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Grace Koennecke is an Editorial Intern for MJH Life Sciences.

The European Medicines Agency's new standard procedure allows manufacturers to request advice from medical device expert panels

EMA launches procedure for manufacturers working with high-risk medical devices

OCU400 is the first gene therapy from the biotechnology company to move forward into Phase 3 with a broad retinitis pigmentosa (RP) indication

Ocugen, Inc. receives European Medicines Agency ATMP designation for new gene therapy 

The lead gene therapy candidate, AXV-101, is expected to enter clinical development in mid-2025

Viralgen and Axovia Therapeutics enter partnership, target retinal dystrophy in Bardet-Biedl Syndrome

The scientific outputs from MACUSTAR’s study could impact more than 200 million patients with AMD globally

MACUSTAR receives additional EMA support for AMD clinical study

The updated device is designed to meet market diagnostic needs, including within geographic atrophy research

 iCare announces updated MAIA TrueColor Microperimetry System

The company, which has European headquarters in Basel, Switzerland, plans to use the funds for a non-interventional, observational study and a first-in-human clinical trial

RhyGaze announces $86 million in Series A financing for optogenetic vision restoration therapy candidate

The ALLY Adaptive Cataract Treatment System will be the first EU ALLY commercial installation

LENSAR receives certification for new adaptive cataract treatment system

The EMA issued a designation for the small molecule photoswitch, which targets inherited retinal diseases including retinitis pigmentosa

Kiora Pharmaceuticals receives Orphan Medicinal Product Designation for KIO-301 

On 13 January, Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., announced it would partner with Klinge Biopharma GmbH and Formycon AG in commercialising FYB203, Formycon’s biosimilar candidate to aflibercept (Eylea, Regeneron Pharmaceuticals Inc.) in designated regions of Europe.

 On 5 February, Formycon announced that Klinge Biopharma had also concluded an exclusive license agreement with Lotus Pharmaceutical.

 This new agreement will enable commercialisation of the product throughout the Asia-Pacific region. Pending regulatory approval, the product will be marketed under the brand name AHZANTIVE.

Under these agreements, Teva will lead the commercialisation effort in designated regions of Europe, excluding Italy, and in Israel. Lotus Pharmaceutical will lead commercialisation in Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam, as well as within the Special Administrative Region Hong Kong.

Previously, Teva was established as the European commercialisation partner of FYB201, Formycon's biosimilar to ranibizumab (Lucentis). Nicola Mikulcik, hief business officer of Formycon, commented on the expansion of the partnership. “With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio/Ongavia) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field,” she said in the press release.

 “We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product.”

Like its reference product, the biosimilar FYB203 is an anti-vascular endothelial growth factor (VEGF) agent used to treat retinal disease. Chief among those indications is neovascular age-related macular degeneration (AMD), also known as wet AMD.

In November 2024, the European Medicines Agency's Committee for Medicinal Products of Human Use issued a positive recommendation for marketing authorisation of FYB203, under the brand names AHZANTIVE/Baiama. The European Commission is expected to announce a response to the authorisation application in late January 2025.

In June 2024, the US Food and Drug Administration (FDA) approved the biosimilar FYB203, also known as aflibercept-mrbb. In a press release at that time, the company stated3 that FDA approval was rooted in the company's “comprehensive data package” that included “analytical, pre-clinical, clinical and manufacturing data.” The data showed that FYB203 demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference product in patients with neovascular AMD.

Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel. News release. Teva Pharmaceutical Industries Ltd. Published January 13, 2025. Accessed January 13, 2025. https://www.globenewswire.com/news-release/2025/01/13/3008103/0/en/Teva-Announces-Collaboration-to-Commercialize-Formycon-s-Biosimilar-Candidate-to-Eylea-aflibercept-in-major-parts-of-Europe-and-in-Israel.html

Lotus Pharmaceutical becomes strategic partner for the commercialization of Formycon’s Eylea® biosimilar FYB203/AHZANTIVE® in the Asia-Pacific Region. News release. Formycon AG. Published February 5, 2025. Accessed February 5, 2025.

Harp M. FDA approves Formycon’s biosimilar to Eylea, aflibercept-mrbb (Ahzantive). Ophthalmology Times. Published July 2, 2024. Accessed January 13, 2025. https://www.ophthalmologytimes.com/view/fda-approves-formycon-s-biosimilar-to-eylea-aflibercept-mrbb-ahzantive-

The commercialisation agreements for the biosimilar to aflibercept (Eylea) cover Israel, major parts of Europe and the Asia-Pacific Region

Teva partners with Klinge Biopharma, Lotus Pharmaceutical for commercialisation of Formycon’s FYB203 (biosimilar aflibercept)

Over the last 15 years, biosimilars have become a major feature of the health care landscape. Physicians in many disciplines, particularly oncology and immunology, have embraced biosimilars. However, access to educational resources on these powerful biologics can be inconsistent, and in turn, some ophthalmologists who could benefit from the adoption of biosimilars are left in the dark.

The real-world application of biosimilars was the focus of discussion for Martin Zinkernagel, MD, PhD, chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland, and Paolo Lanzetta, MD, professor of ophthalmology and chairman of the Department of Medicine-Ophthalmology at the University of Udine in Italy. In their discussion, the experts addressed several common questions, framed around the phase 3 clinical trial for biosimilar SB11 (BYOOVIZ) from Biogen. SB11 is approved in Europe and the United Kingdom. Like the reference product ranibizumab (Lucentis), SB11 is approved for the treatment of retinal disease including neovascular age-related macular degeneration (nAMD).

Addressing physicians’ levels of familiarity with biosimilars, Dr Lanzetta attributed much of the variation to regulatory discrepancies. “The uptake of biosimilars varies throughout Europe by country and by product,” he said. “Obviously, variation in the uptake of biosimilars [is] influenced by government involvement, reimbursement issues and tender procurement policies.” Recent survey data have revealed gaps in awareness across Europe and in the United States on the efficacy and safety of biosimilars for retinal diseases, Dr Lanzetta said, especially in terms of “real-world data.”

In a clinical application, Dr Lanzetta said, biosimilars may exhibit minor differences from the reference products, but they aren’t considered to have significant impact on the efficacy or safety profile. Typically, the biosimilar and reference medicine must have the same posology and route of administration, with few exceptions, he added.

Dr Lanzetta also said that in the last 10 years, the European Medicines Agency (EMA) has approved the highest number of biosimilars worldwide.

 “And this means, to us physicians, having both the possibility to have experience on their use in terms of safety and evaluating the efficacy after that,” he explained.

One common misconception about biosimilars is that these therapeutics are interchangeable with the idea of generic medicines. But there is a key indicator that biosimilars are unique: the cost. “While generic medicines are marketed at a significantly lower price than name brand ones, why do we not see the same level of cost savings with biosimilars?” Dr Zinkernagel asked.

Dr Lanzetta explained that biosimilars are developed via a rigorous, complex and highly regulated manufacturing process. “Generics are simple chemical medicines or agents, which is not the case for biosimilars and biologics,” he said. “Unlike generics, biologics, and therefore biosimilars as well, are very complex; they’re very difficult to copy. And the development processes are patented and proprietary to the originators.” The proprietary nature of biologic development, he added, is why biosimilars may have differences from their originators.

Prof Zinkernagel and Dr Lanzetta used data from the SB11 phase 3 trial to expand upon the capabilities of biosimilars. Prof Zinkernagel detailed the study: over 700 patients were included in the randomised, double-masked, parallel-group multicentre trial. Over 52 weeks, investigators evaluated the efficacy and the safety profile of this biosimilar SB11 in comparison with monthly ranibizumab for the treatment of nAMD.

“Patients with neovascular AMD were included, [with a] visual acuity range between 20/40 and 20/200,” Prof Zinkernagel said. “[Patients] were randomised in a 1:1 ratio to either have the originator or the biosimilar every 4 weeks from baseline up to week 48.”

Primary end-points were change from baseline in best corrected visual acuity at week 8 and change from baseline in central subfield thickness at week 4. The pre-specified secondary efficacy end-points included longer-term assessments of change from baseline in visual acuity, and the proportion of participants who lost fewer than 15 letters or who gained 15 or more letters in visual acuity from baseline at weeks 24 and 52.

“Other secondary end-points included, of course, change from baseline in central subfield thickness and central retinal lesion thickness at week 24, as well as change from baseline in choroidal neovascularisation [CNV] size and proportion of participants with active CNV leakage seen via OCT [optical coherence tomography] at week 24,” Prof Zinkernagel continued. Describing the results, he said, “When you look at the visual acuity improvements, it’s really equivalent. You have equivalence between the originator and the biosimilar, and the same holds true for a decrease in central retinal thickness. So the curves are basically the same, and also the secondary end-points.”

Prof Zinkernagel also spoke about the immunogenicity outcomes of the SB11 trial, as immunogenicity reactions have been a common problem in past assessments of anti–vascular endothelial growth factor (VEGF) agents. Along with detrimental effects to visual acuity, immunogenicity reactions can also lead to vasculitis and vitritis.

“Now, in this trial, the overall cumulative incidence of anti-drug antibodies, antibodies reacting against this specific drug up to week 52, was very low,” Prof Zinkernagel said. “For the SB11 biosimilar, it was 4.2%, and for the originator it was 5.5%. So very, very similar.”

He also noted that most antibodies were non-neutralising, which generally indicates a weak antibody response. “Furthermore, no statistical or clinically relevant differences in the incidence of anti-drug antibodies and neutralising antibodies were observed between treatment groups at any of the time points,” Prof Zinkernagel explained.

Dr Lanzetta highlighted the unique potentialities for anti-VEGF therapies as an area where physicians can consider treating patients with a biosimilar. “You can either switch a patient from the originator, obviously, or you can also consider treating with a biosimilar treatment-naive patients who may benefit…from being treated with that reference agent or originator agent,” he said. When to deploy a biosimilar will depend on many factors, including the locality where a patient is being treated. “Europe has different countries, different health care systems,” Dr Lanzetta said. “You may consider treating with the biosimilar patients who may not be strictly adherent to the cost of therapy and the frequency of treatment because of some cost issues.”

Just as education on biosimilars is vital to practitioners, awareness and education resources for patients are vital, too. “We spend a lot of time with our patients in letting them know that biologics did undergo a very rigorous approval process through studies, efficacy and safety studies,” Dr Lanzetta emphasised. This education is vital to getting patients on board with biosimilars, and it sparks enthusiasm about the potential benefits. “Once they do understand that, I think they will be very prone to receive a biosimilar; [it’s] in their interest and in the interest of the community, the whole community of patients, and in the interest of the health care system,” Dr Lanzetta said.

1. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency. Updated December 2, 2019. Accessed October 3, 2023. 

https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pd

Editor’s note: A prior version of this article contained a misspelling of the product name BYOOVIZ. It has been corrected. We regret the error.

How biosimilars expand treatment options for patients with retinal disease

For a patient undergoing cataract surgery, the primary post-operative expectation is improved vision. As a surgeon, achieving the desired refractive outcome involves several critical steps: conducting precise preoperative measurements, selecting the appropriate IOL technology and power, and performing surgery with accuracy.

Heidelberg Engineering’s advanced diagnostic imaging solutions support you in enhancing the cataract patient journey, from initial assessment and diagnosis to preoperative planning and postoperative monitoring. Throughout this interactive supplement, leading surgeons share their experiences with and discuss the advantages of these advanced diagnostic imaging solutions, as Dr. James Lewis does in this video 

A major challenge for cataract surgeons is the vast number of patients. Addressing this backlog is crucial to prevent vision impairment and improve the quality of life for those affected. The electronic medical record, Heidelberg Eye Explorer 

, helps to streamline the cataract workflow by optimising patient data management, enhancing communication, and improving surgical planning.

Dr. Hackl from Hanusch Hospital in Vienna recalls how HEYEX EMR streamlined their workflow and provided access to patient records across more than five locations.

“There was a need to have a paperless medical record which could be seen in all five locations and met our main requirements: a continuous medical record, a patient summary for a quick overview, as well as planning and documentation…when a system like HEYEX EMR supports structured data the possibilities to use the data are unlimited." 


Read the full story on how Hanusch Hospital, Vienna, used HEYEX EMR to streamline their workflow.

 image and data management platform into your clinic workflow allows for improved efficiency. All patient information is centrally recorded and can be accessed anywhere in the clinic. Images and data are immediately available on your desired device, viewing station, and in the patient record.

Visualising all relevant data and images from the cataract workup contributes to an optimal diagnostic workflow, facilitates confident decisions, and assists you in easily identifying potential sources of complication.

Precise ocular biometry is critical for determining the power of IOLs being implanted. Leveraging advanced Swept-Source OCT technology, 

 provides you with a comprehensive, all-in-one solution for optical biometry and IOL power prediction. In a single imaging session, the Cataract App provides precise and accurate measurements traditionally delivered by several devices, including axial length, cornea topography and tomography, anterior chamber depth, lens thickness, white-to-white, and central corneal thickness.

“I was looking to upgrade my methods and equipment, especially in intraocular lens calculation, explains Dr Arturo Chayet, ophthalmologist and founder of CODET Vision Institute in Tijuana, Baja California, Mexico. At the time, I was using the IOLMaster500 for calculations, but I was looking for a bridge to swept-source OCT technology. We knew it was crucial to not only measure axial length and various parameters of the eye but also to understand the anterior chamber, specifically the effective lens position. I was struck by the capability of ANTERION and was very impressed with the expertise Heidelberg Engineering has in the field. Our experience with SPECTRALIS was excellent as well.” 
- Dr. Arturo Chayet, M.D. 

Learn more about ‘Biometry for IOL Power Prediction’ in this 

 that provides detailed information on preoperative diagnostics, including corneal maps and biometry parameters relevant for IOL power prediction.

For refractive IOL procedures, where presbyopia-correcting IOLs are implanted, and in challenging cases, accessing additional data is essential for patient selection and satisfaction. ANTERION provides a comprehensive analysis of the cornea and includes details on astigmatism and corneal wavefront. 

Learn more about the significant role ANTERION plays in premium IOL selection here.

ANTERION’s high-resolution imaging of the anterior segment can help you prevent unexpected results by identifying complex ocular properties relating to anatomy, visual quality, and atypical geometry of the anterior segment. The high-quality images also provide visual aids that can be used to explain your patient’s condition and the planned surgical procedure, enhancing their understanding and compliance.

Listen to Dr. Pooja Kumar, Consultant, Khetarpal Hospital, New Delhi, India 

, as she explains how she uses ANTERION’s high-resolution swept-source OCT images to identify complex cases like posterior polar cataracts. She also explains how she utilizes these images to counsel her patients in preparation for surgery.

OCT imaging of the retina before cataract surgery lets you assess pathologies that may limit visual outcomes. 

 allows you to choose between 20kHz, 85kHz and 125KHz depending on your needs. 20 kHz scan speed offers high-quality retinal imaging also in eyes with media opacities often caused by cataracts. 

Read more about the benefits of retinal OCT before cataract surgery here

 provides a comprehensive overview by combining data and images from all devices 

. This consolidated information ensures you have all relevant diagnostic details, enhancing your confidence in surgical planning.

 delivers next-generation image technology to revolutionise your surgical practice. It brings together innovative design and 3D technology to set new standards in surgical precision and surgeon comfort during procedures.

 as he shares his initial impressions and discusses the benefits of SeeLuma, explaining why he eagerly anticipates incorporating it into his practice soon.

High-Resolution Imaging for Postoperative Evaluation

 supports you in visualising the success of surgical procedures by comparing pre- and post-op images and measurements. Detailed anterior chamber information from high-resolution SS-OCT images helps you assess cataract surgery outcomes, including IOL placement, ensuring optimal patient care and satisfaction 

Watch this Healio video interview with Dr. Mitchell W. Dul, OD, 

where he explains how he uses the ANTERION Metrics App to show his patients their pre-op and post-op configurations, helping them become more invested in their care.

Leveraging Heidelberg Engineering's advanced diagnostic tools and technologies, including high-quality OCT imaging, precise biometry, and corneal topography and tomography, enhances your diagnostic accuracy, surgical planning, and postoperative evaluation. Whether dealing with standard, refractive IOL, or challenging cases, these tools and technologies can help you improve patient outcomes and engagement, streamline workflows, and flag potential surgical complications.

Disclaimer: Not all features are available for sale in all countries

Enhancing the Patient Journey: Solutions for Streamlining Success in Cataract Surgery

Multifocal lenses, particularly trifocal IOLs, have been the gold standard for those seeking a full range of vision, especially as more patients adopt active lifestyles. These lenses aim to provide glasses-free vision at near, intermediate, and distance ranges, but they come with limitations, such as visual disturbances due to halos and glare. 

To address this, extended depth of focus (EDOF) lenses were developed to offer good intermediate visual acuity with fewer visual disturbances, while enhanced monofocal IOLs aimed to improve intermediate vision while maintaining high-quality distance vision. Despite these advancements, both EDOF and enhanced monofocal IOLs often fail to provide the comprehensive glasses-free vision that many patients desire, particularly for near tasks. These challenges impact patient satisfaction after surgery.

While trifocal IOLs enhance vision at various distances, many patients report experiencing visual disturbances—such as halos and glare—especially in low-light or night-time conditions. These disturbances, collectively known as dysphotopsia, can vary in subjective severity based on individual tolerance, making it challenging for surgeons to predict the degree of disturbance that each patient may experience. The light-splitting optics in trifocal and in some EDOF IOLs reduce contrast sensitivity, further impairing vision in dim settings. This can impact quality of life, particularly in situations where pupil size is increased, which can exacerbate visual disturbances.

For intolerable dysphotopsia, the traditional treatment algorithm involves a long road of trial and error for patients, starting with an extensive evaluation and management of any concomitant causes of visual disturbance.

 Patients may require glasses or laser refractive surgery for residual refractive error, or laser capsulotomy for posterior capsule opacification. Patients with large pupils may need to administer miotic drops to reduce straylight. If symptoms persist or if symptoms are solely caused by multifocal optics, IOL exchange remains the only solution. While surgery is effective in resolving dysphotopsia, it can be complicated by IOL adhesion to the capsule or prior capsulotomy, which can lead to capsular tears or vitreous loss.

Researchers have tried to understand what factors drive patient satisfaction with IOLs. A study by Schallhorn et al identified several key factors essential for daily activities across different distances, including binocular visual acuity and glare.

The early results of the multicentre RayPRO (Rayner) study presented at the ESCRS 2024 congress conclude that photic phenomena like halos and glare can have a greater influence on satisfaction than the ability to be spectacle independent, and suggest the impact of dysphotopsia on satisfaction may increase over time. This underscores the need for IOL designs that effectively balance a broad range of vision with visual comfort.

Together, these findings suggest that optimal IOL design should address a comprehensive set of patient needs by ensuring sharp vision across different distances and minimising dysphotopsia to enhance overall quality of life. Reducing halos and glare, in particular, is associated with higher satisfaction following IOL implantation. This need has driven innovations in IOLs that deliver comprehensive vision with fewer disturbances.

Recent years have seen significant advancements in the IOL industry,
with a focus on high-quality visual outcomes and minimal side effects. Non-diffractive EDOF IOLs are intended to mitigate dysphotopsia commonly associated with multifocal lenses, though they may provide less sharp near vision.

 Adjustable IOLs, such as light-adjustable lenses (LALs), allow for postoperative fine-tuning,

 while hybrid multifocal lenses combining refractive and diffractive optics are gaining popularity for their balanced visual quality across a broad range.

Enhanced monofocal or monofocal-plus IOLs, such as the Tecnis Eyhance (Johnson & Johnson Vision) and the RayOne EMV (Rayner), represent next-generation alternatives in patients who have higher expectations of visual quality. These non-diffractive IOLs reduce dysphotopsia similarly to conventional monofocal IOLs, while increasing the depth of focus by various mechanisms, including the modulation of refractive power or spherical aberrations across the IOL optic. Intermediate vision is enhanced while achieving good distance vision, which provides functional vision for most daily activities.

 The near vision performance of enhanced monofocal IOLs can be further improved with the use of monovision.

 Accommodating IOLs that can change their shape and power similar to the natural crystalline lens are being investigated but they remain experimental at present.

The RayOne Galaxy IOL introduces a new solution as the world’s first spiral IOL, designed with artificial intelligence to deliver high visual quality across a full range of vision, while minimising dysphotopsia, especially in low-light conditions. Unlike traditional trifocal or EDOF lenses that use diffractive or aspheric optics, the RayOne Galaxy features a unique non-diffractive spiral optic design. The non-diffractive spiral progressively elongates focus, creating a smooth and continuous variation in optical power along the defocus curve, with maximum light transmission to the retina. By enhancing visual clarity and minimising disturbances, the RayOne Galaxy shows promise for improving patient satisfaction after implantation.

The Vision Scotland team staff were some of the first surgeons in the world to implant the RayOne Galaxy. We collaborated with colleagues in a multicentre evaluation to assess the new spiral IOL’s performance in real-world settings. This evaluation spanned 10 clinics, each including 10 patients eligible for bilateral premium IOL implantation (RayOne Galaxy and RayOne Galaxy Toric). 

We assessed visual acuity, subjective refraction and the defocus curve, and used a halo and glare simulator, with follow-ups at 1 and 3 months postoperatively. Early outcomes from the evaluation show high patient satisfaction, and good uncorrected and corrected monocular vision across all distances (39 patients at 1-month postoperative follow-up):

Distance vision: 0.09 logMAR (uncorrected), –0.01 logMAR (distance-corrected)

Intermediate vision: 0.07 logMAR (uncorrected and distance-corrected)

Near vision: 0.12 logMAR (uncorrected), 0.10 logMAR (distance-corrected)

Binocular vision outcomes were equally satisfactory:

Distance vision: 0.02 logMAR (uncorrected), –0.04 logMAR (distance-corrected)

Intermediate vision: 0.01 logMAR (uncorrected and distance-corrected)

Near vision: 0.06 logMAR (uncorrected), 0.04 logMAR (distance-corrected)

One month postoperatively, both sphere and cylinder decreased, with near-emmetropic subjective refraction (manifest refractive spherical equivalent –0.33 ± 0.32). The binocular defocus curve showed visual acuity better than 0.2 logMAR across a range of nearly 4.0 D, with a smooth plateau from +0.5 D to –2.5 D. This defocus profile contrasts with the wave-like pattern typically seen in trifocal IOLs (

Vision simulator tests revealed fewer halos and less glare compared with published data on diffractive trifocal IOLs,

 consistent with a preclinical study by Amon et al (presented at ESCRS 2024).

 This study used the Real Artificial Lens Vision (RALV) device to compare the RayOne Galaxy (spiral IOL), RayOne Trifocal, and RayOne EMV (enhanced monofocal IOL). 

The results indicated that the RayOne Galaxy IOL provided an extended visual range comparable to a trifocal IOL, with better contrast sensitivity than diffractive trifocals and significantly fewer halos, with halo size closer to enhanced monofocals.

In our clinical evaluation, one-third of patients reported no halos, and 74% reported no glare. Among those who did experience visual symptoms, most described them as mild (

As cornea and refractive surgeons, we find the early outcomes with the RayOne Galaxy IOL incredibly promising, particularly in how it enhances quality of life by balancing sharpness of near, intermediate, and distance vision with reduced halos and glare. This feature directly addresses a common patient concern: achieving spectacle independence without compromising night vision quality, which has often been an issue with multifocal IOLs. 

Our team would recommend this lens for patients with active lifestyles who need reliable vision across all distances and are sensitive to visual artefacts. The spiral design’s unique approach to reducing dysphotopsias makes this lens a good alternative for presbyopia-correcting IOLs, offering high-quality, full-range vision and visual comfort.

The growing demand for multifocal lenses, particularly trifocal IOLs, underscores their potential to provide a full range of vision, though visual disturbances can impact patient satisfaction. The RayOne Galaxy IOL addresses these challenges with its novel non-diffractive spiral design, which minimises halos and glare while delivering excellent visual outcomes and a smooth, full range of vision. Early clinical results from our ongoing evaluation suggest that patients achieve clear vision across different distances with reduced visual disturbances.

1. Modi S, Lehmann R, Maxwell A, et al. Visual and patient-reported outcomes of a diffractive trifocal intraocular lens compared with those of a monofocal intraocular lens. 

. 2021;128(2):197-207. doi:10.1016/j.ophtha.2020.07.015

2. Fernández J, Alfonso Sánchez JF, Nieradzik M, Valcárcel B, Burguera N, Kapp A. Visual performance, safety and patient satisfaction after bilateral implantation of a trifocal intraocular lens in presbyopic patients without cataract. 

 2022 Aug 10;22(1):341. doi: 10.1186/s12886-022-02556-y. PMID: 35948879; PMCID: PMC9364506.

3. de Vries NE, Webers CA, Touwslager WR, et al. Dissatisfaction after implantation of multifocal intraocular lenses. 

2011 May;37(5):859-65. doi: 10.1016/j.jcrs.2010.11.032. Epub 2011 Mar 11. PMID: 21397457.

4. Mencucci R, Favuzza E, Caporossi O, Savastano A, Rizzo S. Comparative analysis of visual outcomes, reading skills, contrast sensitivity, and patient satisfaction with two models of trifocal diffractive intraocular lenses and an extended range of vision intraocular lens. 

 2018 Oct;256(10):1913-1922. doi: 10.1007/s00417-018-4052-3. Epub 2018 Jul 6. PMID: 29980919.

5. S Woodward MA, Randleman JB, Stulting RD. Dissatisfaction after multifocal intraocular lens implantation. 

. 2009 Jun;35(6):992-7. doi: 10.1016/j.jcrs.2009.01.031.

6. Al-Shymali O, Alió Del Barrio JL, McAlinden C, Canto M, Primavera L, Alio JL. Multifocal intraocular lens exchange to monofocal for the management of neuroadaptation failure. 

. 2022 Nov 1;9(1):40. doi: 10.1186/s40662-022-00311-4.

. Schallhorn SC, Hettinger KA, Teenan D, Venter JA, Hannan SJ, Schallhorn JM. Predictors of patient satisfaction after refractive lens exchange with an extended depth of focus IOL. 

. 2020 Mar 1;36(3):175-184. doi: 10.3928/1081597X-20200211-01. PMID: 32159822.

8. Botta J, Barsam A, Dmitriew A, Zaldivar R, Wiley WF, Windsor S. Factors influencing outcome satisfaction after cataract surgery: patient-reported insights from the RayPro database. 

. 2024;24(1):528. Published 2024 Dec 18. doi:10.1186/s12886-024-03800-3

9. Asena L, Kırcı Dogan İ, Oto S, Dursun Altınors D. Comparison of visual performance and quality of life with a new nondiffractive EDOF intraocular lens and a trifocal intraocular lens. 

 2023 May 1;49(5):504-511. doi: 10.1097/j.jcrs.0000000000001142.

10. Moshirfar M, Martin DJ, Jensen JL, Payne CJ. Light adjustable intraocular lenses: an updated platform for cataract surgery.

2023 Jan 1;34(1):78-83. doi: 10.1097/ICU.0000000000000911.

11. Madrid-Costa D, Cerviño A, Ferrer-Blasco T, García-Lázaro S, Montés-Micó R. Visual and optical performance with hybrid multifocal intraocular lenses. 

. 2010 Nov;93(6):426-40. doi: 10.1111/j.1444-0938.2010.00518.x.

. García-Bella J, Burgos-Blasco B, Vidal-Villegas B, Garzón N, Villanueva C, García-Feijoo J. Visual and refractive outcomes after bilateral implantation of an enhanced monofocal intraocular lens: prospective study. 

. 2024 Jun 1;50(6):585-590. doi: 10.1097/j.jcrs.0000000000001422.

. Zeilinger J, Kronschläger M, Schlatter A, et al. Comparing an advanced monofocal with a non-diffractive extended depth of focus intraocular lens using a mini-monovision approach. 

. 2024 Oct 28;271:86-95. doi: 10.1016/j.ajo.2024.10.014. Epub ahead of print. PMID: 39490721.

. Where are we going with IOL technology: a review of new and potential options for cataract surgery. 

 October 2022. Accessed January 17, 2025. https://modernod.com/articles/2022-oct/where-are-we-going-with-iol-technology

15. Kretz FT, Breyer D, Klabe K, et al. Clinical Outcomes After Implantation of a Trifocal Toric Intraocular Lens.

2015 Aug;31(8):504-10. doi: 10.3928/1081597X-20150622-01. PMID: 26274516.

16. Rayner. Pre-clinical and global evaluation. Presented at: European Society of Cataract and Refractive Surgeons 42nd Congress; September 6-10, 2024; Barcelona, Spain.

Mr Mantry is a consultant ophthalmologist with interest in cornea, cataract and refractive surgery. He is the founder and managing director at Vision Scotland.

Ms Mahmood is a refractive optometrist at Vision Scotland and is also an academic optometrist based at Glasgow Caledonian University.

Mr Neil Barnes, BSc(hons) MCOptom DipTp(IP)

Advancements in lens technology reflect the growing popularity of multifocal lenses

Grace Koennecke

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