Rayner is kicking off the week with a major announcement—the FDA has granted approval for its RayOne EMV toric intraocular lens (IOL).
This news coincides with the 2025 American Academy of Ophthalmology’s (AAO) annual meeting, taking place in Orlando, Florida, Oct. 18-20.
First, a look at Rayner.
The British ophthalmic medical product manufacturer boasts a broad portfolio: ophthalmic viscosurgical devices (OVDs), eye drops, artificial tears, and IOLs, including:
- Monofocal
- Trifocal
- Toric
When did we last hear from this company?
Earlier this year—February 2025, to be exact. That’s when Rayner completed patient enrollment for a U.S.-based clinical study on its artificial intelligence (AI)-based, first-ever spiralized IOL: the RayOne Galaxy.
- Of course, this was prefaced by that IOLs introduction to the commercial space in August 2024.
- See all recent coverage on this company by clicking here.
Now to this latest IOL.
Before we get to that, it’s important to note that the lens is Rayner’s latest addition to its EMV IOL platform, which originally launched in 2020 and has since been distributed to 75+ countries across the globe (the United States included).
- The EMV platform’s origins: This was developed in collaboration with Australian consultant ophthalmic surgeon Graham Barrett, AM, MBBCh, FRANZCO.
And in the U.S.: The original RayOne EMV was approved by the FDA in 2021.
Give me some general details on the RayOne EMV.
Based on a patented (truly) non-diffractive optic design, the RayOne EMV IOL:
- Intentionally incorporates controlled positive spherical aberration
- Spreads light along the visual axis to elongate the focal range from distance into intermediate (with a smoother transition between the two)
- This differs from other enhanced monofocal IOLs, which largely use negative spherical aberration
- Spreads light along the visual axis to elongate the focal range from distance into intermediate (with a smoother transition between the two)
- Provides an increased range of focus
- Delivers up to 1.5 diopters (D) with an emmetropic target
- This range can be further extended by customizing the offset, enabling enhanced monovision outcomes
- Is fully preloaded
- Translation: The IOL comes ready in an injector system for a more simplified implantation
So how else does it differ from other monofocal IOLs?
Rayner’s EMV IOL does not use light-splitting technology (which increases depth of focus).
Plus: It’s also designed to extend the range of vision beyond that of a standard monofocal IOL—all while minimizing visual disturbances (compared to diffractive IOLs).
- See here for a look at how it works.
Interesting … now to the new toric IOL.
The RayOne EMV Toric is a single-piece, injectable, preloaded IOL delivered through a 2.2 mm incision.
- Its composition: Is made of a hydrophilic acrylic copolymer (dubbed Rayacryl) with a refractive index of 1.46 as well as a benzophenone-based ultraviolet (UV)-absorbing agent.
Let’s talk lens technology.
The toric IOL is equipped with:
- Anti-vaulting haptic technology for centration and stabilization
- Average offset is just 0.08 mm at 3 to 6 months post-surgery
- A square edge design with a 360° optimized barrier to reduce epithelial cell migration (at the haptic-optic junction and reduce posterior capsular opacification (PCO)
And how does it compare to the original RayOne EMV?
While both the RayOne EMV and EMV Toric IOLs feature the same core optic design, their functionalities are unique in how they correct astigmatism.
- For the RayOne EMV Toric, as Rayner noted: This optical design delivers high-quality vision, with monofocal levels of contrast sensitivity and low dysphotopsia.
Plus: The toric lens is available in various spherical powers, incorporating a range of cylinder correction options to treat significant corneal astigmatism.
- Its cylinder power range: +0.75 D to +4.5 D, in +0.75 D increments
Go on …
Further: The toric IOL includes alignment marketings and a design that emphasizes rotational stability—with a reported average rotation of ~1.83° at 3–6 months post-surgery and very low decentration.
- To note: Rotational stability for the original RayOne EMV is less critical, as there is no cylinder axis to maintain.
Check out this chart comparison of both lenses.
So what supporting clinical data is available on it?
That would be results from a U.S.-based, multicenter, randomized, active-controlled clinical trial conducted as an FDA-cleared investigational device exemption (IDE) study.
- See here for details on why this study was needed (hint: it has to do with collecting safety and effectiveness data).
About this study: The trial enrolled 238 patients who were implanted with either the:
- RayOne EMV Toric IOL
- Monofocal IOL (the control; RayOne Aspheric IOL)
And those results?
Postop data showed that at Day 1 and 2, the toric IOL demonstrated “an absolute mean rotation of just 0.9°,” according to Rayner.
- By Month 6, the IOL showed an “absolute mean lens alignment of only 3.5°, with at least 99% of eyes rotating ≤5°—which, take note, exceeded the FDA’s requirements.
Which means …
Based on this data, Rayner reported that the results confirmed the toric IOL’s “exceptional rotational stability” as well as supported both effective visual performance and reliable astigmatism correction.
- As an aside: Check out this real-world feedback on the IOL from clinicians in Europe (where the toric lens received a CE mark in 2022).
Nice! So … is it too early to ask about commercial availability?
Not at all. In fact, attendees of AAO will have a chance to see the RayOne EMV Toric IOL for themselves—just stop by the Rayner booth.
Otherwise, click here to learn more about access options.