As it relates to IOLs, a broad spectrum of surgical, technological and pharmaceutical solutions has evolved since the late 1940s, when English physician Sir Nicholas Harold Lloyd Ridley developed and implanted the first IOL.

That evolution continues today with numerous IOLs coming through the pipeline that are soon expected to further support surgeons and their cataract patients. The following summary includes a roundup of multiple companies that are in various stages of new IOL development.

CLAREON TORIC (ALCON)

After launching a collection of Clareon IOLs throughout the United States this past March, including Clareon Monofocal, Clareon PanOptix, Clareon PanOptix Toric, Clareon Vivity and Clareon Vivity Toric, Alcon says the Clareon Toric IOL will be available later this year.

Indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia among adults in whom a cataractous lens has been removed and to correct pre-existing corneal astigmatism, the Clareon Toric IOL will utilize the company’s newest hydrophobic acrylic BioMaterial and advanced manufacturing process.¹ Among the product’s highlights are:

• Hydrophobic acrylic glistenings-free material that delivers among the lowest levels of subsurface nano-glistenings and surface haze^2-4
• Unique, proven STABLEFORCE haptics technology designed for exceptional axial and rotational stability⁵
• Superior axial stability⁵
• Fibronectin that helps to bind the material to the capsule, anchoring the lens in place to help reduce posterior capsule opacification and provide improved stability^5,6
• Broad refractive landing zone, providing functional intermediate vision at 20/32 and maintaining 20/20 visual acuity (VA) at distance
• Consistent delivery of functional intermediate visual acuity (20/32 at 26 inches) while maintaining 20/20 at distance
• Ensured accuracy in astigmatism correction
• Mean absolute rotation of 1.8° at day 1 post-op and 2° at 6 months post-op (n=124).

MODULAR DUAL-OPTIC PRESBYOPIA CORRECTION IOL (ATIA VISION)

This presbyopia-correcting, dual-optic IOL features a shape-changing, fluid-filled base and fixed power front optic that can be chosen to meet each patient’s target refraction. Designed to be responsive to natural accommodative demand, the dual lens system aims to provide a dynamic power response for clear vision from far to near.

The lens is implanted using conventional surgical techniques, enabling physician control while maintaining clinical workflow. The accommodating base lens fits into the capsule bag, and each patient’s fixed power lens is docked to the base. The dual lens system is also designed to:

• Be responsive to the ciliary muscles, and
• To simulate the natural accommodative mechanism of the eye, aiming to restore the full range of functional vision.

According to officials with Atia Vision, upcoming clinical data will be available by early 2023.

ENVISTA TRIFOCAL IOL (BAUSCH + LOMB)

A prospective, multicenter, randomized, active-controlled Phase 3 clinical study is currently underway to evaluate the safety and effectiveness of this hydrophobic acrylic trifocal IOL, which will reportedly offer features that are consistent with the existing enVista IOL family.

The multicenter trial includes more than 500 subjects undergoing bilateral cataract surgery who will receive either the enVista trifocal or enVista monofocal lens, according to the company. Investigators will then determine efficacy endpoints after 6 months and safety endpoints after 12 months based on post-surgical observations. Trial results are expected to determine the specific attributes of this investigational lens. The study is intended to support a pre-market approval (PMA) application filing with the FDA.

Additionally, Bausch + Lomb officials said the company is developing several extended depth of focus (EDOF) IOL candidates that are in earlier phases of research and development.

“We anticipate that both the trifocal and EDOF technologies will also be available in toric versions,” said Anthony Wallace, vice president and general manager for Bausch + Lomb U.S. Surgical. “Our goal is to provide physicians and their patients with as many options as possible to meet their individual needs.”

JUVENE IOL (LENSGEN)

Officials at LensGen have released the results of their Grail Study, a 12-month trial of this modular, shape-shifting, fluid-optic IOL that examined the outcomes and quality of care among 42 subjects (58 eyes). Notable results include:

• 20/20 (range, –0.01 to 0.02) mean monocular corrected distance VA at 12 months
• 20/25+ (range, 0.05-0.10) mean distance-corrected intermediate VA at 12 months
• 20/32-2 (range, 0.21-0.27) mean distance-corrected near VA at 12 months.

At 24 months, 27 eyes were recalled for further evaluation (some patients were lost to follow-up for such reasons as being unwilling to return during the COVID-19 pandemic, being out of contact and failure to appear at scheduled appointments). Additionally, two eyes were discontinued prior to the 12-month visit due to adverse events that were non-IOL related, and two subjects died before the 24-month visit due to non-IOL reasons.

Comparison of the 24-month data with the full cohort of 12-month data revealed no change in contrast sensitivity, an encouraging detail according to LensGen officials. There was also no change in the rate of dysphotopsia.

Additionally, 25 eyes examined with monocular distance-corrected defocus curves found a visual acuity better than 20/40 from approximately +1.50 D to -2.00, while eight subjects examined with binocular distance-corrected defocus curves found a visual acuity better than 20/40 from approximately +2.00 D to -2.50. Also, binocular summation yielded better acuities even when considering the small sample size. Patients are expected to be evaluated again at 36 months.

The lens’ shape-change mechanism allows for a much larger change in focal length than axial movement, according to LensGen. A change in shape of the young crystalline lens can provide up to 17 D of power change, and large axial movement of even 1 mm within the eye provides only about 1 D of power change.

The novel biomimetic design mimics the shape and volume of the natural lens while:

• Preserving ocular physiology
• Optimizing IOL stability
• Mitigating posterior capsule opacification, and
• Promoting hyaloid face stability.

RAYONE (RAYNER)

Rayner announced the approval of an investigative device exemption for both of its fully preloaded capsular-bag RayOne trifocal IOLs. The resulting prospective, randomized, active-controlled trial will reportedly be conducted in 16 U.S. sites to evaluate the safety and efficacy of the implants. Both feature a diffractive design technology that has been developed to secure no more than 11% light loss.

The company has also released the first set of data for its globally registered RayOne EMV (RAO200E) monofocal aspheric IOL, which has reportedly been shown to enable broad depth of focus and provide advantages that are common with monofocal IOLs, such as excellent distance vision, minimal dysphotopsia, high contrast and quality of vision.⁷ Benefits common with multifocal IOLs, such as good near and intermediate vision,⁸ have also been reported for this lens.⁷

The lens adds spherical aberration to the eye to increase depth of focus when compared to traditional monofocal lenses⁹ while avoiding a significant drop in modulation transfer function for far vision. This provides full compliance with the ISO standard for monofocal lenses. With modulation of controlled positive spherical aberration and with the use of monovision, this lens has the potential to further improve depth of focus without compromising distance vision, according to the results of an ongoing prospective multicenter study at Clinica Baviera-AIER Eye Hospital Group in Spain. Recent interim data from a prospective trial have also shown that using a -1.00 D target in the nondominant eye has resulted in 100% of patients reporting spectacle independence for intermediate and distance with 29% patients not requiring glasses for near-sight tasks. All patients reported being satisfied and 86% claimed no difficulty driving at night.⁷

A new member of the company’s IOL pipeline will also be launched during the fourth quarter of 2022 in the European Union — the RayOne EMV Toric (RAO210T) monofocal aspheric toric. This lens reportedly inherits the stability of the RayOne platform¹⁰ and combines RayOne EMV’s optimized positive spherical aberration profile and newly added range of cylindrical powers to enable correction of astigmatism while continuing to deliver broad depth of focus, excellent distance and intermediate vision, minimal dysphotopsia and quality of vision.¹⁰ The company is organizing a safety and performance clinical trial to support a future PMA approval. OM

REFERENCES

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2. Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019;45:1490-1497.
3. Oshika T, Fujita Y, Inamura M, Miyata K. Mid-term and long-term clinical assessments of a new 1-piece hydrophobic acrylic IOL with hydroxyethyl methacrylate. J Cataract Refract Surg. 2020;46:682-687.
4. Maxwell A, Suryakumar R. Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. Clin Ophthalmol. 2018;12:2031-2037.
5. Lane S, Collins S, Das KK, et al. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg. 2019;45:501-506.
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7. Llovet-Osuna F, Llovet-Rausell A, Navalón-Tolosa J, et al. First report of a prospective clinical study of the RayOne EMV: visual outcomes with an enhanced monofocal intraocular lens. White paper: Interim Analysis. Spain, 2022.
8. Schallhorn JM, Pantanelli SM, Lin CC, et al. Multifocal and accommodating intraocular lenses for the treatment of presbyopia: a report by the american academy of ophthalmology. Ophthalmology. 2021;128:1469-1482.
9. Barrett GD. Closing the distance. The Ophthalmol. Feb. 1, 2022. https://theophthalmologist.com/subspecialties/closing-the-distance . Accessed Jul. 27, 2022.
10. Bhogal-Bhamra GK, Sheppard AL, Kolli S, Wolffsohn JS. Rotational stability and centration of a new toric lens design platform using objective image analysis over 6 months. J Refract Surg. 2019;35:48-53.