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A retrospective analysis illuminates discrepancies between adult and paediatric cataract procedures around the globe

The true costs of treating paediatric cataracts

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

 is proud to report that MJH Life Sciences® has announced its acquisition of the EnVision Summit, a premier certified continuing medical education (CME) ophthalmology conference. The EnVision Summit, held annually in Puerto Rico, combines an innovative CME-certified education programme with a first-class family experience.

The summit will be hosted as a CME-certified conference within the Physicians’ Education Resource® legacy portfolio, supported by the eye care network brands 

. MJH Life Sciences noted in a press release that the acquisition aligns with its long-term growth strategy supported by a strategic partnership with BDT & MSD Partners.

The holistic approach to the summit includes age-appropriate activities for participants' family members, including children. In 2024, the EnVision Summit debuted an optometry track concurrent with the existing ophthalmology sessions.

Bonnie An Henderson, MD, the EnVision Summit director and cofounder, expressed enthusiasm about the future of the summit under MJH Life Sciences’ leadership. Dr Henderson President and CEO of global nonprofit HelpMeSee, as well as a past president of the American Society of Cataract and Refractive Surgery. 

“I am thrilled about the possibilities that this acquisition brings for the EnVision Summit,” Dr Henderson said. “With the resources and expertise of MJH Life Sciences, we will be able to elevate our educational offerings to new heights, ensuring that eye care professionals worldwide have access to the most current and comprehensive information in multiple channels to better serve their patients. I look forward to continuing as the Programme Director to maintain the excellence of the content and faculty.”

Mike Hennessy Jr., president and CEO of MJH Life Sciences, commented on the news, describing it as a continuation of MJH Life Sciences’ mission. “As we continue to expand our commitment to education in the eye care space, the acquisition of EnVision Summit allows us to build on the strong foundation we’ve established with our leading brands,” he said. “The summit and its hundreds of loyal attendees will benefit not only from our expertise in providing engaging educational experiences on cutting-edge topics, but also from new and expanded opportunities to help them address the rapidly evolving ophthalmic landscape.”

The upcoming EnVision Summit is scheduled for 

To learn more and to register for the event, please visit 

MJH Life Sciences® acquires EnVision Summit, expands leadership in eye care education. MJH Life Sciences. Press release. Accessed 9 October, 2024.

The Eye Care Network adds a longstanding, CME-certified conference to its live event programming

Ophthalmology Times Europe parent company MJH Life Sciences® acquires eye care conference EnVision Summit

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. Hackle 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, ANTERIONⓇ 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. 

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 inpremium 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 ofretinal 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.

Enhancing the Patient Journey Solutions for Streamlining Surgical Success

Glaucoma specialists worldwide face numerous challenges daily, from early detection to accurate diagnosis and ongoing patient management. The Heidelberg Engineering Glaucoma Workflow Solution is designed to provide the tools you need to deliver the best care to your patients. It offers dynamic visualization of parameters, efficient data management, precise imaging, and robust monitoring capabilities. Find out how glaucoma experts around the world are leveraging these advanced technologies to enhance the patient journey, increase diagnostic confidence, streamline workflows, and improve patient outcomes.

“It was a surprise as I didn’t feel my vision had been hindered in any way. At that point, I didn’t know that glaucoma was rampant in my family on both my mother’s and father’s sides. When I shared the news of my glaucoma with my late mother, she did not miss a beat, replying, ‘Oh honey, your father and I have had glaucoma for years’. To which I could only say, ‘Really Mom, maybe you and Dad could’ve mentioned that […] like 20 years earlier.” PHILLIP VAN LEAR, diagnosed at 48 

One of the most significant challenges in glaucoma management is detecting the disease early, as it often progresses without symptoms. “

Early glaucoma has no symptoms,” explains Christian Mardin, Consultant Ophthalmologist at Friedrich-Alexander-Universität, Erlangen, Germany. “Every person over 40 should go to their optometrist or ophthalmologist to get their optic nerve head checked

Continue reading Prof. Mardin’s insights on early glaucoma detection here.

The electronic medical record platform HEYEX EMR helps streamline this process by managing and presenting comprehensive ophthalmic patient records through an intuitive interface. It provides access to high-quality, structured data, aiding in efficient reporting and auditing. Dr. Hackle of Hanusch Hospital, Vienna, recalls how HEYEX EMR helped the hospital streamline their workflow and allowed access to patient records in over 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 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.

As early detection becomes more efficient, the next step is ensuring accurate diagnosis, where the 

The Glaucoma Module Premium Edition (GMPE)

 provides detailed imaging and analytics of the optic nerve head and retinal nerve fiber layer. Using the Anatomic Positioning System (APS) ensures an accurate anatomical setup for optimal comparison with the normative reference database. These tools equip you with the information needed to support confident diagnostic decisions. 

Download the SPECTRALIS Glaucoma Toolkit here.

 allows for non-contact assessment of iridocorneal angles and anterior segment anatomy, providing precise measurements and automatic identification of the scleral spur to enhance your early detection capabilities. 

Dr. Benjamin Xu, Chief of the University of Southern California's Glaucoma Service, presents a webinar on using non-invasive anterior segment imaging, including ANTERION® technology and AI, to detect and treat angle closure glaucoma. 

Once a confident diagnosis is achieved, effective management relies on seamless referrals and data sharing, which is where the integration of HEYEX EMR with the 

 platform becomes indispensable. Effective glaucoma management necessitates streamlined referrals and data sharing throughout your clinic. This system centralizes patient information, minimizing duplication and manual data entry errors.

HEYEX 2 Cloud Exchange facilitates secure, peer-to-peer transfer of images and data over the internet, eliminating the need for VPN connections. This feature enables efficient and encrypted data transfers, ensuring timely communication with other healthcare providers and enhancing your referral process. Learn to start using Cloud Exchange and transfer data after setting it up on 

 enhances your diagnostic workflows by enabling side-by-side review of images and reports from both eyes, consolidating all pertinent data for comprehensive analysis, in one single view.

“I have chanced upon signs which masquerade as glaucoma on an OCT scan. Branch retinal artery occlusions or cotton wool spots — small infarcts or blood vessel closures — can result in an initial swelling in the nerve fibre layer. They are transient and disappear in a few weeks, and are often caused by high blood pressure or kidney disease.” 

PROF. SANJAY ASRANI, Duke Eye Center, North Carolina, USA 

Accurate glaucoma diagnosis hinges on comprehensive examination techniques. The SPECTRALIS GMPE provides accurate measurements and visualization of key parameters involved in glaucoma diagnosis such as the optic nerve head, retinal nerve fibre layer, and macular ganglion cell layer, via OCT imaging. Tools like Bruch’s Membrane Opening – Minimum Rim Width (BMO-MRW) offer objective, geometrically accurate measurements of the neuro-retinal rim, aiding your early detection efforts. The reference database further guides your analyses.

Learn to integrate the power of OCT imaging and SPECTRALIS GMPE in your daily practice in this educational webinar by Dr. Swarup Swaminathan. 

Sometimes glaucoma needs to be differentiated from other conditions with similar presentations. Recognizing these nuances ensures your accurate diagnosis and effective treatment planning.

Regular monitoring is critical for managing glaucoma patients. The HEYEX 2 Multimodality Viewer supports ongoing data sharing and displays follow-up examinations across multiple locations, allowing you to access previous images and reports easily. Post-surgery, the ANTERION Metrics App provides precise measurements and visualizations of the anterior chamber and the anterior chamber angle, crucial for effective patient management.

Integration with the SPECTRALIS core technologies, such as TruTrack Active Eye Tracking and AutoRescan, ensures accurate monitoring of disease progression. These tools enable follow-up scans in the exact anatomical locations as previous exams, allowing you to detect minute changes with high precision.

, the world's first fully digital microscope, offers unparalleled precision through its 3D visualization technology. It provides exceptional image quality, ergonomics, and educational features, significantly benefiting your surgical practice.

The Heidelberg Engineering Glaucoma Workflow Solution is designed to integrate seamlessly into your patient care routine, supporting unparalleled diagnostic confidence and efficiency. By leveraging these advanced tools and technologies, you can overcome the challenges in glaucoma management, improving patient outcomes and engagement.

Delve deeper into how these solutions can transform your practice.

Enhancing the Patient Journey Solutions to Overcoming Challenges in Glaucoma Management

EURETINA 2024: Andrea Govetto, MD, PhD, speaks about macular oedema and the Ramin Tadayoni Award

On the opening day of the European Society of Retina Specialists (EURETINA) meeting, Andrea Govetto, MD, PhD, received the inaugural 

 booth to discuss his wonderful research team, the things we fail to understand about diabetic macular oedema and what makes EURETINA a must-see conference.

Editor's note: The below transcript has been lightly edited for clarity.

Hello. I'm Andrea Govetto. I'm a VR surgeon at the Humanitas University in Milan, and I'm here at EURETINA as a presenter in the faculty.

I'm honored to receive the [Ramin Tadayoni] award. The project is very cool, actually. It's a computational model of fluid flow in macular oedema.

So macular oedema is something that many people think is obvious, but is not, because we actually don't know why the cysts form where they are located and why they persist in some cases. So the engineers, because I don't know anything about mathematics—the award will go to pay the engineers to explain, to make a mathematical simulation and explain me why the cysts in macular oedema form, and why so specifically in the macula, which is a very particular part of the retina. My guess is that the morphology of the cell there plays a key role in the formation of the oedema.

You know, nobody likes to work for free, so it's important to reward the work of others. So, I work with a beautiful team. My chief is Mario Romano, who is also presenting here at EURETINA, and I work with two very talented engineers, which are Alessia Ruffini from Genoa and Rodolfo Repetto from Genoa. The bulk of work for the mathematics is on them. So, these funds will go, partially, to pay them for their great work. It's a way to reward what they are doing because until now, they’ve worked for free, basically.

So, specifically, epiretinal membranes and the laminar macular holes. Actually, tomorrow, we have a very great session, with, ESASO and FLORETINA on laminar macular holes. A lot of very good presenters will be there, me as well. So it will be fun and interesting to see.

And then I have a course, which we did also last year at EURETINA, purely focused on the epiretinal membrane, and I will speak, specifically, about the pathophysiology and the classification of an epiretinal membrane that we developed in these years. So I think it would be very interesting to attend.

The most interesting thing about this meeting is connections. I'm lucky, because I know many people around the globe, and many of them are coming here to Barcelona. So it's a way to see my friends that live abroad in South America, in Argentina, in the US, in Japan. So I like very much the connections that you can make here in EURETINA.

We spoke with Andrea Govetto, MD, PhD, winner of the inaugural Ramin Tadayoni Award at EURETINA

EURETINA 2024: Andrea Govetto, MD, PhD, says it takes teamwork to understand macular oedema

Johnson & Johnson Vision has announced that it supports the new European Commission survey that will impact whether or not the European Commission (EC) will allow the use of electronic Instructions for Use (eIFU) for all professional use devices, which are mainly utilised for implantable medical devices. This may impact ophthalmic devices, including contact lenses, according to a statement. The survey will be open for healthcare professionals to submit their feedback until 11 October, 2024.

“This new survey launched by the European Commission allows healthcare professionals to have a voice in any potential eIFU expansion and is a positive step towards a more sustainable healthcare industry in Europe. As a leading eye health company, J&J is fully committed to supporting any measures that can reduce waste, use less resources, and help practitioners and consumers to recycle more,” says Jacqueline Henderson, President EMEA, Johnson & Johnson Vision.

The EC’s survey follows suit of trade associations Medtech Europe and Euromcontact, who also conducted surveys gathering feedback from healthcare professionals and contact lens users. The results, which were shared with EC, were overwhelmingly positive, the statement said. The EC’s goal in conducting its own survey is to validate the findings from the previous surveys, which could shape future policy decision regarding the expansion of eIFU legislation.

The EC and EU Competent Authorities also reached an agreement in February 2024 to further evaluate the possibility of expanding the scope of products that are permitted to use eIFU. If the EC were to consider expansion of this scope, legislative changes would be necessary.

Those interested in filling out the EC’s survey can find it on the commission’s 

Depending on results from the survey for healthcare professionals, a scope expansion for eIFUs could impact ophthalmic devices including contact lenses.

By Hattie Hayes; Reviewed by by Vinita Rangroo Thrane, MD, PhD; Alexander S. Thrane, MD, PhD, FEBOphth; and Nils-Erik Boonstra, MD

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