Effective and safe handling of pre-filled syringe (PFS) for administration of biosimilar candidate AVT06 (aflibercept) in patients with chorioretinal vascular diseases

Published on 10 November 2025

Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(3).

DOI: 10.5639/gabij.2025.1403.
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Introduction: Chorioretinal vascular diseases are among the leading causes of irreversible blindness in industrialized countries. The prognosis of chorioretinal vascular diseases has been largely improved with the introduction of the vascular endothelial growth factor (VEGF) inhibitors, biological drugs which have become the first line therapy for patients with these conditions. The development of biosimilars may improve access to such biological medicinal products while reducing the healthcare costs. 
Study Objectives: This study aimed to demonstrate effective and safe handling of AVT06 pre-filled syringe (PFS) administered to study participants with chorioretinal vascular diseases. The primary objective was to evaluate the proportion of successful administrations of AVT06 after a single administration with PFS. The secondary objective of the study was to evaluate ocular safety after a single dose of AVT06 delivered with PFS. 
Results: The proportion of successful injections after a single administration of AVT06 PFS was 100%, demonstrating the intended and safe handling by the physicians. The AVT06 administered with PFS was found to be safe and well-tolerated in participants with chorioretinal vascular disease without any clinically significant safety findings related to the study treatment. No serious adverse events (SAEs) or adverse events (AEs) leading to discontinuation were reported, as well as no treatment-related treatment emergent AEs. Two participants were reported with adverse events of special interest (AESIs) up to end of study, neither of them was related to the study treatment. 
Discussion and Conclusion: This study demonstrated intended and safe handling of AVT06 PFS by the intended users. The intravitreal injection of AVT06 administered with PFS was safe and well tolerated during the treatment of chorioretinal vascular disease.

Introduction

Chorioretinal vascular diseases are among the leading causes of irreversible blindness in industrialized countries [1]. These conditions include age-related macular degeneration (AMD), diabetic macular oedema (DME), retinal vein occlusion (RVO), diabetic retinopathy (DR), or myopic choroidal neovascularization (CNV). 

AMD is a multifactorial disease that is classified into two types, of which neovascular AMD (nAMD) can lead to the most severe vision loss. In central RVO and branch RVO, retinal ischaemia occurs and signals the release of vascular endothelial growth factor (VEGF), which in turn destabilizes the tight junctions and promotes endothelial cell proliferation. DME is a consequence of diabetic retinopathy (DR), and it is characterized by increased vascopermeability and impairment of the retinal capillaries, which may result in loss of visual acuity. Myopic CNV develops as a wound healing mechanism consequent to Bruch’s membrane ruptures and represents the most vision-threatening event in pathologic myopia [2, 3]. The prognosis of chorioretinal vascular diseases has been largely improved with the introduction of the VEGF inhibitors, biological drugs which have become the first-line therapy for patients with these conditions. In particular, the development of biosimilars may improve access to such biological medicines and reduce healthcare costs. 

Aflibercept (ATC S01LA05) is a recombinant Fc fusion protein created by fusing the second immunoglobulin (Ig) domain of human vascular endothelial growth factor receptor (VEGFR)-1 with the third Ig domain of human VEGFR-2, which is in turn fused to the constant region of human IgG1. Eylea© (aflibercept) is a globally approved anti-VEGF for various ophthalmic indications for intravitreal (IVT) administration. Alvotech developed AVT06 as a biosimilar to Eylea©, targeting the same indications as the reference product according to the principles and recommendations outlined in the global biosimilar guidelines [4-6]. 

While biosimilar versions of several reference product anti-VEGF agents have been approved or are in late-stage development, none have yet launched with a pre-filled syringe (PFS) presentation [7]. Intravitreal injection with the use of PFS provides several advantages for both retinal users and patients, such as the reduced preparation and injection time, reduced risk of ocular infections and inflammations, and major precision in the administration of the correct drug volume [7]. To benefit from the advantages offered by the PFS, in addition to the single-use vial, Alvotech also developed AVT06 in PFS presentation, see Figure 1. Both AVT06 vial and PFS deliver a dose of 2 mg AVT06 in 50 μL (40 mg/mL). 

Figure 1: AVT06 pre-filled syringe

Study Objectives

The clinical trial reported in this article aimed to demonstrate intended and safe handling of AVT06 PFS, by evaluating the proportion of successful injections of AVT06 after a single administration with PFS. The secondary objective of the study was to evaluate ocular safety after a single dose of AVT06 delivered with PFS. The Optional Extension Phase provided the participants with continuous treatment with AVT06 to collect additional long-term safety data of the AVT06 delivered from the PFS. This study was conducted to support licensing of AVT06 PFS presentation and was part of a submission to regulatory authorities, together with a confirmatory efficacy and safety study demonstrating comparative efficacy and safety between AVT06 in vial presentation and Eylea© in patients with nAMD [8]. 

Methods

Study design and study population 

Overall, 35 male and female participants were planned to be enrolled in this single arm, open label study. The study started with a Screening period of two weeks (14 days), after which eligible participants entered the Active Phase and received AVT06 PFS on Day 1 (Baseline), which was followed by 4 weeks of observation. Screening and Day 1/ Baseline visit could have occurred on the same day. Participants could then enter an Optional Extension Phase, up to Week 52, according to the dosing regimen for the respective indications: 

  • Wet AMD 
  • Diabetic macular edema (DME) 
  • Retinal vein occlusion (RVO) 
  • Diabetic retinopathy (DR) 
  • Myopic CNV

Only 1 eye was selected as the study eye based on the inclusion and exclusion criteria. A schematic representation of the study design is reported in Figure 2.

Figure 2: Schematic study design

The study was conducted at seven study centres in two countries: three investigational sites in Latvia and 4 investigational sites in Georgia. At each investigational site, one physician was assigned to administer AVT06 PFS to all the study participants at that centre.

The study population was selected based on a set of inclusion and exclusion criteria, to ensure they met the characteristic of the research scope. The key criteria are reported below: 

Inclusion criteria

  1. Male or female ≥18 years old. 
  2. Participants diagnosed with nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye, treatment naïve or already under the aflibercept treatment or its marketed biosimilar. 
  3. Study eye, eligible for the treatment of aflibercept, was selected by the Principal Investigator. 
  4. Participants were able to follow contraception requirements for the entire duration of the study.

Exclusion criteria

  1. Any evidence of active infection and/or intraocular inflammation or history of intraocular inflammation after past IVT injections in either eye. 
  2. Uncontrolled ocular hypertension (defined as IOP (intraocular pressure) ≥25 mmHg despite treatment with most antiglaucoma treatment tolerable) at Screening and Baseline visits in either eye. 
  3. Participants with best-corrected visual acuity (BCVA) of <20/200 (<34 letters) as assessed by early treatment diabetic retinopathy study (ETDRS) letter score in both eyes at Screening and Baseline visits.  
  4. Treatment with any IVT injection in the study eye within 28 days prior to Baseline. 
  5. Any intraocular surgery in the study eye during the past three months prior Baseline and any previous therapeutic radiation in the study eye. 
  6. Any macular hole, presence or history of retinal detachment, retinal pigment epithelial tear, and probably neovascular glaucoma in either eye. 
  7. Previously treated with AVT06 and/or any other anti-VEGF treatment (administered either on the study eye or fellow eye and/or systemic) with the exception of aflibercept or its marketed biosimilar. 
  8. Current systemic infectious disease or a therapy for active infectious disease. 
  9. History of hypersensitivity or anaphylaxis to study treatments (including any excipient) or to any other compound used for the study procedures.
  10. Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever was longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrolment in any other clinical study involving an investigational study treatment. 
  11. History of uncontrolled cardiovascular disease including hypertension, heart failure, or clinically significant electrocardiogram (ECG) abnormality, including participants with QT interval corrected using Fridericia’s formula >480 ms at Screening, confirmed by repeat assessment. 
  12. Any condition that, in the Principal Investigator’s opinion, could have interfered with full participation in the study 

The complete list of the inclusion and exclusion criteria is reported in the Supplementary Information. 

Handling of AVT06 pre-filled syringe 

The study aimed to evaluate the handling and safety of the AVT06 PFS in participants with chorioretinal vascular disease (nAMD, DME, RVO, DR, or myopic CNV) to support licensure of AVT06 PFS presentation. An independent observer was responsible for assessing the successful administration of AVT06 PFS injection conducted by the Principal Investigator (PI) or designee (qualified study physician designated by the PI) at Day 1. A ‘Successful’ attempt had to have all the following: 

  • PI or designee, qualified study physician designated by the PI, has performed all steps required to prepare the PFS including accurate positioning of the plunger with dosing line to set the dose using aseptic technique. 
  • PI or designee, qualified study physician designated by the PI, administered the correct dose into the injection site using aseptic technique. 
  • These steps were observed during injection procedure under aseptic technique and documented by the independent observer. 

The independent observer was a qualified physician experienced in administering IVT injections. During IVT injection process, if PI or designee was not following any of the preparation and/or administration steps, then the independent observer was required to intervene immediately to correct the steps before injection into the study eye, and this attempt would have been reported as ‘Unsuccessful’. The independent observer could have been part of the study team. 

Safety assessments 

The ocular safety of AVT06 administered with PFS was evaluated during the Active and Optional Extension Phase. Adverse Events (AEs) were reported by the participant, and the PI or designee were responsible for detecting, documenting, and recording the events that met the definition of AE or Serious AE (SAEs). PI or designee were also responsible for following up all AEs that were serious, considered related to the study treatment or study procedures, or that caused the subject to discontinue the study treatment and study.

The following AEs in the study eye were classified as adverse events of special interest (AESIs) in this study: 

Ocular events

  • Endophthalmitis.
  • Intraocular inflammation.
  • Retinal pigment epithelial tears.
  • Retinal tear/detachment.
  • Cataract (especially of traumatic origin).
  • Hypersensitivity.
  • Retinal haemorrhage.
  • Increase in more than 5 mmHg compared to Baseline resistant to treatment, except the transient IOP rise observed within an hour after injection of study treatment. Elevated IOP resistant to treatment is defined as: no reduction of IOP after combining 3 drugs at a top dosage, within 24 hours.
  • Any case of IOP ≥35 mmHg, at any time, that required treatment.
  • Blindness and significant loss of BCVA as defined with loss ≥20 ETDRS letters from one visit to another.

Non-ocular events

  • Arterial thromboembolic events including non-fatal myocardial infarction and stroke.
  • Cardiovascular ischaemic events.
  • Venous thromboembolic events.
  • New onset of hypertension or worsening of pre-existing con-trolled hypertension.
  • Non-ocular haemorrhage.

Results

Disposition of participants and demographics 

Overall, 44 participants were screened for the study, of whom 9 (20.5%) were screen failures and the remaining 35 (79.5%) were eligible and enrolled in the study. All 35 enrolled participants received the study treatment on Day 1 and completed both the Active Phase and the Optional Extension Phase.

Of the 35 participants, 21 (60.0%) were female and 14 (40.0%) were male, and all were White and not Hispanico or Latino. Most female participants were not of child-bearing potential as they were post-menopausal (19 participants [90.5%]). The mean standard deviation (SD) age of the participants was 68.9 (8.53) years. 

The proportion between right or left eye selected as the study eye was well balanced (right eye: 17 participants [48.6%] vs left eye: 18 participants [51.4%]). The most frequently reported participant disease type at Baseline (Day 1) was nAMD (26 participants [74.3%]) and the overall mean (SD) time since diagnosis for the participant disease type was 111 (136.86) days. The median values for IOP, BCVA, and CST in the study eye at Baseline were 16.1 mmHg, 64 letters, and 352 microns, respectively. Out of 35 participants enrolled, 31 (88.6%) were treatment naïve participants, while 4 (11.4%) participants had been already on treatment with Eylea©. Participants demographics and Baseline characteristics are shown in Table 1. 

Table 1: Summary of demographics and baseline characteristics [a, b, c]

Handling of AVT06 pre-filled syringe 

The handling of the AVT06 PFS was assessed by reporting the proportion of AVT06 injections successfully administered with PFS at Baseline (Day 1) by the qualified physician. 

All the preparation and administration steps were observed during the injection procedure on Day 1 and were assessed as successful by the independent observer in all 35 participants, as reported in Table 2. 

Table 2: Proportion of AVT06 injections successfully administered with PFS on Day 1

Safety evaluation 

A total of 21 participants (60%) experienced at least 1 AE, which were all treatment emergent adverse events (TEAEs) up to Week 52 (during the study), and none of the TEAEs were related to the study treatment. At least 1 ocular TEAEs was reported for 7 participants (20%), either in the study eye or in the fellow eye, while 16 participants (45.7%) were reported with at least 1 non-ocular TEAE. The majority of the ocular TEAEs were reported as eye disorders (7 events reported by 6 participants [17.1%]), of which the most common was neovascular age-related macular degeneration (2 events reported by 2 participants [5.7%]). 12 infections as infestation were reported by 10 participants as non-ocular TEAEs (28.6%), with the most common as symptomatic bacteriuria (5 events reported by 5 participants [14.3%]) and nasopharyngitis (4 events reported by 4 participants [11.4%]). The incidence of ocular and non-ocular TEAEs is reported in Table 3.

Table 3: Incidence of treatment-emergent adverse events (TEAEs) up to Week 52

No severe TEAEs were reported for any of the participants, moderate and mild severity TEAEs were reported for 7 participants (20%) and 14 participants (40%), respectively. 

No SAEs were reported in the study up to Week 52. 

As shown in Table 4, two participants (5.7%) were reported with adverse events of special interest (AESIs) up to Week 52. One participant had an ocular AESI of visual acuity reduced and the other participant had a non-ocular AESI of essential hypertension, neither of them were related to the study treatment.

Table 4: Incidence of adverse events of special interest up to Week 52

Discussion

This study evaluated the handling and safety of AVT06 PFS, a delivery system developed to administer AVT06, in participants with chorioretinal vascular diseases. The proportion of injections successfully performed by qualified physicians was assessed on Day 1 (Baseline), and the safety was assessed throughout the study, up to Week 52. Most of the clinical trials using biosimilar with PFS focus on comparative efficacy and safety with the originator, with limited direct evaluation of user experience. This is one of the few clinical trials evaluating the usability of the PFS biosimilars of anti-VEGF as the primary endpoint. The design of these studies (Sandoz, NCT05161806; Samsung, NCT06176963) are similar to that presented in this article. 

The proportion of successful injections after a single administration of AVT06 PFS was 100%, demonstrating the intended and safe handling by the retinal physicians. All the preparation and administration steps were observed during injection procedure under aseptic technique and assessed as “Successful” attempts by the independent observer. 

The treatment of chorioretinal vascular disease with AVT06 PFS was well tolerated by the study participants during the entire course of the study (up to Week 52), without any clinically significant safety findings related to the study treatment. The absence of SAE and severe or treatment-related TEAEs is in line with the safety profile of Eylea© and supported the demonstration of safety of AVT06 in different indications.

The design of this clinical trial was based on scientific advice from the US Food and Drug Administration. As most controlled clinical trials, the findings of this study are limited by the single administration of AVT06 PFS and by the small sample size, which may not adequately capture the variability across a broader population. However, it provides encouraging evidence of effective handling and safety of the PFS, which is expected to represent a convenient option for intravitreal injections. 

Conclusion

AVT06 in vials and PFS has recently received the EMA approval to be marketed as a biosimilar to Eylea© (aflibercept). The approval of this biosimilar could contribute to the timely access to effective therapy, which is essential for patients affected by retinal diseases. The availability of PFS could contribute to the growing improvement of the treatment of chorioretinal vascular diseases for both physicians and patients, due to the manageable handling of the device and the safety response following the administration.

Acknowledgement

The authors thank the participants who volunteered in the study and the investigators who contributed. The authors also thank Saphalya Padmanabhan for the data management activities and Caroline Pelckmans for the biostatistics support. Lastly, the authors thank Dr Lorna Rettig for the medical writing assistance. 

Funding sources

This study was funded by Alvotech Swiss AG. 

Author Contributions

Silvia Cirillo, Riken Soni, Masna Rai, Steffen Leutz, Eveline Schurink and Fausto Berti were involved in the conception and the design of the study. Silvia Cirillo and Riken Soni were involved in the provision of study material and acquisition of the data. Riken Soni, Masna Rai, Steffen Leutz, Eveline Schurink and Fausto Berti did the analysis and/or the interpretation of the data. All authors revised the report critically. All authors approved the final version.

Ethics approval

The study was conducted in accordance with the protocol, the consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP), European Union Clinical Trials Regulation (EU-CTR) No 536/2014, and European Union–Good Manufacturing Practice and other Guidelines, and applicable laws and regulations including EU-CTR 536/2014 for clinical studies. 

Consent to participate

All participants gave written informed consent to participate in the study prior to undertaking any study-related examination or activity. The informed consent document was approved by each study site’s institutional review board or independent ethics committee.

Competing interests: All authors of this manuscript are employees at Alvotech. 

Provenance and peer review: Not commissioned; externally peer reviewed. 

Authors

Silvia Cirillo, PhD
Riken Soni, MPharm 
Masna Rai, PhD
Steffen Leutz, PhD 
Eveline Schurink, MD 
Fausto Berti, PharmD, PhD 

Alvotech Swiss AG, Thurgauerstrasse 54, CH-8050 Zürich, Switzerland 

References
1. Quartilho A, Simkiss P, Zekite A, Xing W, Wormald R, Bunce C. Leading causes of certifiable visual loss in England and Wales during the year ending 31 March 2013. Eye (Lond). 2016;30(4):602-7. doi:10.1038/eye.2015.288 
2. European Medicines Agency. Eylea® (aflibercept) [SmPC] [homepage on the Internet]. [cited 2025 Oct 14]. Available from: https://www.ema.europa.eu/ en/documents/product-information/eylea-epar-product-information_en.pdf 
3. US Food and Drug Administration. Eylea® (aflibercept) [USPI]. [homepage on the Internet]. [cited 2025 Oct 14]. Available from: https://www.accessdata.fda. gov/drugsatfda_docs/label/2011/125387lbl.pdf 
4. European Medicines Agency. Guideline on similar biological medicinal products (revision 1). 10 April 2024 [homepage on the Internet]. [cited 2025 Oct 14]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ guideline-similar-biological-medicinal-products-rev1_en.pdf 
5. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues (revision 1). 22 May 2014 [homepage on the Internet]. [cited 2025 Oct 14]. Available from: http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2014/06/WC500167838.pdf 
6. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for Industry. Apr 2015 [homepage on the Internet]. [cited 2025 Oct 14]. Available from: https://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM291128.pdf 
7. Sharma A, Loewenstein A, Parachuri N, Kumar N, Rasal A, Bandello F, et al. Biosimilar anti-VEGF- is prefilled syringe (PFS) a challenge? Eye (Lond). 2024;38(2):244-5. 
8. Agostini H, Baumane K, Balčiūnienė VJ, Ozols K, Soni R, Hamdi S, et al. A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opin Biol Ther. 2025;25(7):773-87. doi: 10.1080/14712598.2025.2519531. 

Supplementary Information

Inclusion and exclusion criteria
Inclusion criteria
Subjects are eligible to be included in the study only if all of the following criteria apply:

  1. Male or female ≥18 years old.
  2. Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye, treatment naïve or already under the aflibercept treatment or its marketed biosimilar.
  3. Study eye, eligible for the treatment of aflibercept, will be selected by the Principal Investigator.
  4. Subject or his/her legal representative, must be able to read, understand and sign an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures.
  5. Willing and able to comply with all study procedures and be likely to complete the study.
  6. Subjects must be able to follow the contraception requirements.
  7. A male subject must agree to use contraception during the treatment period and for at least 3 months after the last Intravitreal(ly) (IVT) injection of study treatment and refrain from donating sperm during this period.

A female subject is eligible to participate if she is not pregnant, not breastfeeding, not intending to become pregnant during the treatment period and for at least 3 months after the last IVT injection of study treatment, and refrains to donate eggs (ova, oocytes) or freeze/store eggs for the purpose of reproduction during this period. The subject should meet at least 1 of the following conditions:

  • 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 3 months after the last IVT injection of study treatment. 

Exclusion criteria
Subjects are excluded from the study if any of the following criteria apply: 

Ocular:

  1. Evidence of active infections such as but not limited to blepharitis, keratitis, or conjunctivitis in either eye.
  2. Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past IVT injections with any agent in either eye.
  3. History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye.
  4. Uncontrolled ocular hypertension (defined as IOP ≥25 mmHg despite treatment with most antiglaucoma treatment tolerable) at Screening and Baseline visits in either eye.
  5. Subjects with best-corrected visual acuity (BCVA) of <20/200 (<34 letters) as assessed by early treatment diabetic retinopathy study (ETDRS) letter score in both eyes at Screening and Baseline visits.
  6. Treatment with any IVT injection in the study eye within 28 days prior to Baseline.
  7. Previous therapeutic radiation in the study eye.
  8. Any intraocular surgery in the study eye at any time during the past 3 months prior to Baseline.
  9. Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational including steroids) in the study eye.
  10. Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety.
  11. Active or suspected ocular or periocular infection, within 2 weeks prior to Baseline in either eye.
  12. Active scleritis or episcleritis or presence of scleromalacia in either eye.
  13. Any macular hole, presence or history of retinal detachment, retinal pigment epithelial tear, and probably neovascular glaucoma in either eye.
  14. Previously treated with AVT06 and/or any other anti-VEGF treatment (administered either on the study eye or fellow eye and/ or systemic) with the exception of aflibercept or its marketed biosimilar.

Other:

  1. Current systemic infectious disease or a therapy for active infectious disease.
  2. History of hypersensitivity or anaphylaxis to study treatments (including any excipient) or to any other compound used for the study procedures.
  3. Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment.
  4. History of uncontrolled cardiovascular disease including hypertension, heart failure, or clinically significant electrocardiogram (ECG) abnormality, including subjects with QT interval corrected using Fridericia’s formula [QTcF] >480 ms at Screening, confirmed by repeat assessment.
  5. Acute coronary event or stroke within 6 months before enrollment.
  6. Any condition that, in the Principal Investigator’s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the subject, or interfere with interpretation of study data.
  7. Malignancy diagnosed within 5 years except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, in situ prostate cancer, or in situ breast ductal carcinoma.
  8. Subjects not suitable for participation, whatever the reason, as judged by the Principal Investigator, including medical or psychiatric conditions, or being institutionalized due to legal or regulatory order, inmate of psychiatric wards or prison or state institutions or subjects potentially at risk of noncompliance to study procedures.
  9. Prior treatment with systemic steroids within 30 days of Screening, with the exception of low stable doses of corticosteroids (defined as 10 mg or lower oral prednisolone or equivalent dose used for 90 days or more prior to Screening). Nasal, dermal, and inhaled steroids are permitted.
  10. Treatment with systemic medications known to be toxic to the lens, retina, or optic nerve including (but not limited to) deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, and ethambutol from the time of Screening.

Author for correspondence: Fausto Berti, PharmD, PhD, Clinical & Medical Affairs, Alvotech Swiss AG, Thurgauerstrasse 54, CH-8050 Zürich, Switzerland    

Disclosure of Conflict of Interest Statement is available upon request.

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