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Prof Hogg presented a wide breadth of research at the International SPECTRALIS Symposium

Ruth Hogg, PhD, says NICOLA data emphasise the value of multicolor images

The European Commission provided a positive opinion from the European Medicines Agency (EMA) Committee for Advanced Therapies, providing an Advanced Therapy Medicinal Product (ATMP) classification to OCU400 (Ocugen, Inc.). OCU400 is the first gene therapy from the biotechnology company to move forward into Phase 3 with a broad retinitis pigmentosa (RP) indication.

ATMP classification is given to medicines that allow for innovative opportunities for the treatment of disease, thus accelerating the regulatory review timeline of the new gene therapy. The classification will also allow for further collaboration between Ocugen and the EMA, with the EMA in place for scientific advice and protocol assistance as the company pushes for Marketing Authorisation Application (MAA) filing in 2026.

“Receiving ATMP classification is another significant milestone toward bringing OCU400 to the market in Europe,” said Shankar Musunuri, chairman, CEO and co-founder of Ocugen. “This designation makes it possible to stay on track with our clinical and commercial strategy and potentially provide this novel modifier gene therapy candidate to all RP patients in the United States and Europe by 2027.”

Besides the EMA, the FDA has also acknowledged that the Phase 3 trial of OCU400 can suffice for Biologics License Application (BLA) and MAA submissions. Ocugen, Inc. plans to file simultaneously in the US and Europe after completion of the trial.

Currently, the Phase 3 OCU400 trial is undergoing enrollment, and the study has a sample size of 150 participants. Patients 8 years old and older with early through late-stage advancement of RP are being recruited to take part in the study.

“We are encouraged by the EMA’s recognition of OCU400 as the Phase 3 liMeliGhT clinical trial advances,” Huma Qamar, chief medical officer at Ocugen, said. “I look forward to working collaboratively with the EMA to address the unmet medical need that remains for nearly 98% of the RP patient population.”

Ocugen Announces Positive Opinion of European Medicines Agency’s Committee for Advance Therapies for Advanced Therapy Medicinal Product Classification for Modifier Gene Therapy Candidate OCU400 for Retinitis Pigmentosa. News release. Ocugen. Published February 3, 2025. Accessed February 3, 2025. https://www.globenewswire.com/news-release/2025/02/03/3019337/0/en/Ocugen-Announces-Positive-Opinion-of-European-Medicines-Agency-s-Committee-for-Advanced-Therapies-for-Advanced-Therapy-Medicinal-Product-Classification-for-Modifier-Gene-Therapy-Ca.html

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 OCU400

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

Much of the clinical conference circuit is characterised by innovation. New pharmaceutical developments, technological innovations and advanced techniques are frequent topics on congress podiums. However, the fundamental skills of ocular surgery are worth keeping in focus. That precept is proven in high-conflict areas, such as urban centres of war. 

Across the globe, some of the world's most skilled surgeons do not have the luxury to innovate or explore new avenues of eyecare. Instead, they are forced to operate without adequate supplies, with makeshift tools and sometimes even without electricity. This burden takes on more weight due to the high prevalence of ocular damage among patients who are the victim of blast injuries.

Oksana Vitovska, MD, is head of the ophthalmology department at the Bogomolets National Medical University in Kyiv, Ukraine. At the 

 in New Delhi, India, Prof Vitovska co-moderated a symposium which focused on ocular trauma care in combat zones. Here, she shares key takeaways from her own experiences and from her colleagues. 

Prof Vitovska demonstrates the importance of fundamental skills for every clinician—not just those operating in high-conflict areas—and illuminates actions the ophthalmic community can take to support their at-risk colleagues.

 Can you provide a brief overview of the cases presented during the “Eye surgery necessitated by war injuries” symposium?

Figure

 During the symposium, we heard from ophthalmic surgeons who worked both in first-line hospitals and in hospitals far from the conflict zone. As a rule, in a conflict zone, the main focus is on saving the life of a defender and providing primary care. Doctors shared their experience of managing combat eye traumas and presented a range of cases of severe ocular injuries, including open wounds, intraocular foreign bodies, chemical burns and complex orbital fractures. 

Many cases involved shrapnel wounds or blast injuries, both of which are rarely seen in civilian settings but are tragically common in war zones. The speakers gave us an insight into emergency and reconstructive procedures, highlighting the ingenuity and resilience required when standard resources are not available 

: How do the surgical interventions used here differ from those that could be used in traditional healthcare settings?

: Providing ophthalmic care in a combat environment is significantly different from a typical one. First of all, these are patients with various polytraumas; not only the eyes are affected, but also the nervous system, internal organs and limbs. Therefore, patients are sorted according to their life-threatening conditions. As a result, ophthalmological care is often delayed.

Another difference is the difficulty of evacuating soldiers and casualties under active shelling and drone attacks. The next is the limited resources. In conflict settings, there is often no access to general anaesthesia, electrocautery or even a stable power supply for microscopes or imaging tools. Surgeons have to adapt to unstable or makeshift surgical environments, visualisation may be limited and instruments may be improvised.

Of course, the severity of the lesions is also a difference. Most injuries are of a high degree of severity. Every third patient suffering from mine injuries is blind in one eye. Despite these limitations, the commitment to saving sight, and lives, remains unchanged.

: How can clinicians make quick decisions about interventions for eye trauma?

:Rapid triage is essential. After identifying life-threatening conditions, clinicians should prioritise based on the “three P's.” Those are: 

 for visual recovery. Open injuries, active bleeding and chemical burns require immediate attention. Even in resource-limited settings, a basic light perception test and pupillary reflexes can help guide decision-making. The key is to know which injuries are salvageable and which need to be stabilised for further referral. Clinical intuition based on trauma experience is invaluable when time and tools are limited.

The beginning of the war exposed gaps in the preparedness of civilian and military medical systems to deal with such complex ophthalmic injuries. Ukrainian ophthalmologists face challenges such as a lack of specialised equipment, limited access to high-resolution imaging (e.g., optical coherence tomography, orbital CT scans), difficulties in organising rapid and safe patient transport and the need to make urgent surgical decisions in austere conditions. But after almost 3.5 years of full invasive aggression, ophthalmologists accumulated great experience. At the same time, it should be reminded that daily attacks on medical facilities, hospitals and energy infrastructure lead to a continuous decrease in access to highly qualified eye care in the frontline areas.

Staged interventions allow for life- and vision-saving treatment while minimising risk of complications. Initial surgery might focus on wound closure and infection prevention. Secondary procedures like vitrectomy or lens implantation occurr later, when inflammation is controlled and proper tools or specialists become available. This phased approach reduces stress on ocular tissue and gives patients a better prognosis, even if initial visual outcomes are modest. Most cases are challenging as the practicing surgeons need anterior and posterior globe surgery skills.

: Which fundamental skills are particularly important in a resource-limited environment?

: In combat environments and resource-limited areas, clinical acumen becomes more important than advanced diagnostics.

Basic visual acuity assessment, even with improvised charts

Accurate wound assessment and foreign body detection

Manual suturing and globe repair techniques under local anaesthesia

These skills can be practiced regularly in civilian trauma centres or even through simulation workshops. In fact, we strongly advocate for hands-on trauma training as part of general ophthalmology education.

: What are the most-needed resources in combat areas?

: We urgently need both material and human support. On the technological side: portable slit lamps, battery-powered microscopes, headlamps and basic surgical packs are essential. We always need tactical glasses, which save eyes and vision. On the human side, there’s a dire need for retina and cornea specialists, oculoplastic surgeons and general ophthalmologists trained in trauma care. We would like to thank all our international colleagues, who, despite the threats, come to Ukraine, help our doctors in complicated surgery cases, teach them and share their experience gained in other military conflicts.

A call to action: We encourage clinicians globally to support mission-based outreach—either through short-term fieldwork or by offering remote guidance and mentorship. Training programmes for local surgeons, especially in countries like Ukraine, are crucial for building sustainable eye care in the face of ongoing conflict. The problem of ocular trauma, in the context of war, is not only a medical and clinical issue. It is a profound human, social and scientific challenge.

The development of comprehensive solutions for prevention, early diagnosis, effective treatment and long-term rehabilitation is essential both during wartime and for post-war recovery. The experience gained under such extreme conditions must be carefully studied and disseminated, contributing to international knowledge in ophthalmology, military medicine and trauma care

: Few clinicians find themselves in high-conflict settings. What do you wish more clinicians globally knew about this high-risk, urgent work?

: That it is both deeply humbling and profoundly human. The resilience of patients and the dedication of clinicians working under fire are astonishing. It’s easy to take sterile operating rooms and support teams for granted, until you witness someone suturing a globe injury by flashlight. Basic skills and simple tools can save a person’s sight, their livelihood or even their dignity. Global solidarity in ophthalmology is not just aspirational—it’s essential.

One final point we’d like to emphasise is the long-term burden of ocular trauma. Vision loss from war injuries doesn’t just affect individuals—it impacts families, communities, and entire healthcare systems. Rehabilitation, psychological support, and access to visual aids must be part of the care continuum. And importantly, we must work toward not just emergency response, but post-conflict rebuilding: training local experts, establishing referral networks and making sure no one is left behind.

I would like to express my deep gratitude to Sibylle Scholtz, PhD, for her initiative in organising the symposium, for her constant support and coverage of the state of Ukrainian ophthalmology during the brutal war of Russia against Ukraine. Dr Scholtz also provided support in the development and composition of this article.

I am grateful to the organising committee of the PAN Ophthalmologica Congress and Dr Arun Sethi for supporting this idea and highlighting our topical issue in the programme of the event.

The full symposia is available to view here.

Oksana Vitovska, MD | E: vo.visiondep@gmail.com

Vitoskova leads the ophthalmology department at the Bogomolets National Medical University in Kyiv, Ukraine, and is head of the Ukrainian Alliance of Ophthalmologists.

Scholtz is a subject matter expert of biometry and IOL power calculation. She is an asociated senior research fellow at the Institute of Experimental Ophthalmology, Saarland University, Homburg/Saar, Germany.

Every day brings a new challenge for surgeons in low-resource areas and conflict zones

Clinicians keep their eyes on wartime ocular trauma

I began implanting multifocal IOLs in 2016 for patients wanting to achieve presbyopic correction after cataract surgery, and I have used lenses from different manufacturers. However, an IOL from the AT LISA

 tri family (Carl Zeiss Meditec AG; Jena, Germany) is my preferred choice for the majority of eligible patients.

In my experience, the ZEISS AT LISA tri family is associated with faster visual recovery compared to other presbyopia-correcting IOLs. In addition, I find that patients implanted with an AT LISA tri enjoy excellent quality of vision, an outcome that I attribute to the high-quality optics. For patients needing astigmatic correction, I appreciate that the AT LISA tri toric platform provides excellent rotational stability. Importantly, patients treated with the AT LISA tri family are very satisfied with their long-term outcomes leading to a significantly high rate of word-of-mouth referrals.

Having such a positive experience with the AT LISA tri from ZEISS, I became interested in the AT ELANA

 841P trifocal IOL when it was introduced as a new addition to the ZEISS hydrophobic IOL portfolio. Compared with the AT LISA tri, the AT ELANA 841P offers the potential for better performance at near and intermediate distances, which is important when working at a computer or using a smartphone. The AT ELANA 841P optic is based on the AT LISA tri 839MP but is modified to have increased light transmission efficiency and a higher allocation of light to enhance near-to-intermediate vision without compromising far vision.** The AT ELANA 841P features a C-loop design with glistening-free*** hydrophobic biomaterial and is implanted using a fully preloaded injector system.

After achieving very good clinical outcomes in my first AT ELANA patients, I decided to add defocus curve performance testing to the follow-up regimen.

I recently conducted a retrospective analysis of data from 34 patients who had bilateral cataract surgery and implantation of the AT ELANA 841P. All patients had low levels of preoperative corneal astigmatism (range, 0.00 to 0.66 D). In addition, pre-operative refractive errors ranged from extreme myopia (-20.25 D) to high hyperopia (+4.00 D).

The results confirmed my initial positive impressions about the clinical performance of this new trifocal lens. Visual acuity (VA) outcomes of 28 patients evaluated at 1 month showed excellent functional vision across tested distances (table 1). Binocular uncorrected VA was 0.1 logMAR (Snellen equivalent 20/25) or better in all patients at distance, in 96% of patients at intermediate (80 cm), and in 89% at near (40 cm). Results for 18 patients seen at 3 months showed binocular uncorrected VA was 0.0 logMAR (Snellen 20/20) or better in all patients at distance and was 0.1 logMAR or better at intermediate in 83% and at near in 94%.

Defocus curve performance at 3 months showed that the AT ELANA 841P provided a broad depth of focus and a benefit of binocular summation, especially between +1.5 D and -3.0 D. Mean VA remained above 0.2 logMAR from +1.25 D to almost -3.0 D in monocular testing and from about +1.5 D to over -3.25 D in binocular testing.

Cataract surgeons who implant multifocal IOLs appreciate that achieving quality vision requires addressing pre-existing astigmatism. I believe in using a toric IOL to correct any “significant” corneal astigmatism. My threshold for implanting a toric IOL is ~0.5 D of regular corneal astigmatism, and a 1.0 D or 1.5 D cylinder IOL accounts for the vast majority of my toric IOL cases. Not uncommonly, patients need astigmatic correction with a toric IOL in only one eye. Once the AT ELANA 841P became available, I began using it for these latter patients in what I call the ‘ELISA’ approach (ELANA + LISA tri toric) where I implant an ZEISS AT LISA tri toric 939 M/MP IOL in the eye needing astigmatic correction and the ZEISS AT ELANA 841P in the fellow eye.

Results available from seven patients so far show that the ‘ELISA‘ approach is safe, effective, and associated with high patient satisfaction. Mean corneal astigmatism in these patients was 0.43 D in the eyes implanted with the AT ELANA 841P and 0.86 D in eyes needing toric correction. At the 3-month follow-up, all patients achieved binocular uncorrected VA of 0.1 logMAR or better at distance, intermediate, and near. Visual acuity outcomes (table 2) were similar to the bilateral AT ELANA 841P group.

Defocus testing in the ‘ELISA’ group highlights again the benefit of binocular summation but also shows that the AT ELANA 841P provides better performance than the AT LISA tri in the near and intermediate range (defocus steps -1.5 D to +2.5 D).

Based on the excellent clinical outcomes in the ‘ELISA’ group, I was interested in better understanding patient-reported outcome measures and conducted the Catquest 9SF survey. It was completed by all seven patients at an average follow-up of 8.6 months (range 5.5 to 9 months). All patients indicated being very or fairly satisfied with their vision and noted having no difficulty at all when reading subtitles on digital screens. Six out of seven patients reported that their sight caused no difficulty in daily life. The seventh patient noted only “some difficulty”.

The results from my analyses show the benefit of binocular summation when using multifocal IOLs. They also strengthen my belief that the design features of the AT ELANA 841P make it the most advanced presbyopia-correcting IOL for suitably selected patients wanting to reduce spectacle dependence across a full range of vision. Looking ahead, I hope to corroborate my conclusion with findings from Catquest 9SF surveys completed by patients who had bilateral AT ELANA 841P implantation. The combination of very good clinical outcomes and high patient satisfaction establishes ‘ELISA’ in my practice as a new option to treat patients requiring a toric IOL in one eye only. Based on my experience so far, I am comfortable using this approach for presbyopic correction in patients who prioritize full range of vision but need unilateral astigmatic correction.

Borkenstein AF, Borkenstein EM. Long-term clinical results and scanning electron microscopic analysis of the aspheric, hydrophobic, acrylic intraocular lens CT LUCIA 611P(Y). Clin Ophthalmol. 2018;12:1219-1227.

Borkenstein AF, Borkenstein EM. Geometry of acrylic, hydrophobic IOLs and changes in haptic-capsular bag relationship according to compression and different well diameters: A Bench study using computed tomography. Ophthalmol Ther. 2022;11(2):711-727.

** Compared to AT LISA tri in photopic conditions in virtual implantations and optical bench tests.

*** Grade 1 (traces) or better for 85% of the patients up to and including 12 months according to Christiansen scale and based on internal clinical trial outcomes and on published clinical data.

Joong Hun Kim, MD is the Medical Director at Gangnam ID Eye Center, Seoul, South Korea, specializing in cataract and refractive surgery. He is a paid consultant to Carl Zeiss Meditec.

In this insightful analysis, Dr. Joong Hun Kim presents real-world clinical outcomes with bilateral implantation of ZEISS AT ELANA 841P. Dr. Kim recommends AT ELANA® 841P as an excellent option for patients undergoing cataract surgery as its fully trifocal optical design translates into a full range of vision. He also introduces the so-called ‘ELISA’ approach for patients requiring astigmatic correction in one eye only, combining AT ELANA 841P and ZEISS AT LISA tri toric 939MP.  Early objective and subjective clinical data from this novel approach reveal promising visual outcomes and high patient satisfaction

Evaluating the clinical performance of ZEISS AT ELANA and the new ’ELISA’* approach

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has approved idebenone (Raxone, Chiesi) for treatment of Leber hereditary optic neuropathy (LHON) in patients 12 years of age and older. According to NICE, idebenone has been approved in final draft guidance, with NICE expected to publish final guidance in September.

 The National Health Service (NHS) will make the treatment available within 3 months of that publication date.

LHON is an inherited disease, and typically it first presents as painless blurring of central vision (unilateral or bilateral). It is a rapidly vision-threatening condition; many patients, most of them children or young adults in their 20s and early 30s, progress to complete vision loss within months. According to NICE, young men and boys are more likely to be diagnosed with LHON and experience subsequent vision loss. Around 250 people in England could be eligible for the new treatment, NICE said.

Clinical evidence from long-term trials of idebenone demonstrate that it has a reparative or regenerative effect on cells in the retina and optic nerve. Re-engaging those cells can improve or restore vision, and reduce progressive vision loss from LHON, according to NICE. Idebenone, delivered via oral tablets, is the first licensed pharmaceutical product to address the causes of LHON.

Professor Patrick Yu-Wai-Man, NICE committee member and Professor of Ophthalmology at the University of Cambridge, commented on the approval. “LHON causes devastating visual loss, and it is a life-changing diagnosis for the affected individual and their family,” he said.

 “This new medicine will come as a great relief to the LHON community in this country bringing hope to those who have experienced significant visual loss from this mitochondrial genetic disorder.”

Helen Knight, Director of Medicines Evaluation at NICE, called LHON a "debilitating" condition that robs patients of independence.

 "The sudden change in sight can make daily activities such as reading, travelling and recognising faces very difficult or impossible," she said. ""The evidence shows this treatment could improve people's eyesight and help their quality of life by allowing them to live independently for longer."

 shared a press release with more information on the approval.

 “Although idebenone has been available for limited use in Scotland and Wales, this is the first time patients in England will have access to the therapy through the NHS, ending years of geographical inequality and potentially improving quality of life for those affected,” the group stated in its press release. The charity characterised the approval of idebenone as a "landmark breakthrough" for the broader mitochondrial disease landscape.

“While it isn’t a cure, this treatment offers real potential for patients to preserve or improve vision, giving the chance to regain independence, confidence and a better quality of life. And the fact that there is now a treatment available for mitochondrial disease brings hope for future drug development," said Katie Waller, a paediatric nurse and the head of patient programmes at the Lily Foundation.

 "The fact that there is now a treatment available for mitochondrial disease brings hope for future drug development.”

More information about idebenone access through the NHS will become available in the remaining months of 2025.

Hundreds with rare inherited eye disease to benefit after NICE recommends treatment. Press release. NICE. 

Published August 7, 2025. Accessed August 7, 2025. 

https://www.nice.org.uk/news/articles/hundreds-with-rare-inherited-eye-disease-to-benefit-after-nice-recommends-treatment

The Lily Foundation celebrates approval of first ever mitochondrial disease treatment by NICE. Press release. The Lily Foundation. Published August 7, 2025. Accessed August 7, 2025. https://www.thelilyfoundation.org.uk/news/first-ever-mitochondrial-disease-treatment-approved/

In a press release, the National Institute for Health and Care Excellence announced the first-ever approval for a mitochondrial disease treatment

Ruth Hogg, PhD

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