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Vitreoretinal Specialist
Westchester Medical Center
Assistant Professor, New York Medical College
Valhalla, New York

Ferhina S. Ali, MD, discussed the real-world efficacy and durability of next-generation anti-VEGF agents like faricimab and aflibercept 8 mg, emphasizing how large-scale data offers insights into their performance and safety beyond clinical trials.

OSN New York Retina 2024: Understanding how next-generation anti-VEGFs perform in real-world settings compared to trials

EURETINA 2024: Ali Erginay, MD, Red-Blue-Green (RGB) imaging modalities

Ali Erginay, MD, MD, spoke about the important developments in retinal imaging, specifically the Red-Blue-Green (RGB) imaging modalities during his interview with 

, which took place at the EURETINA 2024 meeting held in Barcelona, Spain, on September 19-22, 2024.

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

I'm Dr Ali Erginay. I'm working in [Lariboisière Hospital in] Paris. Our department specializes in retina and retinal imaging. So I had the chance to try, at the very beginning of time, Optos, and I could see all the evolutions of Optos. Recently, the most pronounced, most important development was the integration of RBG color wavelengths. It changed everything, because there were a lot of critics about OCT. People used to say that the images were a little bit greenish. And the critics were right, it was true, it was greenish. But with the addition of blue wave light, it changed everything, because colors became more beautiful.

At the beginning, we were very influenced by the beauty of the images. Then we realized that this was not only a question of beauty: The images were better, more detailed, to facilitate the diagnosis. In my presentation yesterday, I exposed our study that we did in Lariboisière Hospital. We have had chance to have both cameras, side by side. So we chosen about more than about 165 eyes of 200 patients, and we did the examination with both cameras, with 10 minutes of [inaudible]. We realized that with this filter, with this wavelength, with this laser, we could penetrate better. And we saw that with this new technique, you can have better images, even with the cataract. The presence of cataract is very important, because most of the diabetic patients have medium [inaudible]. So even with the cataract, we did 10-minute of intervals in the same patient. It was dramatically better. Even now, I can't explain it. So that's why we decided to do this study.

And we were not very surprised. The study showed us that we could better detect abnormalities, hemorrhages, microaneurysms and intraretinal micro abnormality earmarks better with the new system. Of course, when you detect all those lesions, you can do classification reading much better. And we saw the severity of diabetic patients were a little bit higher with the RGB system. So it's very important.

In conclusion, I can say that images are not only more beautiful, but it improves the diagnosis and detection of lesions. And it's not true only for diabetic patients. Even autofluorescein photos are better. If you have a geographic atrophy or whatever, even lesions in the periphery, retinal detachment, retinal holes, you see them better. The colors are better, and your diagnosis and detection of lesions getting better. So how can we ask for more?

There are a lot of exciting things [at EURETINA], first about new treatments. I saw that geographic atrophy is becoming at last, very dominant. Until now, we've been so focused on wet AMD. Now we are focused on geographic atrophies, and there are new treatments. That's a good thing. And genetic therapy is improving also. And then, third of course, imaging techniques, new machines, especially ultra wide field imaging, including OCT, OCT-A and color photos. Having all those cameras is not enough, because the population is growing. We're getting more and more, we have more and more patients. So artificial intelligence is developing also. They can be integrated into new machines, so they can be used for diagnosis and treatment decision. Those are the points that I like a lot.

Ali Erginay, MD, spoke about the important developments in retinal imaging, specifically the Red-Blue-Green (RGB) imaging modalities during his interview with Ophthalmology Times Europe, which took place at the EURETINA 2024 meeting held in Barcelona, Spain, on September 19-22, 2024.

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EURETINA 2024: Ali Erginay, MD, speaks about Red-Blue-Green (RGB) imaging modalities

The Food and Drug Administration (FDA) announced its approval of 2 biosimilars as interchangeable with aflibercept 2 mg (Eylea).

The agency approved aflibercept-jbvf (Yesafili, Biocon Biologics) and aflibercept-yszy (Opuviz, Samsung Bioepis, Biogen). All 3 products are anti-vascular endothelial growth factor (VEGF) agents, administered intravitreally for neovascular age-related macular degeneration (nAMD). Aflibercept-jbvf and aflibercept-yszy are the first interchangeable biosimilars to aflibercept 2 mg.

In a news release, the FDA described the products as “interchangeable biosimilars,” suitable for treating patients with nAMD, macular edema following retinal vein occlusion, diabetic macular edema, and/or diabetic retinopathy. The news release went on to detail the safety profile for aflibercept-jbvf and aflibercept-yszy. 

“The side effects and adverse events observed in clinical studies of Yesafili and Opuviz are consistent with those observed with Eylea,” the agency wrote.

 “The most common (≥5%) of these side effects included conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.”

Following the FDA approval of aflibercept 8 mg (EYLEA HD) in August 2023, Regeneron has placed a focus on the higher-dose product, recording $200 million in sales in the first quarter of 2024.

Aflibercept 8 mg also received EU marketing authorization from the European Commission in January of this year.

 Biocon Biologics Limited received marketing authorization approval in the UK for aflibercept-jbvf in November 2023.

FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions. US Food & Drug Administration. May 20, 2024. Accessed May 21, 2024. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye

US FDA approves two biosimilars for blockbuster eye drug Eylea. Reuters. May 20, 2024. Accessed May 21, 2024. 

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-biocon-units-biosimilar-blockbuster-eye-drug-eylea-2024-05-20/

Hayes H. European Commission grants EU marketing authorisation for aflibercept (Eylea) 8 mg. Ophthalmology Times Europe. January 8, 2024. Accessed May 21, 2024. 

https://europe.ophthalmologytimes.com/view/european-commission-grants-eu-marketing-authorisation-for-aflibercept-eylea-8-mg

The agency approved Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis, Biogen) as biosimilars to Eylea (Regeneron Pharmaceuticals).

US FDA issues approval for two aflibercept biosimilars 

The US Food and Drug Administration (FDA) has approved biosimilar to Eylea, aflibercept-mrbb (Ahzantive), for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD).

The biosimilar has also been approved for treatment in patients with serious retinal diseases such as diabetic macular edema (DME), diabetic retinopathy (DR) and macular edema following retinal vein occlusion (RVO).

2 other aflibercept biosimilars were recently approved by the FDA

, Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis Opuviz (aflibercept-yszy).

The news was announced in a press release from biosimilar developer Formycon AG and its licensing partner Klinge Biopharma.

 CEO Stefan Glombitza, PhD, stated that the FDA approval of Ahzantive was “another key milestone on [their] way to becoming the leading pure-play biosimilar developer. It highlights the expertise and experience of [their] team.” He further stated that alongside the approved Lucentisbiosimilar FYB201, he believes the company has an “outstanding position in ophthalmic biosimilar therapies.”

According to the company, the active ingredient in Ahzantive inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

Furthermore, the company stated 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 Ahzantive demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eyleain patients with nAMD.

In addition to the FDA approval, the company also submitted a marketing authorization application with the European Medicines Agency (EMA) and expects a response by early 2025.

Formycon Receives FDA Approval for FYB203/AHZANTIVE (AFLIBERCEPT-MRBB), a biosimilar to Eylea. Press Release; July 1, 2024. Accessed July 2, 2024. 

https://www.formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive/

The biosimilar was approved for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases.

FDA approves Formycon’s biosimilar to Eylea, aflibercept-mrbb (Ahzantive) 

Altos Biologics Inc. has submitted the Marketing Authorization Application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept biosimilar. This biosimilar was developed by Alteogen. Altos Biologics Inc. is a subsidiary of Alteogen.

According to the company’s press release

, the phase 3 clinical trial for ALT-L9 began with initial clinical trial approval in 2022 and incorporated over 400 participants from 12 countries, including those in Europe, South Korea, and Japan. The study compared efficacy, safety, and immunogenicity against Eylea® in the indication of wet age-related macular degeneration (wet AMD). The primary endpoint of the study was change in best-corrected visual acuity (BCVA) over 8 weeks.

Dr. Hyi Jeong Ji, Chief Executive Officer of Altos Biologics, shared the further plans for this biosimilar in the release

, saying, "Following the European Marketing Authorization Application for ALT-L9, we plan to pursue product approvals in target markets including Korea."

Altos Biologics expects to receive approval from EMA by 2025, aligned with the substance patent expiration, and intends to negotiate License Agreements with potential distributors worldwide.

1. Altos Biologics Files Approval of Aflibercept Biosimilar. Alteogen Inc. Published July 1, 2024. Accessed July 2, 2024. https://www.morningstar.com/news/pr-newswire/20240701cn52238/altos-biologics-files-approval-of-aflibercept-biosimilar

The company expects approval from the EMA by 2025. 

Altos Biologics submits Marketing Authorization Application to the EMA for ALT-L9, an aflibercept biosimilar

Lupin has successfully completed a global, phase 3 clinical study of LUBT010. This candidate is a ranibizumab biosimilar to Lucentis. The study achieved its primary endpoint, which was equivalence in visual acuity improvement for wet AMD patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis.

Since 2022, Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes. Ranibizumab is used in the treatment of wet AMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).

, Lupin noted that the Phase 3 study was designed as a global clinical trial, in line with recommendations from European Medicines Agency (EMA) and FDA in the United States. The trial was designed to evaluate the efficacy, safety, and immunogenicity of LUBT010 versus Lucentis in patients with wet AMD. A total of 600 patients from locations in India, US, EU, and Russia were randomized in the study, who received either LUBT010 or Lucentis 0.5 mg. Both treatments were administered as an intravitreal injection once a month for 12 months. Patients were followed for efficacy, safety, and immunogenicity assessment.

Dr. Cyrus Karkaria, President of Lupin Biotech, commented on this milestone and next steps in the company's press release

, saying, “We are very pleased with the positive outcome of the global Phase 3 study, which marks yet another significant developmental milestone for our Lucentis biosimilar. It is a reaffirmation of our focus on developing high-quality biosimilars, to cater to patient needs. We will be filing marketing applications for LUBT010 in all major global markets this year.”

Similarly, Nilesh Gupta, Managing Director of Lupin noted the potential impact on patients this biosimilar may have, saying, “This achievement of our Biosimilars team demonstrates our capability to develop cutting-edge, cost-effective products. We have already commercialized four products to date and there are several more at various stages of clinical trials. We now look forward to bringing our high-quality Ranibizumab Biosimilar into the global Ophthalmic market, making a positive difference in the lives of our patients worldwide.”

The data gathered during this Phase 3 study will be part of Lupin’s application for marketing approval with the FDA and the EMA.

1. Lupin Announces Successful Completion of Phase 3 Trials for Lucentis® Biosimilar. Global Pharma major Lupin Limited. August 5, 2024. Accessed August 5, 2024. https://www.lupin.com/lupin-announces-successful-completion-of-phase-3-trials-for-lucentis-biosimilar/

LUBT010 is a ranibizumab biosimilar to Lucentis that achieved its primary endpoint in this study.

Lupin's phase 3 trials for ranibizumab biosimilar reaches primary endpoint

On Friday, September 20, 2024, Samsung Bioepis Co., Ltd., based in Korea, and Biogen Inc, based in Massachusetts, announced the European Medicines Agency (EMA) issued a positive opinion for SB15 40mg/mL (OPUVIZ). The Committee for Medicinal Products for Human Use (CHMP) issued its recommendation for marketing authorisation, which will be referred to the European Commission for approval. The CHMP’s positive opinion was based on a totality of evidence surrounding SB15, including both clinical and non-clinical data, according to a press release.

According to Samsung Bioepis and Biogen, SB15 has been recommended for approval in adult patients for the treatment of neovascular (wet) age related macular degeneration, visual impairment due to macular oedema secondary to branch or central retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularization.

A randomised, double-masked, parallel group, multicentre Phase 3 study demonstrated equivalent efficacy, as well as comparable safety, immunogenicity and phamacokinetics between SB15 and the reference product, aflibercept. These results were assessed at weei 8, the 32-week interim period and at 56 weeks.

This is the companies' second ophthalmology biosimilar to receive the recommendation. SB11 (BYOOVIZ, biosimilar ranibizumab), was awarded marketing authorisation in 2021. Samsung Bioepis and Biogen announced a commercialisation for two biosimilar candidates, SB11 and SB15, in November 2019.

Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, called the CHMP opinion a significant milestone. “The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies,” she said. “We will continue our work to transform the way biologic therapies are brought to patients and enhance the lives of patients, through our pioneering and innovative use of science and technology.”

The European Commission will decide whether to grant the marketing authorisation for SB15 following the CHMP's ruling.

Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ. Press release. Biogen. Published 20 September, 2024. Accessed 20 September, 2024. 

https://investors.biogen.com/news-releases/news-release-details/samsung-bioepis-and-biogen-receive-positive-chmp-opinion-0

The CHMP will recommend SB15, biosimilar to aflibercept (Eylea), for marketing authorisation by the European Commission

Ferhina S. Ali, MD, MPH

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