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FDA decision changes scope of healthcare delivery; increases patient access to early detection of DR

Applying AI in fundus images

The spectrum of central serous retinopathy

How FAME data may assist in DME treatment decisions

Twelve-month results of the FILLY trial show that in patients with geographic atrophy, the administration of complement C3 inhibitor APL-2 slowed the growth rate of the disease. It also appeared to increase the risk of new onset AMD, although this did not have an adverse effect on visual outcomes.

APL-2 slows growth of GA in phase II safety and efficacy trial

A recently released ultra-widefield fundus camera takes images in true color and captures high-resolution imagess rom the macula to the far periphery.

Ultra-widefield camera captures images from macula, far periphery

Researchers have identified a new biomarker they believe can be used as a predictor of vision change in patients with diabetic macular edema, either during the natural history of the disease or after undergoing anti-VEGF therapy. The biomarker is disorganization of the retinal inner layers, or DRIL.

New biomarker may predict treatment response in DME

AAO 2024: Fundus photography/OCT expediates care in the emergency department

Valerie Biousse, MD, from the Emory University in Atlanta, Georgia, shared insights on how ocular imaging in the emergency department can provide timely, accurate diagnosis while also benefiting the on-call ophthalmologists. She shared these thoughts at this year's AAO meeting held in Chicago, Illinois. 

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

I am Valerie Biousse, a neuro-ophthalmologist at Emory University in Atlanta. I am a big fan of having non-mydriatic fundus cameras in emergency departments, and we have a few presentations on this topic at the AAO meeting.

As you know, nobody really uses ophthalmoscopes in emergency departments anymore, and cameras are great because they facilitate the examination of the ocular fundus by non ophthalmologists, and they also allow for remote interpretation of the pictures by ophthalmologists. So instead of ophthalmoscopes, we have a camera connected to our electronic health record with an entirely automated process and integration of the camera into the ED flow. 

This has proven very useful, because the camera allows the ophthalmologist on call to make some diagnosis remotely, without in person consultation. So for example, if an acute central retinol artery occlusion is abuse on ocular imaging, we do not even come to the hospital anymore, and instead, we trigger a stroke alert, which prompts neurology to take care of the patient immediately, and not having to wait for an ophthalmologist to come to the emergency department or wait for pupillary dilation to look at the fundus is saving a lot of time, and it is allowing us to occasionally recommend treatment of acute central retinol artery oclusion with thrombolysis within just a few hours of vision loss, which is amazing. That has allowed us to design a nice stroke protocol, which has become standard of care at our institution. 

Another great use of the camera in the emergency department is when a patient has headaches or is sent to the emergency department to roll out papilledema, presumably from a neurologic disorder. In this case, we just review the pictures remotely, instead of having to come to the ED in the middle of the night for a fundus examination. We showed that this new flow has reduced the ED length of stay by at least 50% for patients sent to the ED mostly to rule out papilledema, and that more than 90% of patients were able to have papilledema ruled out remotely, without an in-person consultation. And you can imagine that this has made our on-call ophthalmologists, including our residents, very happy. So these are the main reasons why I think we really need to work at helping our emergency department colleagues implement such cameras in general emergency departments, especially given the anticipated worsening shortage of ophthalmologists and neuro-ophthalmologists in our country. 

Being able to provide adequate ophthalmic examinations in the ED, including remotely, with either implementation of e-consultation or teleophthalmology will become essential, and cameras will help us do that. To take the pictures are obtained directly by the ED staff, and anyone can do it. Currently, we have the technicians who are in charge of doing EKGs in the ED, they were trained. The training takes about 10 minutes. They take the pictures themselves, and that's why the key is to have a very user-friendly camera with only 1 button to push and the pictures happen. 

The interpretation is a little more complex. The pictures are readily available to the ED providers and to the neurologists on the electronic medical records. Some of them are comfortable reviewing the pictures themselves, and they interpret them without our help. And it's particularly useful when the pictures are normal. So for example, if all they want to do is rule out papilledema, then in most situations, they do it themselves, and they don't even call us. 

On the other hand, if the picture looks abnormal, they page us, and we review the pictures live for them so that they get an immediate interpretation. In all cases, I always reassure them. We tell them, "we have your back," because in all cases, 1 ophthalmologist reviews the pictures, usually within 24 hours, in order to double check that the original interpretation was correct and to be able to bill.

Valerie Biousse, MD, from the Emory University in Atlanta, Georgia, shared insights on how ocular imaging in the emergency department can provide timely, accurate diagnosis while also benefiting the on-call ophthalmologists.  

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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.

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.

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.

Steve Lenier

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