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While traditional transscleral cyclophotocoagulation is effective at lowering IOP in patients with glaucoma, it has a high rate of side effects. The new MicroPulse system is effective and affordable with an excellent safety profile.

Redefining cyclophotocoagulation with modified laser delivery [ABSTRACT]

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

For a patient undergoing cataract surgery, the primary post-operative expectation is improved vision. As a surgeon, achieving the desired refractive outcome involves several critical steps: conducting precise preoperative measurements, selecting the appropriate IOL technology and power, and performing surgery with accuracy.

Heidelberg Engineering’s advanced diagnostic imaging solutions support you in enhancing the cataract patient journey, from initial assessment and diagnosis to preoperative planning and postoperative monitoring. Throughout this interactive supplement, leading surgeons share their experiences with and discuss the advantages of these advanced diagnostic imaging solutions, as Dr. James Lewis does in this video 

A major challenge for cataract surgeons is the vast number of patients. Addressing this backlog is crucial to prevent vision impairment and improve the quality of life for those affected. The electronic medical record, Heidelberg Eye Explorer 

, helps to streamline the cataract workflow by optimising patient data management, enhancing communication, and improving surgical planning.

Dr. Hackl from Hanusch Hospital in Vienna recalls how HEYEX EMR streamlined their workflow and provided access to patient records across more than five locations.

“There was a need to have a paperless medical record which could be seen in all five locations and met our main requirements: a continuous medical record, a patient summary for a quick overview, as well as planning and documentation…when a system like HEYEX EMR supports structured data the possibilities to use the data are unlimited." 


Read the full story on how Hanusch Hospital, Vienna, used HEYEX EMR to streamline their workflow.

 image and data management platform into your clinic workflow allows for improved efficiency. All patient information is centrally recorded and can be accessed anywhere in the clinic. Images and data are immediately available on your desired device, viewing station, and in the patient record.

Visualising all relevant data and images from the cataract workup contributes to an optimal diagnostic workflow, facilitates confident decisions, and assists you in easily identifying potential sources of complication.

Precise ocular biometry is critical for determining the power of IOLs being implanted. Leveraging advanced Swept-Source OCT technology, 

 provides you with a comprehensive, all-in-one solution for optical biometry and IOL power prediction. In a single imaging session, the Cataract App provides precise and accurate measurements traditionally delivered by several devices, including axial length, cornea topography and tomography, anterior chamber depth, lens thickness, white-to-white, and central corneal thickness.

“I was looking to upgrade my methods and equipment, especially in intraocular lens calculation, explains Dr Arturo Chayet, ophthalmologist and founder of CODET Vision Institute in Tijuana, Baja California, Mexico. At the time, I was using the IOLMaster500 for calculations, but I was looking for a bridge to swept-source OCT technology. We knew it was crucial to not only measure axial length and various parameters of the eye but also to understand the anterior chamber, specifically the effective lens position. I was struck by the capability of ANTERION and was very impressed with the expertise Heidelberg Engineering has in the field. Our experience with SPECTRALIS was excellent as well.” 
- Dr. Arturo Chayet, M.D. 

Learn more about ‘Biometry for IOL Power Prediction’ in this 

 that provides detailed information on preoperative diagnostics, including corneal maps and biometry parameters relevant for IOL power prediction.

For refractive IOL procedures, where presbyopia-correcting IOLs are implanted, and in challenging cases, accessing additional data is essential for patient selection and satisfaction. ANTERION provides a comprehensive analysis of the cornea and includes details on astigmatism and corneal wavefront. 

Learn more about the significant role ANTERION plays in premium IOL selection here.

ANTERION’s high-resolution imaging of the anterior segment can help you prevent unexpected results by identifying complex ocular properties relating to anatomy, visual quality, and atypical geometry of the anterior segment. The high-quality images also provide visual aids that can be used to explain your patient’s condition and the planned surgical procedure, enhancing their understanding and compliance.

Listen to Dr. Pooja Kumar, Consultant, Khetarpal Hospital, New Delhi, India 

, as she explains how she uses ANTERION’s high-resolution swept-source OCT images to identify complex cases like posterior polar cataracts. She also explains how she utilizes these images to counsel her patients in preparation for surgery.

OCT imaging of the retina before cataract surgery lets you assess pathologies that may limit visual outcomes. 

 allows you to choose between 20kHz, 85kHz and 125KHz depending on your needs. 20 kHz scan speed offers high-quality retinal imaging also in eyes with media opacities often caused by cataracts. 

Read more about the benefits of retinal OCT before cataract surgery here

 provides a comprehensive overview by combining data and images from all devices 

. This consolidated information ensures you have all relevant diagnostic details, enhancing your confidence in surgical planning.

 delivers next-generation image technology to revolutionise your surgical practice. It brings together innovative design and 3D technology to set new standards in surgical precision and surgeon comfort during procedures.

 as he shares his initial impressions and discusses the benefits of SeeLuma, explaining why he eagerly anticipates incorporating it into his practice soon.

High-Resolution Imaging for Postoperative Evaluation

 supports you in visualising the success of surgical procedures by comparing pre- and post-op images and measurements. Detailed anterior chamber information from high-resolution SS-OCT images helps you assess cataract surgery outcomes, including IOL placement, ensuring optimal patient care and satisfaction 

Watch this Healio video interview with Dr. Mitchell W. Dul, OD, 

where he explains how he uses the ANTERION Metrics App to show his patients their pre-op and post-op configurations, helping them become more invested in their care.

Leveraging Heidelberg Engineering's advanced diagnostic tools and technologies, including high-quality OCT imaging, precise biometry, and corneal topography and tomography, enhances your diagnostic accuracy, surgical planning, and postoperative evaluation. Whether dealing with standard, refractive IOL, or challenging cases, these tools and technologies can help you improve patient outcomes and engagement, streamline workflows, and flag potential surgical complications.

Disclaimer: Not all features are available for sale in all countries

Enhancing the Patient Journey: Solutions for Streamlining Success in Cataract Surgery

Glaucoma specialists worldwide face numerous challenges daily, from early detection to accurate diagnosis and ongoing patient management. The Heidelberg Engineering Glaucoma Workflow Solution is designed to provide the tools you need to deliver the best care to your patients. It offers dynamic visualization of parameters, efficient data management, precise imaging, and robust monitoring capabilities. Find out how glaucoma experts around the world are leveraging these advanced technologies to enhance the patient journey, increase diagnostic confidence, streamline workflows, and improve patient outcomes.

“It was a surprise as I didn’t feel my vision had been hindered in any way. At that point, I didn’t know that glaucoma was rampant in my family on both my mother’s and father’s sides. When I shared the news of my glaucoma with my late mother, she did not miss a beat, replying, ‘Oh honey, your father and I have had glaucoma for years’. To which I could only say, ‘Really Mom, maybe you and Dad could’ve mentioned that […] like 20 years earlier.” PHILLIP VAN LEAR, diagnosed at 48 

One of the most significant challenges in glaucoma management is detecting the disease early, as it often progresses without symptoms. “

Early glaucoma has no symptoms,” explains Christian Mardin, Consultant Ophthalmologist at Friedrich-Alexander-Universität, Erlangen, Germany. “Every person over 40 should go to their optometrist or ophthalmologist to get their optic nerve head checked

Continue reading Prof. Mardin’s insights on early glaucoma detection here.

 helps streamline this process by managing and presenting comprehensive ophthalmic patient records through an intuitive interface. It provides access to high-quality, structured data, aiding in efficient reporting and auditing. Dr. Hackl of Hanusch Hospital, Vienna, recalls how HEYEX EMR helped the hospital streamline their workflow and allowed access to patient records in over five locations.

“There was a need to have a paperless medical record which could be seen in all five locations and met our main requirements: a continuous medical record, a patient summary for quick overview, as well as planning and documentation…when a system like HEYEX EMR supports structured data the possibilities to use the data are unlimited.

Read the full story on how Hanusch Hospital, Vienna, used HEYEX EMR to streamline their workflow.

As early detection becomes more efficient, the next step is ensuring accurate diagnosis, where the 

The Glaucoma Module Premium Edition (GMPE)

 provides detailed imaging and analytics of the optic nerve head and retinal nerve fiber layer. Using the Anatomic Positioning System (APS) ensures an accurate anatomical setup for optimal comparison with the normative reference database. These tools equip you with the information needed to support confident diagnostic decisions. 

Download the SPECTRALIS Glaucoma Toolkit here.

 allows for non-contact assessment of iridocorneal angles and anterior segment anatomy, providing precise measurements and automatic identification of the scleral spur to enhance your early detection capabilities. 

Dr. Benjamin Xu, Chief of the University of Southern California's Glaucoma Service, presents a webinar on using non-invasive anterior segment imaging, including ANTERION® technology and AI, to detect and treat angle closure glaucoma. 

Once a confident diagnosis is achieved, effective management relies on seamless referrals and data sharing, which is where the integration of HEYEX EMR with the 

 platform becomes indispensable. Effective glaucoma management necessitates streamlined referrals and data sharing throughout your clinic. This system centralizes patient information, minimizing duplication and manual data entry errors.

HEYEX 2 Cloud Exchange facilitates secure, peer-to-peer transfer of images and data over the internet, eliminating the need for VPN connections. This feature enables efficient and encrypted data transfers, ensuring timely communication with other healthcare providers and enhancing your referral process. Learn to start using Cloud Exchange and transfer data after setting it up on 

 enhances your diagnostic workflows by enabling side-by-side review of images and reports from both eyes, consolidating all pertinent data for comprehensive analysis, in one single view.

“I have chanced upon signs which masquerade as glaucoma on an OCT scan. Branch retinal artery occlusions or cotton wool spots — small infarcts or blood vessel closures — can result in an initial swelling in the nerve fibre layer. They are transient and disappear in a few weeks, and are often caused by high blood pressure or kidney disease.” 

PROF. SANJAY ASRANI, Duke Eye Center, North Carolina, USA 

Accurate glaucoma diagnosis hinges on comprehensive examination techniques. The SPECTRALIS GMPE provides accurate measurements and visualization of key parameters involved in glaucoma diagnosis such as the optic nerve head, retinal nerve fibre layer, and macular ganglion cell layer, via OCT imaging. Tools like Bruch’s Membrane Opening – Minimum Rim Width (BMO-MRW) offer objective, geometrically accurate measurements of the neuro-retinal rim, aiding your early detection efforts. The reference database further guides your analyses.

Learn to integrate the power of OCT imaging and SPECTRALIS GMPE in your daily practice in this educational webinar by Dr. Swarup Swaminathan. 

Sometimes glaucoma needs to be differentiated from other conditions with similar presentations. Recognizing these nuances ensures your accurate diagnosis and effective treatment planning.

Regular monitoring is critical for managing glaucoma patients. The HEYEX 2 Multimodality Viewer supports ongoing data sharing and displays follow-up examinations across multiple locations, allowing you to access previous images and reports easily. Post-surgery, the ANTERION Metrics App provides precise measurements and visualizations of the anterior chamber and the anterior chamber angle, crucial for effective patient management.

Integration with the SPECTRALIS core technologies, such as TruTrack Active Eye Tracking and AutoRescan, ensures accurate monitoring of disease progression. These tools enable follow-up scans in the exact anatomical locations as previous exams, allowing you to detect minute changes with high precision.

, the world's first fully digital microscope, offers unparalleled precision through its 3D visualization technology. It provides exceptional image quality, ergonomics, and educational features, significantly benefiting your surgical practice.

The Heidelberg Engineering Glaucoma Workflow Solution is designed to integrate seamlessly into your patient care routine, supporting unparalleled diagnostic confidence and efficiency. By leveraging these advanced tools and technologies, you can overcome the challenges in glaucoma management, improving patient outcomes and engagement.

Delve deeper into how these solutions can transform your practice.

Enhancing the Patient Journey: Solutions to Overcoming Challenges in Glaucoma Management

Clinical stage company Cognition Therapeutics has announced the publication of data from a review of 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

Nathan M. Radcliffe, MD

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