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Heidelberg Engineering: Enhancing the Patient Journey

Clinical

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A recently developed tool can help ophthalmologists to assess the quality of findings from real-world studies in retinal diseases. This will help them decide which results are most robust and applicable to their practice. 

Assessing the quality of real-world evidence in retinal diseases 

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

Evidence from a new study shows that cannabis use may exert a moderately protective effect against the development of proliferative vitreoretinopathy (PVR) after repair of retinal detachments (RDs),

 according to first author Ahmed M. Alshaikhsalama, MD, Department of Ophthalmology, UT Southwestern Medical Center, Dallas.

Investigators from the Department of Ophthalmology, Baylor College of Medicine, Houston, Texas; Horngren Family Vitreoretinal Center at Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California; and the Department of Ophthalmology, Palo Alto Medical Foundation, California, joined him in this study, whose results were published in 

PVR is the leading cause of rhegmatogenous retinal detachment (RRD) repair failure, affecting up to 10% of cases.

 Despite modern surgical advances in instrumentation and technique, PVR poses a major risk during the postoperative period,

 Alshaikhsalama and colleagues explained.

Risk factors for PVR include increased age, cigarette smoking, globe trauma, vitreous hemorrhage at the time of repair, and myopia.

 Recognition of these factors is particularly helpful in preoperative counseling. However, little is known about any potential impact of cannabis use.

 plant and its primary active compound, tetrahydrocannabinol (THC), have been used as a natural anti-inflammatory for centuries.

Cannabis reduces microglial activity, expression of inflammatory cytokines, and retinal neurotoxicity through action on adenosine and cannabinoid receptors in animal models.

However, cannabis has also been found to be a potential risk factor for exacerbating thyroid eye disease, dry eye syndrome, and neuroretinal dysfunction.

These contradictory effects led the investigators to evaluate the outcomes of patients who underwent primary RD repair and who used cannabis compared with matched control patients without a history of cannabis use.

The investigators examined data from electronic health records for a multicenter research network from February 1, 2005, to February 1, 2025. All participants had undergone an initial RD repair with pars plana vitrectomy with or without scleral buckle (SB), primary SB, or pneumatic retinopexy. The records were used to identify patients diagnosed with concomitant cannabis-related disorder, together with confirmatory testing of cannabis in urine or blood, compared with a control group without documented cannabis use, the authors recounted.

The main outcome measure was the relative risk (RR) of developing PVR and requiring subsequent complex RD repair at 6 months and 1 year of follow-up.

Each cohort had 1193 matched patients. The mean plus/minus standard deviation age was 53.2 (16.1) years; 1662 patients were male (69.7%), 641 were female (26.9%), and the sex was unknown for 83 patients (3.5%).

“At 6 months, patients with concomitant cannabis use with RD repaired by any method had a reduced risk of developing subsequent PVR (25 events [2.10%] vs 52 events [4.36%]; RR, 0.48; 95% confidence interval [CI], 0.30-0.77; 

 = .002) and requiring complex RD repair (37 [3.10%] vs 60 [5.03%]; RR, 0.62; 95% CI, 0.41-0.92; 

 = .02) compared with controls. Similar results were observed at 1 year for both outcomes,” the investigators reported.

“This is the first study to examine a potential relationship between long-term cannabis use and subsequent PVR. While cannabis use demonstrated a lower RR for PVR, the small absolute reduction (~2%) may not be clinically meaningful. Confounders may account for all the observed associations. Future prospective studies are required to further clarify and characterize the effect of long-term cannabis use on PVR development and management,” Alshaikhsalama and colleagues noted.

Alshaikhsalama AM, Alsoudi AF, Mukhtar A, et al. Long-term cannabis use and risk of postoperative proliferative vitreoretinopathy. 

 Published online July 3, 2025. doi:10.1001/jamaophthalmol.2025.1851

Girard P, Mimoun G, Karpouzas I, Montefiore G. Clinical risk factors for proliferative vitreoretinopathy after retinal detachment surgery. 

Ryan SJ. The pathophysiology of proliferative vitreoretinopathy in its management. 

Charteris DG, Sethi CS, Lewis GP, Fisher SK. Proliferative vitreoretinopathy– developments in adjunctive treatment and retinal pathology. 

Heimann H, Bartz-Schmidt KU, Bornfeld N, Weiss C, Hilgers RD, Foerster MH; Scleral Buckling versus Primary Vitrectomy in Rhegmatogenous Retinal Detachment Study Group. Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment: a prospective randomized multicenter clinical study. 

Idrees S, Sridhar J, Kuriyan AE. Proliferative vitreoretinopathy: a review. 

Xiang J, Fan J, Wang J. Risk factors for proliferative vitreoretinopathy after retinal detachment surgery: a systematic review and meta-analysis. 

Tseng W, Cortez RT, Ramirez G, Stinnett S, Jaffe GJ. Prevalence and risk factors for proliferative vitreoretinopathy in eyes with rhegmatogenous retinal detachment but no previous vitreoretinal surgery. 

Eliott D, Stryjewski TP, Andreoli MT, Andreoli CM. Smoking is a risk factor for proliferative vitreoretinopathy after traumatic retinal detachment. 

Wang MTM, Danesh-Meyer HV. Cannabinoids and the eye. 

Ryz NR, Remillard DJ, Russo EB. Cannabis roots: a traditional therapy with future potential for treating inflammation and pain. 

El-Remessy AB, Al-Shabrawey M, Khalifa Y, Tsai NT, Caldwell RB, Liou GI. Neuroprotective and blood-retinal barrier-preserving effects of cannabidiol in experimental diabetes. 

Liou GI, Auchampach JA, Hillard CJ, et al. Mediation of cannabidiol anti-inflammation in the retina by equilibrative nucleoside transporter and A2A adenosine receptor. 

El-Remessy AB, Khalil IE, Matragoon S, et al. Neuroprotective effect of (−)Δ

- tetrahydrocannabinol and cannabidiol in N-methyl-D-aspartate-induced retinal neurotoxicity: involvement of peroxynitrite. 

Zong AM, Barmettler A. Effect of cannabis usage on thyroid eye disease. 

Bondok M, Nguyen AXL, Lando L, Wu AY. Adverse ocular impact and emerging therapeutic potential of cannabis and cannabinoids: a narrative review. 

Cannabis has been shown to reduce microglial activity, expression of inflammatory cytokines and retinal neurotoxicity

Study data link cannabis use to lower risk of proliferative vitreoretinopathy after retinal detachment repair

Heidelberg Engineering has announced the launch of ZinserLab, an innovation hub that will focus on accelerating the development of imaging technologies in eye care.

 The hub is named in honour of the company’s late cofounder Gerhard Zinser, PhD, according to a news release.

“Gerhard Zinser was instrumental in building Heidelberg Engineering’s reputation for precision, excellence and purpose. As a physicist and entrepreneur, he combined scientific rigor with clinical insight to bring transformative imaging solutions to ophthalmology. Now, also as part of the EssilorLuxottica Group, Heidelberg Engineering continues this legacy with the creation of the ZinserLab—a clear expression of our enduring commitment to innovation,” said Arianna Schoess Vargas and Kfir Azoulay, managing directors of Heidelberg Engineering, in the release.

“It is designed to facilitate the transition from pioneering research to scientifically validated solutions—addressing real-world needs in ophthalmic imaging and ultimately providing clinical value. Like Gerhard, we strive to speak with researchers, clinicians, and R&D teams at eye level and drive technological innovation in eye care. His spirit is exactly what we aim to carry forward”, said Sebastian Rausch, PhD, clinical development manager for Investigational Technologies, and Roland Rocholz, PhD, technology and innovation manager. Rausch and Rocholz are the recently appointed co-leaders of the ZinserLab.

Heidelberg and Orbis also shared details of their partnership, working toward the goal of improving eye health services in underserved areas. The partnership builds on the companies’ collaboration from prior years. The joint effort will fund teaching opportunities for eye care professionals and support global training efforts through Orbis’s telemedicine and e-learning platform Cybersight. Last year’s partnership launched four live webinars, with four more virtual training sessions to be held throughout 2025.

“At Orbis, we believe that everyone, no matter where they live, deserves access to quality eye care,” Hunter Cherwek, vice president of Clinical Services and Technologies at Orbis International, said in a news release.

 “Our partnership with Heidelberg Engineering is instrumental as it allows us to collaborate on sharing information about cutting-edge technology and expertise with eye care professionals around the world including in communities with limited resources. Together, we are not only improving skills, but also working to save sight and transform futures.”

In 2024, sessions focused on optical coherence tomography and its ability to enhance the diagnosis, management and treatment of ophthalmic conditions and were joined over 2000 times by eye care professionals.

 Some of those attendees logged on from areas of the globe that experience challenging environments to access learning and mentorship services, including Afghanistan, Somalia and Ukraine, according to the release.

The first webinar of 2025 was held on 9 June and discussed novel diagnostic tools for optic neuropathies and glaucoma. More information on upcoming webinars will be made available on Cybersight’s 

Additionally, the partnership established last year enabled Heidelberg to support Orbis in its research project in retinoblastoma. The company’s study, which was published in 

 found that telemedicine significantly improved care and increase survival rates in children with retinoblastoma, with virtual mentorship capable of enhances diagnosis, disease classification and treatment outcomes.

Heidelberg Engineering launches ZinserLab to accelerate imaging innovation in eye care. News release. Heidelberg Engineering. June 16, 2025. Accessed June 16, 2025. 

https://www.heidelbergengineering.com/us/press-releases/heidelberg-engineering-launches-zinserlab/

Orbis and Heidelberg Engineering extends visionary partnership to tackle global blindness. News release. June 2, 2025. Accessed June 16, 2025. 

https://www.heidelbergengineering.com/us/press-releases/orbis-and-heidelberg-engineering-extends-visionary-partnership-to-tackle-global-blindness/

The imaging innovation project is named after the company's co-founder Gerhard Zinser, PhD

Heidelberg Engineering launches ZinserLab innovation hub, expands Orbis collaboration

The European Commission (EC) has granted a label extension in the European Union (EU) for aflibercept 8 mg (Eylea) with extended treatment intervals of up to 6 months for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME).

Christine Roth, executive vice president at Bayer commented on the Commission’s decision in a press release from the company.

“Extended treatment intervals with Eylea 8 mg can significantly decrease the frequency of injections and clinic visits for patients without compromising efficacy,” said Roth. “This translates to decreased burden of disease for patients and may enhance adherence to treatment. For ophthalmologists, it allows for greater capacity to treat additional patients. Given its distinctive product profile, Eylea 8 mg has the potential to establish a new standard of care for retinal diseases.”

The company noted that the EC’s decision was based on additional positive results from the third year open-label extension phase of the pivotal clinical trials PULSAR in nAMD and PHOTON in DME. In both extension phases (study weeks 96-156), patients originally randomized to Eylea 8 mg at week 0 maintained their visual and anatomic improvements, with 24% of patients in nAMD and 28% of patients in DME having a last assigned dosing interval of 6 months at the end of 3 years.

The company also noted that the safety profile of Eylea 8 mg continued to be favourable in the third year in both studies and is consistent with Eylea 2 mg. Eylea 8 mg (Eylea HD in the US) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg and Eylea HD in the US. Bayer has licensed the exclusive marketing rights outside the US, where the companies equally share the profits from sales of Eylea 2 mg and Eylea 8 mg.

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME. Published June 28, 2025. Accessed June 30, 2025. 

https://www.bayer.com/media/en-us/eylea-8-mg-with-extended-6-month-treatment-interval-approved-in-the-eu/

With fewer injections and sustained vision gains, the updated Eylea regimen offers new hope for patients with age-related macular degeneration and diabetic macular edema.

Prof. Robert P Finger

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