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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

During the 2025 EURETINA congress, the Eye Care Network spoke with Mark Gillies, MD, PhD, director of research at the Save Sight Institute, about anti-VEGF agents.

During the 2025 congress of the European Society of Retina Specialists (EURETINA), the Eye Care Network spoke with Mark Gillies, MD, PhD. Prof Gillies is affiliated with the University of Sydney, where he is the director of research at the Save Sight Institute. He also leads the Fight Retinal Blindness! Registry, a global database of clinician-reported patient data.

Established in 2007, the registry tracks outcomes of anti-VEGF injections. Today, over 150 practitioners from 20 countries in Australia, Asia and Europe enter their patient data into the registry.

"The unique thing about our registries is we identified a minimum prospectively-identified outcome set that has to be tracked at every visit. If you try to finalise the data without entering all the in-range fields, then it won't accept it, and it tells you what you have to fill out. So, you get 100% quality data from every visit, for every patient, for the last 20 years. With this, we've been able to do many analyses," Prof Gillies said. "We've published about 100 publications over the last 15 years, and we distinguish ourselves from the other registries because they tend to scrape data. So the IRIS registry, for example, will just scrape electronic medical records, but they don't get complete data from every visit."

At the 2025 EURETINA meeting, Prof Gillies presented research findings on next-generation VEGF inhibitors, including Eylea HD and Vabysmo. "These things become stronger as you go," he noted. "So at the moment for Vabysmo, we have 2 years [of data], and for high dose Eylea it's just 1 year. But in 3 or 4 years, it will have really good amounts of data so that we can tell which drug is going to be best for which patient. We will also track the biosimilars as they come out. They haven't really been through such a thorough evaluation process, but we'll be tracking them just like the other drugs, and we'll see whether they really are as efficacious as they claim to be and as safe as they claim to be."

To learn about the research findings Prof Giliies presented at this year's EURETINA meeting, watch the full video.

Today, over 150 practitioners from 20 countries in Australia, Asia and Europe enter their patient data into the Fight Retinal Blindness! Registry

Mark Gillies, MD, PhD, introduces the next generation of anti-VEGF agents

Global artificial intelligence (AI) medical technology company Eyenuk has received the green light to deploy its EyeArt AI Eye Screening System in the South-Eastern Norway Regional Health Authority.

 With the goal of scaling the technology’s use across Norway’s National Health System in the coming years, this deployment is the first time that a national health system has broadly adopted autonomous AI technology for the detection of eye disease, according to a news release.

EyeArt is the first FDA-cleared AI technology for autonomous detection of more-than-mild and vision-threatening diabetic retinopathy (DR), according to a press release from Eyenuk.

"[EyeArt] helps us to examine more people with diabetes," said Ulrich Spreng, medical director at the South-Eastern Norway Regional Health Authority, in the release. "With better use of health care professionals' time, we expect that the waiting time for retinal examinations will be significantly reduced. A better patient overview will also provide more efficient management and control and create the foundation for greater equality in treatment."

The South-Eastern Norway Regional Health Authority is the largest of Norway’s four regional health systems. It covers 3.1 million people (over half of the country’s population), including in Oslo, Norway’s capital. The country has a goal of ensuring that more than 95% of patients with diabetes receive timely retinal examinations.

 A Menon Economics report stated that achieving over 95% of eye screening coverage for patients with diabetes could reduce Norway’s annual disease burden by about 250 million kr (around €21.3 million).

Currently, only 55% of patients receive these examinations in the country. The health authority also “aims to expand capacity, reduce bottlenecks, and provide timely, equitable access to diabetic eye screenings” through the deployment, the release stated.

The contracting and deployment of EyeArt is being facilitated by Human Bytes, a Nordic specialist in the implementation and scaling of AI for health care and a current distributor for EyeArt.

"Diabetic retinopathy is the most common complication of diabetes and the most common cause of vision loss and blindness in the working age [population]. The new AI solution will change the way we do retinal examinations," said Maja Gran Erke, MD, PhD, clinical project manager in the regional project Regular Retinal Examination for Diabetic Retinopathy, in the release.

 that assessed the implementation of DR screening in the Oslo region. The cross-sectional study of a cohort of adult patients with type 1 or 2 diabetes mellitus assessed 180 eyes of 90 patients. Study authors were led by Ellen Steffenssen Sauesund, MD, of the Department of Ophthalmology, Oslo University Hospital, and Center for Eye Research and Innovative Diagnostics, Department of Ophthalmology, Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway. The authors found that 62.8% of patients that were not newly diagnosed with diabetes mellitus (DM) had never had an eye examination, and duration of diabetes mellitus for those patients was up to 18 years (median: 8 years). Additionally, it was more than 2 years since the last eye examination for 68.8% of the patients who had previously received an eye examination.

“This study underscores the need for implementing a systematic DR screening program in the Oslo region, Norway, to better reach out to patients with DM and improve their screening adherence,” the study authors stated.

 “Timely and proper treatment can prevent or mitigate vision loss and improve the prognosis. A considerable number of patients were referred from general practitioners for not being followed by an ophthalmologist.”

Eyenuk secures world’s first national health system deployment of autonomous AI eye screening technology. News release. GlobeNewswire. September 17, 2025. Accessed September 17, 2025. 

https://www.globenewswire.com/news-release/2025/09/17/3151533/0/en/Eyenuk-Secures-World-s-First-National-Health-System-Deployment-of-Autonomous-AI-Eye-Screening-Technology.html

Menon Economics. VURDERING AV POTENSIALET FOR REDUKSJON AV SAMFUNNSKOSTNADER KNYTTET TIL ØYESYKDOM I NORGE MED TELEMEDISINSK AVSTANDSOPPFØLGING – EYECHECK SYSTEM. 2020. 

https://menon.no/uploads/images/2020-45-Eyecheck-System.pdf

Sauesund ES, Jørstad ØK, Brunborg C, et al. A pilot study of implementing diabetic retinopathy screening in the Oslo region, Norway: baseline results. 

 2023;11(4):1222. doi:10.3390/biomedicines11041222

EyeArt uses artificial intelligence for autonomous detection of vision-threatening diabetic retinopathy


Eyenuk deploys autonomous AI eye screening technology throughout Norway

Heidelberg Engineering, STAAR Surgical and Ziemer Ophthalmic Systems are among the latest companies to announce details of their presentations during the 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) being held 12-15 September in Copenhagen, Denmark.

Heidelberg Engineering announced the launch of the company’s newest ANTERION software update, with the introduction of the new Cataract App Key Measurements Export, that will be showcased during ESCRS 2025.

 This new software streamlines surgical workflow, offering cataract and refractive surgeons more efficient integration into their existing clinical workflow.

ANTERION uses optimised swept-source optical coherence tomography (OCT) technology, and through the the Cataract App, it offers a central place for key measurements for cataract surgery planning, including corneal analysis, anterior chamber depth, lens thickness and axial length.

 Using high-resolution OCT images spanning from the anterior surface of the cornea to the posterior surface of the lens, “the Cataract App provides a visual analysis of the whole anterior segment,” the Heidelberg Engineering website states.

New features of the Key Measurements Export offer the transfer of essential biometry data from the Cataract App in DICOM format, supporting interoperability with electronic medical records (EMRs), IOL calculation software and other DICOM-supported third-party applications.

 Additionally, the new software update automatically generates a Cataract Key Measurement Report PDF to store in the patient record within Heidelberg’s image management and device integration platform, 

The company will also be showcasing the upcoming 

STAAR Surgical has a full lineup for the annual meeting. The company is known for its Implantable Collamer Lens (ICL), which includes the EVO ICL product line, a cornea-preserving alternative for the correction of myopia and astigmatism.

Last month, Alcon entered into a definitive merger agreement with STAAR Surgical, through which Alcon intends to acquire STAAR.

The planned acquisition of STAAR includes the EVO family of lenses for vision correction for patients with moderate to high myopia with or without astigmatism. EVO ICLs are implantable lenses that address a wide range of vision correction needs through a minimally invasive procedure that is reversible.

celebrated 3 million global sales of the ECO ICL

 of its proprietary Implantable Collamer Lens in October 2023.

STAAR Surgical presentations during the 43

Correlation Analysis of Horizontal and Vertical Ciliary Sulcus Diameters Across Diverse Refractive Populations

Horizontal and Vertical Ciliary Sulcus Diameter Difference (CsDiff): A New Indicator for ICL Size Selection and Vault Prediction

The Long-Term Effects of Insufficient Vault After ICL Implantation in Patients with Low to Moderate Myopia

Mid-Term Intraocular Pressure (IOP) After Toric vs. Non-Toric ICL” Influence of Lens Power and Biometric Parameters

12-Month Clinical Outcomes of Implantable Collamer Lens for Myopic Regression After Laser Vision Correction

Long-Term Stability and Predictability of Phakic ICL Implantation in Low Myopia

Poster Pod 3, Balcony 2: Corneal Endothelial Cell Changes After Implantable Collamer Lens Implantation in Myopic Patients: A 3-Year Experience

Poster Pod 3, Balcony 2: Pilot Study of Sphere and Toric Phakic Implantable Collamer Lenses to Correct or Reduce Myopia with Presbyopia, With or Without Astigmatism

Foyer F6 & F7, Balcony 2: Comparison Between Vertical and Horizontal Implantable Collamer Lens (V4c) Implantation Positioning and Its Effect on Decentration and Visual Outcomes

Swiss-based tech company Ziemer Ophthalmic Systems will showcase its latest innovations during ESCRS 2025.

“With a clear commitment to advancing ophthalmic care, Ziemer continues to expand its comprehensive portfolio for modern anterior segment surgery—ranging from refractive and cataract solutions to corneal therapeutic procedures,” the company said in a press release.

—Designed to elevate the patient experience, CLEAR Supra is the next generation of personalized lenticule extraction, which sets new standards in precision and natural vision quality.

—This innovation allows for fully customized segments and tunnel procedures, combining all FEMTO-CAIRS features into a single, versatile laser platform.

—Powered by Ziemer’s proprietary wet ablation technology, AQUA LASIK introduces a new standard in LASIK surgery: no smell, no noise and no stress. The AQUARIUZ laser operates without gas and preserves corneal water content, redefining patient comfort.

—A seamlessly connected digital platform and diagnostic system that optimize clinical workflows and empower surgeons to deliver outstanding care at every step.

—A faster, smarter operating environment set to transform cataract surgery and redefine its future.

Heidelberg Engineering at ESCRS 2025: New ANTERION feature streamlines cataract workflow and fosters ecosystem integration. Published September 11, 2025. Accessed September 11, 2025. 

https://www.heidelbergengineering.com/int/press-releases/heidelberg-engineering-at-escrs-2025-new-anterion-feature-streamlines-cataract-workflow-and-fosters-ecosystem-integration/

Cataract App - Multi-modal imaging platform optimized for the anterior segment | Heidelberg Engineering. Heidelbergengineering.com. Published 2025. Accessed September 12, 2025. 

https://business-lounge.heidelbergengineering.com/us/en/products/anterion/cataract-app/

STAAR Surgical 2025 – Copenhagen Booth #C3.031. Published September 10, 2025. Accessed September 11, 2025.

Harp MD. Alcon agrees to acquire STAAR Surgical. Ophthalmology Times. Published August 5, 2025. Accessed September 12, 2025. 

https://www.ophthalmologytimes.com/view/alcon-agrees-to-acquire-staar-surgical

Ziemer Presents Groundbreaking Innovations at ESCRS 2025. Published September 12, 2025. Accessed September 12, 2025.

Leading companies spotlight innovations in cataract and refractive surgery at the 43rd ESCRS Congress in Copenhagen

Marina Roizenblatt, MD, PhD; Júlia Jiquilin Carvalho, MD; Lucas Zago Ribeiro, MD; and Mauricio Maia, MD, PhD

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