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Heidelberg Engineering: Enhancing the Patient Journey

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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

Heidelberg Engineering announced its 2025 International SPECTRALIS Symposium (ISS) will be held in Heidelberg, Germany, from 13 to 14 June. This year marks the 21st anniversary of the ISS, and the event will be the first ISS held in the newly-opened Heidelberg Congress Center, the company said in a press release.

The keynote presentation will be given by Warren Hoburg and Tyson Brunstetter, OD, PhD, astronauts at the US-based National Aeronautics and Space Administration.

Frank Holz, MD, FEBO, FARVO, professor and chair of the Department of Ophthalmology at University of Bonn, Germany, will serve as chair for the symposium. Over the course of 2 days, attendees will be able to hear from 35 different speakers, traveling to Heidelberg from across 12 countries.

“What began 21 years ago as a dedicated retinal imaging event has evolved into a comprehensive platform for innovation in ophthalmology,” Prof Holz said in the press release. “The opportunity to engage with such a distinguished group of experts and discuss emerging therapies in this setting is truly unparalleled.

 includes seven different sessions over the course of the symposium, with multiple lectures on each topic: oculomics, High-resolution optical coherence tomography (OCT), new technology, age-related macular degeneration and geographic atrophy, artificial intelligence, retina and distributed care. The keynote session on Friday, 13 June will be presented in conjunction with NASA and is titled "A journey into space." 

Researchers use Heidelberg's Spectralis OCT technology onboard the International Space Station to investigate the effects of microgravity environments on vision. NASA began using the technology in 2013, and in 2019, a second Spectralis device equipped with the OCT2 Module was installed on the space station.

 The collaborative research focuses in part on Space Flight Associated Neuro-Ocular Syndrome (SANS), a condition that which commonly causes unilateral and bilateral optic disc oedema in patients who have spent time in microgravity environments.

“Every day at NASA we learn something new about the impact of space travel on the human body, and ocular health in particular,"  said Hoburg ahead of the meeting. "I am honored to be on this stage with Dr Brunstetter and look forward to sharing our insights, learnings, and experiences with this year’s symposium attendees."

Along with live scientific sessions, attendees will be able to visit the exhibition hall or take a tour of the SkyLabs Tower, Heidelberg Engineering's company headquarters. 

The exhibition hall will feature a showcase of the SeeLuma digital microscope with intraoperative OCT. Following the conclusion of the scientific programme on Friday evening, Heidelberg Engineering will host a boat cruise dinner reception on the river Neckar.

The full scientific programme can be found 

International SPECTRALIS Symposium – AND BEYOND. Press release. Heidelberg Engineering. Published March 7, 2025. Accessed March 7, 2025.

NASA Astronauts Warren Hoburg and Tyson Brunstetter to Headline Heidelberg Engineering’s 2025 International SPECTRALIS Symposium. Press release. Heidelberg Engineering. Published May 22, 2025. Accessed May 22, 2025. 

International SPECTRALIS Symposium and Beyond: Our Best Program. Heidelberg Engineering Academy. Accessed March 7, 2025. 

https://www.academy.heidelbergengineering.com/hedata/e-learning/Totara/Dateien/ScientificProgram_ISS2025_Heidelberg.pdf

The event will include presentations on artificial intelligence, ocular imaging and surgical topics

Heidelberg Engineering announces two-day International SPECTRALIS Symposium

Sylentis recently announced topline results from the SYL1801_II phase 2a study investigating SYL1801 for the treatment of neovascular 

 SYL1801 is an investigational small interfering RNA (siRNA) therapy administered via eye drops, rather than intravitreal injection, to treat nAMD. Sylentis, based in Madrid, Spain, said the primary endpoint was reached and more than 71% of patients in the mid-dose level maintained visual acuity over the 6-week study period.

"With these data from this explorative study of SYL1801, we are encouraged to put efforts into the subsequent clinical research program with proper guidance from the patient outcomes in the concluded study,” said Andreas Segerros, CEO of Sylentis.

Three parallel dose level cohorts of SYL1801 were evaluated in a double-blind study. A total of 99 subjects with treatment-naïve eyes of nAMD were followed for 42 days. The primary endpoint was to evaluate the effect of SYL1801 on the chance from baseline to the end of treatment in best corrected visual acuity (BCVA) score, according to the company’s press release. Throughout the study’s duration, it was found that all dose-levels of SYL1801 maintained visual acuity similarly, with the middle concentration of 25mg/mh achieving a statistically significant improvement of visual acuity at 42 days.

The company presented these results in a poster titled “

Association for Research in Vision and Ophthalmology (ARVO)

 annual meeting held 4-8 May in Salt Lake City.

1. Sylentis, a PharmaMar Group company, announces the positive results of the Phase IIa dose-ranging study for SYL1801 in patients with Age-Related Macular Degeneration (AMD) – Sylentis. Sylentis.com. Published 2025. Accessed May 15, 2025. https://sylentis.com/sylentis-a-pharmamar-group-company-announces-the-positive-results-of-the-phase-iia-dose-ranging-study-for-syl1801-in-patients-with-age-related-macular-degeneration-amd/

Three dose level cohorts of the small interfering RNA therapeutic were evaluated in a double-blind study

Topline results from investigational nAMD drop SYL1801 (Sylentis)

Teprotumumab (Tepezza, Amgen) received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as the first therapy specifically licensed for the treatment of adult patients with moderate-to-severe thyroid eye disease (TED), announced Amgen.

“The marketing authorisation for teprotumumab as the first therapy specifically licensed for thyroid eye disease (TED) in the UK marks a step forward for the patient community,” said Dr Tony Patrikios, Executive Medical Director, Amgen UK & Ireland.

The marketing authorisation for teprotumumab is supported by multiple clinical studies – OPTIC phase 3 clinical trial, TED01RV phase 2 clinical study, HZNP-TEP-403 phase 4 clinical study, and the OPTIC-J phase 3 study.

OPTIC was a prospective, multi-centre randomized, doubled-blind, placebo-controlled phase 3 trial of the IGF-1R inhibitor teprotumumab or placebo in adults with Graves’ disease and active moderate-to-severe thyroid eye disease. It enrolled 83 patients between the ages of 18-80 years old and randomized 1:1 to receive 8 intravenous infusions of either teprotumumab or placebo.

The study demonstrated teprotumumab significantly improved the primary endpoint, proptosis (eye bulging) responder rate. The study showed that at 24 weeks, 83% of participants demonstrated a reduction of at least 2mm compared to baseline, compared to 10% of patients treated with placebo.

“TED can negatively affect patients’ lives impacting vision, causing eye pain, making everyday tasks difficult and causing a loss of self-confidence,” Dr Patrikios said. “This authorisation introduces a new alternative treatment option and reinforces Amgen’s commitment to supporting eligible patients with serious, underserved conditions.”

This progressive and potentially vision-threatening condition, approximately 50,000 people are living with TED in the UK. TED can cause eye bulging, double vision, eye pain, redness, and swelling.

“For adult patients living with thyroid eye disease, it can be challenging to receive a diagnosis and referral to specialist centers,” said Dr Jimmy Uddin, Consultant Ophthalmologist, Oculoplastic & Orbital Surgeon, Moorfields Eye Hospital and St George’s Hospital Medical School. “Teprotumumab offers eligible TED patients in the UK an important new treatment option.”

1. Amgen’s TEPEZZA (teprotumumab) Granted Marketing Authorisation as the First Targeted Treatment Specifically for Adults With Moderate-to-severe Thyroid Eye Disease (TED) in the United Kingdom. BioSpace. Published May 8, 2025. Accessed May 8, 2025. https://www.biospace.com/press-releases/amgens-tepezza-teprotumumab-granted-marketing-authorisation-as-the-first-targeted-treatment-specifically-for-adults-with-moderate-to-severe-thyroid-eye-disease-ted-in-the-united-kingdom

Teprotumumab is the first therapy specifically licensed for the treatment of moderate-to-severe thyroid eye disease in the UK

Sponsored by Biogen

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