Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

NCT04522167 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FYB203-03-01
• Study Type: interventional
• Target: 434
• Locations: 9 countries
• Sites: 66

Brief Summary

This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline.

  Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.

  Week 8

Secondary Outcomes (8)

• Evaluate and Compare Functional Changes of the Retina by BCVA Over Time

  Through study completion, until Week 56 (Visit 9)

• Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness

  Through study completion, until Week 56 (Visit 9)

• Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline

  Through study completion, until Week 56 (Week 9)

• Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time

  Through study completion, until Week 56 (Visit 9)

• Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)

  At Baseline and Visit 3a (48 hours after the 3rd dose)

Study Arms (2)

FYB203 (Proposed aflibercept biosimilar)

EXPERIMENTAL

Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.

Drug: FYB203 (Proposed aflibercept biosimilar)

Eylea® (Aflibercept)

ACTIVE COMPARATOR

Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.

Drug: Eylea® (Aflibercept)

Interventions

FYB203 (Proposed aflibercept biosimilar) DRUG

Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.

FYB203 (Proposed aflibercept biosimilar)

Eylea® (Aflibercept) DRUG

Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.

Eylea® (Aflibercept)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years at Screening.
• Male or female:
• Male: A male patient must agree to use contraception as defined in this protocol during the treatment period and for at least 4 weeks after the last dose of study treatment.
• Female: A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP), OR
• A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Willingness and ability to undertake all scheduled visits and assessments.
• Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD

You may not qualify if:

• Patients are not eligible for the study if any of the following criteria apply:
• Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
• Study eye requiring immediate treatment.
• Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye.
• Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure \[IOP\] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication).
• Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA.
• Any concurrent intraocular condition in the SE (e.g. glaucoma, cataract, or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
• Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer.
• Any type of advanced, severe, or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
• Stroke or myocardial infarction within 6 months prior to randomization.
• Known hypersensitivity to the IMP (aflibercept or any component of the aflibercept formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.

Sponsors & Collaborators

• Bioeq GmbH: lead

Study Sites (66)

Research Site

Sofia, Bulgaria

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Stara Zagora, Bulgaria

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Hradec Králové, Czechia

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Ostrava, Czechia

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Pardubice, Czechia

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Prague, Czechia

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Sokolov, Czechia

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Budapest, Hungary

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Debrecen, Hungary

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Pécs, Hungary

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Szeged, Hungary

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Székesfehérvár, Hungary

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Tatabánya, Hungary

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Zalaegerszeg, Hungary

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Haifa, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Rehovot, Israel

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Rishon LeZiyyon, Israel

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Tel Aviv, Israel

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Bologna, Italy

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Florence, Italy

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Milan, Italy

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Roma, Italy

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Rozzano, Italy

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Udine, Italy

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Akita, Japan

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Amagasaki, Japan

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Asahikawa, Japan

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Chiyoda City, Japan

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Chūō, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Hamamatsu, Japan

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Himeji, Japan

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Hirakata, Japan

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Kita-ku, Japan

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Kurume, Japan

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Meguro City, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Sapporo, Japan

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Shinjuku-Ku, Japan

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Suita, Japan

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Toride, Japan

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Yokosuka, Japan

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Bielsko-Biala, Poland

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Bydgoszcz, Poland

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Krakow, Poland

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Lodz, Poland

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Olsztyn, Poland

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Tarnów, Poland

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Warsaw, Poland

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Chelyabinsk, Russia

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Kazan', Russia

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Moscow, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Kharkiv, Ukraine

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Kherson, Ukraine

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Kropyvnytskyi, Ukraine

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Lutsk, Ukraine

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Odesa, Ukraine

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Poltava, Ukraine

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Zaporizhzhya, Ukraine

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Related Publications (1)

• Balser S, Capsius B, Hole R, Papp A, Preissinger N, Rozenknop A, Tiko T. Randomised, double-masked trial to compare the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration. BMJ Open Ophthalmol. 2026 Jan 5;11(1):e002398. doi: 10.1136/bmjophth-2025-002398.

  PMID: 41494750 DERIVED

MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Public Register Contact
• Organization: Formycon AG

clinicaltrials@formycon.com

+49 89 864667 100

Study Officials

• Study Official

  Bioeq GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 21, 2020
• Study Start: July 21, 2020
• Primary Completion: June 23, 2022
• Study Completion: May 18, 2023
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HU (7); CZ (5); RU (5); UA (7); JP (20); PL (7); BU (2); IL (7); IT (6)