged ≥18) with clinically significant bilateral cataract.
They were randomized 2:1 to receive implantation of either:
- enVista Envy IOL (n = 110)
- enVista monofocal IOL (n = 50)
The findings: B+L reported that excellent long-term outcomes were associated with the use of the Envy IOL.
More specifically, an average of 93% of participants “reported little to no bothersomeness for dysphotopsia (glare, halo, starbursts),” indicating an “impressive tolerance profile overall,” B+L stated.
How were patients’ vision following implantation?
B+L also reported that 94% of participants had “little to no difficulty viewing close objects.”
Even further: That same percentage also reported having excellent distance vision (spectacle-free) following surgery—with 4 D of continuous visual range.
Plus: Binocular uncorrected visual acuity (UNVA) and uncorrected intermediate visual acuity (UIVA) of 20/32 or better were achieved in 93% and 97% of enVista Envy eyes, respectively.
Nice! And when will this lens be available?
Commercial availability is expected by mid-June (in Canada only, keep in mind).
What about the United States?
The company stated that it’s currently seeking approval in other markets, including the U.S. and Europe.
In other words: It’s still pending FDA approval.
Is there a timeframe for that?
Great question … we’ll keep you posted.