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Grace Koennecke is an Editorial Intern for MJH Life Sciences.

The updated device is designed to meet market diagnostic needs, including within geographic atrophy research

 iCare announces updated MAIA TrueColor Microperimetry System

The company, which has European headquarters in Basel, Switzerland, plans to use the funds for a non-interventional, observational study and a first-in-human clinical trial

RhyGaze announces $86 million in Series A financing for optogenetic vision restoration therapy candidate

The ALLY Adaptive Cataract Treatment System will be the first EU ALLY commercial installation

LENSAR receives certification for new adaptive cataract treatment system

The EMA issued a designation for the small molecule photoswitch, which targets inherited retinal diseases including retinitis pigmentosa

Kiora Pharmaceuticals receives Orphan Medicinal Product Designation for KIO-301 

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

Significance of the Higher Molar Dose of Aflibercept 8 mg

Video content above is prompted by the following:

Aflibercept 8 mg was recently approved for treating age-related macular degeneration and diabetic macular edema. Could you discuss the significance of the higher molar dose?

Panelists discuss how the aflibercept 8 mg higher molecular concentration enables extended durability through increased VEGF binding capacity and longer intraocular drug levels, potentially allowing for less frequent dosing while maintaining efficacy.

Video Series

As artificial intelligence (AI) begins to establish a larger presence in medical care, questions surrounding cost arise. A recent study,

 led by first author Mahoor Ahmed, MS, and colleagues found that “autonomous AI-based screening is a more effective screening strategy compared to the standard eye care provider (ECP)-performed eye examinations with greater cost-effectiveness for smaller health systems and cost-saving for larger ones.” She is from the Section on Biomedical Informatics and Data Science, Johns Hopkins University, Baltimore.

Autonomous AI already has been shown to be safe and effective for screening patients for paediatric diabetic retinal disease (DRD) and can potentially enhance health equity and clinician productivity.

However, the researchers pointed out that cost among other factors may deter patients from screening, especially in rural and low-resource settings.

 “With DRD screening rates as low as 20% nationwide,” they stated, “health systems and medical practices are considering alternative methods to increase screening access and adherence.

 Therefore, considering the financial expenditures associated with AI screening is an important step in determining if and how to implement these systems.

In this next-step study, Ahmed and colleagues examined the cost-effectiveness of an autonomous AI strategy versus a traditional ECP strategy during the initial year of implementation from a health system perspective in order to obtain some solid financial data. The incremental cost-effectiveness ratio was the main study outcome measure.

The bottom line, according to Ms Ahmed and colleagues, was that “The base-case analysis showed that the AI strategy resulted in an additional cost of $242 [€235] per patient screened to a cost saving of $140 [€127] per patient screened, depending on the health system size and patient volume, compared with the ECP strategy."

The investigators also reported that the base-case analysis showed that the anticipated AI strategy cost was between $19,368 and $133,900 (equivalent to €18,848 and €130,306, respectively), compared to that of the ECP strategy, which is between $8,927 and $357,072 (equivalent to €8,687 and €347,488, respectively). 

“Thus, excluding insurance reimbursements, the AI strategy results in additional costs of up to $10,441 [€10,160] and potential cost savings of up to $240,972 [€234,504] depending on the size of the health system. Regarding effectiveness, the AI strategy consistently results in more patients being screened, ranging between 43 and 1,724 additional patients screened annually, depending on patient volume.”

They continued, “Notably, the AI screening strategy breaks even and demonstrates cost savings when a paediatric endocrine site screens 241 or more patients annually. Autonomous AI-based screening consistently results in more patients screened with greater cost savings in most health system scenarios.”

Their hope is that this analysis can assist providers in weighing the value proposition of implementing AI screening and support informed adoption decisions.

Ahmed M, Dai T, Channa R, et al. Cost-effectiveness of AI for pediatric diabetic eye exams from a health system perspective. 

https://doi.org/10.1038/s41746-024-01382-4

Flaxel CJ, Adelman RA, Bailey ST, et al. Diabetic retinopathy preferred practice pattern®. 

Draznin B, Aroda VR, Bakris G, et al. 14. Children and adolescents: standards of medical care in diabetes—2022. 

Benoit SR, Swenor B, Geiss LS, Gregg EW, Saaddine JB. Eye care utilization among insured people with diabetes in the U.S., 2010–2014. 

Autonomous, AI-based screening consistently resulted in more patients screened with greater cost savings, investigators said

Artificial intelligence supports screening more paediatric patients at lower cost

RhyGaze, a biotechnology company based in Basel, Switzerland, and Philadelphia, Pennsylvania, announced it has secured Series A financing of $86 million. Financing was led by Google Ventures, Arch Venture Partners, F-Prime Capital and founding investors BioGeneration Ventures and Novartis Venture Fund.

The funding will aid the further development of RhyGaze’s lead clinical candidate, a novel gene therapy for optogenetic vision restoration in diseases causing blindness. It will also support activities like formal pharmacology and toxicology testing; a non-interventional, observational study to assess potential clinical endpoints in patient groups eligible for the therapy; and a first-in-human clinical trial to test the safety, tolerability and potential efficacy of the lead candidate.

RhyGaze was co-founded by Botond Roska, MD, PhD, who is also a founding director of the Institute of Molecular and Clinical Ophthalmology Basel (IOB).

“This programme exemplifies a key goal of IOB: combining our deep understanding of retinal biology and vision with breakthrough technologies to develop novel therapies for vision loss,” Dr Roska said.

Other researchers involved in development and testing of the therapy said they look forward to the next steps in the programme. Bence Gyorgy, a group leader at the IOB and RhyGaze scientific co-founder, said, “We are excited to see this programme moving forward because it uniquely presents the opportunity to restore high-resolution vision in blind patients.”

Katherine High, CEO of RhyGaze, sees collaboration with IOB as a valuable opportunity to reach the goals of the therapy. She said, “I look forward to partnering with colleagues at IOB to bring this novel gene therapy to patients, and I am excited about the team we are assembling to pursue this important goal. RhyGaze will determine over the next few years whether the compelling data generated at IOB can translate to clinical outcomes. If that is true, this innovation will have a worldwide impact in improved therapeutics for blindness.”

Institute of Molecular and Clinical Ophthalmology Basel Spinout RhyGaze Closes USD 86 Million Series A Round to Further Novel Gene Therapy for Vision Restoration. Businesswire. Accessed January 13, 2025. 

Institute of Molecular and Clinical Ophthalmology Basel Spinout RhyGaze Closes USD 86 Million Series A Round to Further Novel Gene Therapy for Vision Restoration | Business Wire

Overview of Novel Treatments for Retinal Vascular Diseases

Video content above is prompted by the following: 


Could you briefly provide an overview of the new treatments available for retinal vascular diseases?

A panelist discusses novel treatments for retinal vascular diseases, including faricimab, aflibercept, and port delivery system with ranibizumab.

Advantages of the Molecular Structure of Aflibercept

Aflibercept 2 mg is considered the standard of care for retinal vascular diseases. Can you briefly explain the structure of the aflibercept molecule and its significance?

Panelists discuss how aflibercept’s molecular structure contributes to its clinical efficacy as a standard treatment for retinal vascular diseases.

Grace Koennecke

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