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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

On Tuesday, 11 March, Her Royal Highness the Duchess of Edinburgh, delivered a keynote address to United Nations ambassadors and agency staff advocating for gender equity in eye health. Her Royal Highness is a global ambassador for the International Agency for the Prevention of Blindness (IAPB), and as part of this role, she delivered the keynote at a UN Friends of Vision group meeting, presented in partnership with The Fred Hollows Foundation. 

The event was timed to coincide with the UN Commission on the Status of Women, shortly after International Women’s Day and during Women’s History Month in the US.

Her Royal Highness called on policymakers, health care leaders and UN ambassadors to take action and support eye care access, particularly for women and girls. In her speech, she emphasised the far-reaching impact of ocular health initiatives.

“Eye health is not simply one health concern, but can be a proactive driver of development,” the Duchess of Edinburgh said. “The ability to see is directly linked to productivity and participation, impacting families, communities and economies.”

Her Royal Highness cited programmes in Vanuatu and Vietnam, aimed at trachoma elimination, as examples of successful eye health initiatives. Vanuatu and Vietnam recently achieved trachoma-free status, per the World Health Organisation. The data-driven eye health programmes which made this possible have also illuminated the gender discrepancies that are endemic to many countries, she pointed out. 

"We now have confirmation that women are disproportionately affected by trachoma through gender issues including high contact with children, repeated infections, low uptake or access to services for women,” Her Royal Highness said.

Additionally, the Duchess of Edinburgh spoke about the UN Resolution Vision for Everyone, and the upcoming Global Summit for Eye Health organised by the IAPB. "We now find ourselves at a moment in time when universal eye health could be accessible to everyone, globally," she said. "I thank you for your attention on this vital cause, which unlike many other complex challenges being discussed this week [during the UN Commission on the Status of Women], is simple, impactful, cost-effective and scalable."

Jennifer Gersbeck, executive director of influence and scaling impact at the Fred Hollows Foundation, shared additional statistics to emphasise the global import of ocular health measures.

“Women and girls make up 55% of the world’s blind and vision impaired, yet when they can’t access the eye care that they need, it entrenches them further in poverty. Without urgent action, millions of women and girls will continue to be left behind,” she stated. “The Commission on the Status of Women is a critical opportunity to advocate for concrete policies and investment to ensure all women and girls have access to quality eye care, unlocking their full potential.”

Her Royal Highness also said that addressing eye health furthers the UN objective to achieve its Sustainable Development Goal (SDG) agenda. “By tackling the issue of blinding trachoma, as well as other eye health issues within vulnerable communities, we are also positively impacting other neglected tropical diseases,” she said. “We are also aligning our priorities with broader health and development targets, but prioritising eye health working towards achieving the SDGs by 2030."

Duchess of Edinburgh Highlights Critical Link Between Eye Health & Gender Equity at UN Commission on the Status of Women. Press release. International Agency for the Prevention of Blindness. Published March 11, 2025. Accessed March 12, 2025. 

https://www.iapb.org/news/duchess-of-edinburgh-highlights-critical-link-between-eye-health-gender-equity-at-un-commission-on-the-status-of-women/

Speech by HRH The Duchess of Edinburgh, Global Ambassador for the International Agency for the Prevention of Blindness. Published March 11, 2025. Accessed March 12, 2025.

The UN Friends of Vision group meeting coincided with International Women's Day and the UN Commission on the Status of Women

Her Royal Highness The Duchess of Edinburgh delivers keynote address on gender equity in eye care

Miguel A. Quiroz-Reyes, MD, PhD, and colleagues found that cigarette smoking negatively affects the choroidal vascularity, as indicated by a significant reduction of the choroidal vascularity index (CVI).

The investigators are from The Retina Department of Oftalmologia Integral ABC Medical and Surgical Nonprofit Organization, National Autonomous University of Mexico, Lomas de Chapultepec, and the Juarez Hospital, Public Assistance Institution, both in Mexico City, Mexico.

They explained that smoking seems to have major ocular effects, in that it “increases oxidative stress that affects the vascular endothelium by decreasing the antioxidant vitamin C and disrupting regular nitric oxide activity." In addition, the authors wrote, "Smoking reduces blood flow in the retina and choroid due to increased vascular resistance and compromised choroidal blood flow regulation compared to nonsmokers."

The negative effects of smoking on ocular tissues are well known and include age-related macular degeneration (AMD), diabetic retinopathy, cataracts, contact lens-related keratitis, Graves’ ophthalmopathy,

 Although the specific pathophysiological mechanism involved remains unclear, endothelial dysfunction is believed to play a pivotal role in the development of smoking-induced vascular diseases, according to Wimpissinger et al.

They carried out a meta-analysis that included numerous studies identified in Web of Science, Medline, PubMed, and Embase. They included observational studies to explore the relationships between smoking and ocular parameters such as the CVI and full retinal/choroidal thicknesses.

Four out of the 743 identified articles, involving 702 eyes, met the inclusion criteria. The analysis revealed a significant reduction in the CVI among smokers (standard mean difference:

-0.61, 95% confidence interval [CI]: -0.78 to -0.43, 

 < 0.00001), indicating compromised choroidal vascularity,” the authors reported.

In contrast, the impact of smoking on the subfoveal choroidal thickness (SFCT) did not reach significance (mean difference: 3.88 μm, 95% CI: -7.34-15.10, 

 = 0.50), with high heterogeneity (I² = 79%). The full-retinal thickness (FRT) also did not differ significantly between smokers and nonsmokers.

They also suggested that the mean CVI values decreased as the smoking intensity increases, suggests dose-dependency.

“Cigarette smoking negatively affects choroidal vascularity, as indicated by a significant reduction in the CVI. However, its impact on the FRT and SFCT remains unclear and requires further research. These findings highlight the importance of smoking cessation for eye health and suggest that CVI is a valuable noninvasive predictive biomarker for monitoring vascular changes in smokers,” the investigators concluded.

Quiroz-Reyes MA, Quiroz-Gonzalez EA, Quiroz-Gonzalez MA, Lima-Gomez V. 

Effects of cigarette smoking on retinal thickness and choroidal vascularity index: a systematic review and meta-analysis

https://doi.org/10.1186/s40942-025-00646-9

Wimpissinger B, et al. Effects of isometric exercise on subfoveal choroidal blood flow in smokers and nonsmokers. 

Asfar T, Lam BL, Lee DJ. Smoking causes blindness: time for eye care professionals to join the fight against tobacco. 

Galor A, Lee DJ. Effects of smoking on ocular health. 

Nita M, Grzybowski A. Smoking and eye pathologies. A systemic review. Part II. Retina diseases, uveitis, optic neuropathies, thyroid-associated orbitopathy. 

Mitchell P,LiewG, Gopinath B,Wong TY. Age-related macular degeneration. 

 MA, Martin-Calvo N, Fernandez-Montero A, 

 J. Smoking and incidence of glaucoma: the SUN cohort. 

 2017;96; https://doi.org/10.1097/md.0000000000005761

The investigators' findings suggest that CVI is a valuable noninvasive predictive biomarker for monitoring vascular changes in patients who smoke

Study: Cigarette smoking negatively affects choroidal vascularity

Clinical stage company Cognition Therapeutics has announced the publication of data from a manuscript reviewing recent work supporting the potential of zervimesine (CT1812), a small molecule drug candidate to treat dry age-related macular degeneration (AMD).

The studies included in the manuscript include an analysis of cerebrospinal fluid (CSF) collected from participants of 2 Alzheimer disease clinical trials to identify the impact of zervimesine treatment on disease-relevant proteins, a separate analysis of said CSF samples to identify pathways associated with dry AMD that were altered by treatment with zervimesine and an in vitro study that investigated zervimesine’s ability to rescue important cellular processes in a cell model of dry AMD. The in vitro study was conducted in collaboration with researchers at the University of Southhampton in the UK.

“We analysed CSF samples from studies of zervimesine in adults with mild-to-moderate Alzheimer’s disease,” said Mary Hamby, PhD, vice president of Cognition Therapeutics, in the release. “From this, we found that treatment with zervimesine altered proteins and pathways strongly associated with geographic atrophy (GA) and macular degeneration. These findings support the potential of zervimesine to impact pathways impaired in retinal diseases.”

“Retinal pigment epithelial (RPE) cells are responsible for breaking down the cellular debris generated by photoreceptors, which are specialised cells in the retina necessary for sight,” stated Arjuna Ratnayaka, PhD, who worked on the in vitro study with Cognition Therapeutics, in the release. “The ability of RPE cells to carry out this function is essential for the health and survival of photoreceptors. We modeled this in the laboratory and showed that RPE cells’ capacity to break down photoreceptor outer segments (debris) was compromised when when the cells are exposed to amyloid beta oligomers or oxidative stress. However, the addition of zervimesine and other compounds from Cognition Therapeutics’ library normalized the function of RPE cells.”

Additionally, Cognition Therapeutics reported a positive outcome of an analysis of masked data from its ongoing MAGNIFY Phase 2 trial for zervimesine (CT1812) in adults with GA secondary to dry AMD.

 Results from the futility analysis show that the first 57 participants who completed at least 6 months of dosing showed that zervimesine-treated patients were experiencing a slower lesion growth rate compared to placebo, according to a news release.

The MAGNIFY study has enrolled 100 participants so far, who were scheduled to complete a final clinic visit in February 2025. Cognition Therapeutics intends to unblind the study at the end of February and complete analysis of the study, including 12 months of dosing, in Q2 2025.

Zervimesine is an investigational oral, once-daily pill being developed for the treatment of CNS diseases including Alzheimer disease and dementia with Lewy bodies. Although Cognition Therapeutics believes that zervimesine has the potential to alter the biological processes that contribute to dry AMD, the company still intends to focus its financial resources on Alzheimer disease and dementia in Lewy bodies.

 Concluding the MAGNIFY study early will allow the company to then preserve financial resources for other indications.

Cognition Therapeutics publishes research supporting the potential of zervimesine in dry AMD. News release. Cognition Therapeutics. February 27, 2025. Accessed February 28, 2025. 

https://www.globenewswire.com/news-release/2025/02/27/3033753/0/en/Cognition-Therapeutics-Publishes-Research-Supporting-the-Potential-of-Zervimesine-in-Dry-AMD.html

Cognition Therapeutics successfully passes predefined futility analysis of Phase 2 study of oral zervimesine (CT1812) in geographic atrophy. News release. Cognition Therapeutics. February 26, 2025. Accessed February 28, 2025. 

https://www.globenewswire.com/news-release/2025/02/26/3032770/0/en/Cognition-Therapeutics-Successfully-Passes-Pre-defined-Futility-Analysis-of-Phase-2-Study-of-Oral-Zervimesine-CT1812-in-Geographic-Atrophy.html

One in vitro study included in the manuscript was conducted in collaboration with researchers at the University of Southhampton in the United Kingdom

Sponsored by Biogen

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