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Heidelberg Engineering: Enhancing the Patient Journey

Clinical

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Authors

SS-OCT provides a clear view of the eye’s internal structures and any abnormalities, helping to differentiate benign from malignant lesions. 

Using swept-source OCT and OCT angiography to image choroidal tumours 

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

Myopia has rapidly become one of the most pressing public health challenges of the 21st century. Once considered a benign refractive error easily corrected with glasses or contact lenses, it is now recognised as a progressive, potentially sight-threatening disease. In developing countries, myopia is a leading cause of preventable blindness.

 Beyond impairing distance vision, myopia significantly increases the risk of severe ocular comorbidities and contributes to a growing global socioeconomic burden. With prevalence rates rising rapidly among children and adolescents, particularly in urbanised and developed regions, projections estimate that by 2050, nearly half of the world’s population will be myopic.

The global prevalence of myopia has surged from 22.9% in 2000 to an estimated 34% in 2020 and is expected to reach 50% by 2050, affecting nearly 5 billion people.

 High myopia (≤ −6.00 D), which carries a heightened risk of pathological complications, is projected to afflict almost 10% of the global population by 2050.

Recent meta-analyses indicate that among children and adolescents, the prevalence of myopia increased from 24.3% in 1990 to 35.8% in 2023 and is forecasted to exceed 39% by 2050.

 The highest rates of myopia are currently seen in individuals residing in East Asia and urban areas.

The progression of myopia is associated with irreversible vision-threatening conditions, which include the following:

: The leading cause of blindness in myopic individuals, characterised by progressive retinal atrophy and significant loss in best corrected vision.

Even children are affected: in a study of 274 children and adolescents (ages 7-17) with high myopia (≤ –6.00 D), 12.2% developed myopic maculopathy over 4 years.

: Myopic eyes are structurally elongated, predisposing them to retinal holes, lattice degeneration, vitreoretinal traction and detachment.

: Structural changes in highly myopic eyes increase susceptibility to these conditions.

 The risk of glaucoma increases by about 20% for every 1-D increase in myopia, with a disproportionately greater risk observed in individuals with high myopia.

Recent analyses have shown that there is no “safe” level of myopia.

 Even low-to-moderate myopia significantly increases lifetime risk. Each additional diopter of myopia increases the risk of myopic maculopathy by 67%, while slowing progression by just 1 D could reduce the risk by 40%.

 This relationship holds across all degrees of myopia, emphasising that even seemingly mild cases carry substantial lifelong risk.

While genetic predisposition plays a significant role in myopia development, particularly among children with one or two myopic parents, the recent, dramatic global surge in prevalence cannot be attributed to genetics alone. The rate of increase is too rapid to be explained by hereditary shifts, implicating environmental factors as the primary drivers of this epidemic. Large-scale studies confirm that while heritability contributes substantially to risk, environmental exposures, such as near work and reduced outdoor time, are critical modulators of myopia onset and progression.

Urbanisation has emerged as a major contributor, with children living in urban areas consistently demonstrating higher myopia rates than those residing in rural environments. This disparity is likely due to differences in lifestyle, including less time spent outdoors and greater engagement in near tasks such as reading and screen use.

 Reduced time outdoors is a well-established risk factor for myopia progression in children and adolescents.

Exposure to natural light is believed to stimulate retinal dopamine release, a key factor in inhibiting axial elongation, thereby offering a protective effect against myopia.

Conversely, increased near work and screen time have been associated with higher risks of both myopia onset and progression.

The COVID-19 pandemic exacerbated these environmental risks by shifting children’s activities indoors and dramatically increasing screen-based learning and entertainment. Studies during lockdowns revealed a marked rise in myopia incidence, especially among children aged 6 to 8 years.

 One large-scale Chinese study reported a mean myopic shift of up to –0.30 D within just a few months of confinement—an acceleration unprecedented in previous years.

Early-onset myopia, particularly before the age of 10, is strongly associated with faster rates of progression and a markedly increased lifetime risk of developing high myopia and its associated sight-threatening complications.

Younger children experience more rapid axial elongation and faster spherical equivalent changes than those with later onset, making early identification and timely intervention critical to mitigate future risks. Evidence indicates that children with earlier myopia onset not only have faster annual progression rates—often exceeding −0.75 D/y—but are also more likely to experience sustained, rapid progression over subsequent years if left untreated.

The global economic burden of myopia is substantial. In 2015, the potential productivity loss from uncorrected myopia was estimated at €216 billion ($244 billion), with an additional €5.32 billion ($6 billion) attributable to myopic macular degeneration.

Direct costs include refractive correction, clinical management and surgical interventions. Indirect costs include reduced work productivity, school performance and diminished quality of life.

Importantly, individuals with myopia experience significantly lower vision-related quality of life (QOL) than those with emmetropia, even after optical correction. Myopia adversely affects both visual functioning and socioemotional well-being, with even very low degrees of myopia associated with substantial declines in QOL.

 Studies have shown that high myopia impairs QOL to an extent comparable to keratoconus, an ocular condition traditionally associated with significant disability.

 Factors such as dependency on optical correction, limitations in recreational activities, reduced self-esteem and financial burden related to care contribute to this diminished QOL.

The rise in myopia is not only a crisis of visual acuity but also a looming epidemic of vision impairment and blindness. It is imperative that clinicians, educators, policymakers, and parents act collaboratively to implement evidence-based strategies to address this growing burden.

By focusing efforts on delaying the onset and slowing the progression of myopia, particularly during childhood, there is potential to significantly reduce future ocular morbidity and socioeconomic costs. Immediate action is essential to protect the visual health and QOL of future generations.

Ostrow is the director of paediatric ophthalmology at Scripps Clinic and the founder of Sydnexis, a biotechnology company focused on paediatric myopia. He holds multiple patents related to paediatric myopia and ophthalmic formulations, and he regularly lectures and presents on myopia management at national and international conferences. Dr Ostrow also serves as head of corporate relations for the American Association for Pediatric Ophthalmology and Strabismus, where he supports industry collaboration and advances in paediatric ophthalmology.

Kirkeby is a certified orthoptist and clinical researcher at Scripps Clinic in San Diego. She has published and presented extensively in ophthalmology and currently serves as a consultant for Sydnexis on their phase 3 clinical trial evaluating low-dose atropine for myopia.

Kirkeby has held executive leadership roles in orthoptic organisations across the US and Canada.

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The global prevalence of myopia has surged, and is expected to affect nearly 5 billion people by 2050

Myopia’s global impact,  by the numbers

Rajesh Deshmukh, MBBS, FRCS, and colleagues from Moorfields Eye Hospital, London, reported that resident ophthalmologists and consultant ophthalmologists had similar outcomes when performing immediate sequential bilateral cataract surgeries (ISBCS).

The COVID-19 pandemic was an important factor in the increasing popularity of ISBCS. Before the pandemic, the investigators explained, “ISBCS were reserved for complex health needs, paediatric patients, or patients with health anxieties undergoing general anaesthesia. More recently, ISBCS has gained popularity since the COVID-19 pandemic restrictions resulted in a backlog of unoperated cataracts worldwide.”

The advantages of performing a patient’s cataracts surgeries simultaneously are faster visual rehabilitation, improved vision-related quality of life, and higher productivity.

 When ISBCS were performed during the pandemic, the risk of spreading the virus was reduced by lower hospital attendance.

The reasons that many surgeons adhered to the standard practice of performing one cataract surgery at a time were concerns about bilateral complications, the inability to adjust intraocular lens power in the second eye, and the lack of established protocols for transitioning to ISBCS,

 Dr. Deshmukh and colleagues explained. The International Society of Bilateral Cataract Surgeons has recently noted an increasing ISBCS acceptance in well-selected cases.

The rationale for the study under discussion is that the experience level of the operating surgeon is a potential factor affecting the outcomes of all ophthalmic procedures, including ISBCS. “Previous studies have shown promising results for ISBCS performed by consultants and senior residents, but these studies had relatively small sample sizes.”

 Given the limited evidence on the impact of surgical experience on ISBCS outcomes, this study provided an opportunity to compare the outcomes of ISBCS performed over 3 years by resident ophthalmologists and consultant ophthalmologists to gain a more comprehensive understanding of the relationship between the grade of surgeon and ISBCS outcomes, they explained.

In all of the cataract surgeries, phacoemulsification and intraocular lens implantation were performed. The study outcomes were complications, refraction (spherical equivalent (SE) > 0.5 diopter [D] and >1.0 D from the predicted target refraction), and the uncorrected distance visual acuity (UDVA) logarithm of the minimum angle of resolution [logMAR]) at 3 months postoperatively. Resident ophthalmologists operated on 553 eyes and consultant ophthalmologists 687 eyes.

The investigators reported that the postoperative UDVAs were similar in both groups (

 = 0.26). The intra- and postoperative complications also were comparable between the groups (risk ratio, 1.88; 95% confidence interval, 0.8; 4.2) (

A new study compared results to determine a more comprehensive understanding of the relationship between the grade of surgeon and ISBCS outcomes

Dr J. Fernando Arevalo

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