Aflibercept 2 mg Biosimilar (aflibercept-ayyh, Pavblu): Experience of safety in clinical settings-APEX- safety study

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Authors and Affiliations

1. Lotus Eye Hospital and Institute, Avinashi Road, Coimbatore, TN, India

   Ashish Sharma

2. Sierra Eye Associates, Reno, NV, USA

   Arshad M. Khanani & Humza Sulahria

3. The University of Nevada Reno School of Medicine, Reno, NV, USA

   Arshad M. Khanani & Humza Sulahria

4. Retina Vitreous Associates of Florida, Tampa, Florida, USA

   David Eichenbaum & Allyza Flores

5. Retina-Vitreous Associates Medical Group, Los Angeles, California, USA

   David Boyer

6. The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, PA, USA

   Alexander Shaer, Trisha Ortiz & Carl Regillo

7. Gavin Herbert Eye Institute, University of California Irvine, Irvine, CA, USA

   Baruch D. Kuppermann

8. Division of Ophthalmology, Tel Aviv Sourasky Medical Center Tel Aviv University, Tel Aviv, Israel

   Anat Loewenstein

9. Department of Ophthalmology, Scientific Institute San Raffaele University Vita-Salute, Milano, Italy

   Francesco Bandello

10. Department of Surgical, Medical, Dental and Morphological Sciences, University of Modena and Reggio Emilia (UNIMORE), Modena, Italy

    Giuseppe Querques

11. Ophthalmology Unit – Policlinic of Modena, Modena, Italy

    Giuseppe Querques

12. Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan

    Tomoko Ueda-Consolvo, Masaaki Ishida, Tomoko Nakamura & Atsushi Hayashi

13. Department of Ophthalmology, Aichi Medical University, Nagakute, Aichi, Japan

    Kotaro Tsuboi

14. Madhavi Netralaya Ara Bihar, Bihar, India

    Nilesh Kumar

15. Aster Hospital, Dubai, UAE

    Nikulaa Parachuri

16. Department of Retina Services Shantilal Shanghvi Eye Institute (SSEI), Mumbai, India

    Jay Sheth

17. Trilochan Netralaya Sambalpur, Odisha, India

    Chitaranjan Mishra

18. Department of Vitreoretinal Services Disha Eye Hospitals, Kolkata, West Bengal, India

    Debdulal Chakraborty

19. Banker’s Retina Clinic and Laser Centre, Ahmedabad, India

    Alay Banker

20. Illinois Retina Associates, Chicago, IL, USA

    Kourous A. Rezaei

21. Cole Eye Institute Cleveland Clinic Foundation, Cleveland, OH, USA

    Peter K. Kaiser

22. Department of Ophthalmology University of Bonn, Bonn, Germany

    Frank G. Holz

23. NIHR Moorfields Biomedical Research Centre Moorfields Eye Hospital and UCL, London, UK

    Sobha Sivaprasad

24. Ophthalmology Department, Gazi University School of Medicine Besevler, Ankara, Turkey

    Şengül Özdek

25. Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, 69004, Lyon, France

    Kodjikian Laurent

26. UMR5510MATEIS, CNRS, INSA Lyon Université de Lyon, 169100, Villeurbanne, France

    Kodjikian Laurent

27. Augen Zentrum Gutenberg AG, Bern, Switzerland

    Alper Bilgic

28. Department of Ophthalmology University of Udine, Udine, Italy

    Paolo Lanzetta & Valentina Sarao

29. Tufts University School of Medicine New England Eye Center, Boston, MA, USA

    Caroline Baumal

30. Roche Pharmaceuticals, Basel, Switzerland

    Nancy Holekamp

31. Department of Ophthalmology, Kagoshima University, Kagoshima, Japan

    Taiji Sakamoto

32. Moorfields Eye Hospital NHS FT, London, UK

    Adnan Tufail & Luke Nicholson

33. Department of Ophthalmology, Bascom Palmer Eye Institute, Miami, Florida, USA

    Nicolas Yannuzzi & Jayanth Sridhar

34. Doheny Eye Institute, Pasadena, CA, USA

    Giulia Corradetti

35. Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA

    Aleksandra Rachitskaya

36. Centre for Public Health, Queen’s University Belfast, Belfast, UK

    Tunde Peto

37. Department of Ophthalmology, University Hospital Bonn, Venusberg Campus 1, 53127, Bonn, Germany

    Maximilian W. M. Wintergerst

38. Istituto Clinico S. Anna, Via del Franzone, 31, 25127, Brescia, Brescia, Italy

    Barbara Parolini

39. Byers Eye Institute, Stanford University, Palo Alto, California, USA

    Quan Dong Nguyen & Diana V. Do

40. NIHR Biomedical Research Centre at Moorfields, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK

    Pearse A. Keane

41. Associated Retinal Consultants PC, Royal Oak, MI, USA

    Tarek Hassan

42. Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA

    Tarek Hassan

43. Department of Ophthalmology, Duke University School of Medicine, Durham, North Carolina, USA

    Dilraj S. Grewal

44. University of Otago, Dunedin New Zealand & University of Girona, Girona, Spain

    Francesc March

45. Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistr. 52, 20246, Hamburg, Deutschland

    Martin S. Spitzer

46. Tehran Medical Sciences, Islamic Azad University, Tehran, Iran

    Khalil G. Falavarjani

47. Department for BioMedical Research, University of Bern, Murtenstrasse 24, CH-3008, Bern, Switzerland

    Martin S. Zinkernagel

48. Department of Ophthalmology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 15, CH-3010, Bern, Switzerland

    Martin S. Zinkernagel

49. Department of Ophthalmology, Institute of Vision Research, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea

    Christopher Seungkyu Lee

50. University of Texas Southwestern Medical Center, Dallas, TX, USA

    Judy E. Kim

51. Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea

    Se Joon Woo

52. Royal Eye Unit, Kingston Hospital NHSFT, London, UK

    Clara Vazquez-Alfageme

53. Wakabayashi Eye Clinic, Nonoichi, Ishikawa, Japan

    Taku Wakabayashi

Consortia

Contributions

AS, AMK, DE, DB, AS, TO, HS, AF, CR: conception, analysis, drafting, integrity check, final approval.

Corresponding author

Correspondence to Ashish Sharma.

Competing interests

Ashish Sharma: Consultant for Oculis, Novartis, Allergan, Bayer, Lupin, Intas, Ajanta and Sun Pharma Speaker fee MS Pharma, Abdi İbrahim İlaç San. ve Tic, Samil Pharma, Roche. Arshad M Khanani: Consultant: Abbvie, ADARx Pharmaceuticals, Adverum, Alcon, Alkeus, Allgenesis, Amgen, Annexin, Annexon, Apellis Pharmaceuticals, Ashvattha, Therapeutics, Astellas, Aviceda Therapeutics, Beacon Therapeutics, Boehringer Ingelheim, Clearside Biomedical, Complement Therapeutics, 4DMT, Entarada, Exegenesis, EyePoint Pharmaceuticals, Fronterra Therapeutics, Genentech, Harrow, i-Lumen Scientific, InFocus, Iveric Bio, Janssen Pharmaceuticals, Kriya Therapeutics, Kyowa Kirin, Lexitas, Merit, Neurotech, Nanoscope, Novartis, Ocugen, Ocular Therapeutix, Oculis, Ollin, Opthea, Opus Genetics, Perfuse, Recens Medical, Regeneron Pharmaceuticals, Regenxbio, Revive, RevOpsis, Roche, Samsung, Sanofi, Stealth BioTherapeutics, Sun Pharma, Surrozen, Thea Pharma, Therini, Unity Biotechnology, Vanotech, Vial, ZipBio. Research support: Aviceda, Adverum, Alexion, Annexon, Astellas, Aviceda Therapeutics, Biojiva Complement Therapeutics, 4DMT, Eyepoint Pharmaceuticals, Exegenesis, Genentech, Gyroscope Therapeutics, Iveric Bio, Janssen, Kyowa Kirin, Ocular, Ollin, Therapeutix, Regenxbio, Roche, Sanofi, Vanotech. Stock options: Ashvattha, Aviceda Therapeutics, Oculis, Ollin, PolyPhotonix, Recens Medical, Perfuse, RevOpsis, Vial, ZipBio. Board of Directors: Oculis. David Eichenbaum: Consultant: Alimera, Allergan, Apellis, Bausch + Lomb, Dutch Ophthalmic, EyePoint, Genentech, Inc., Gyroscope, Iveric Bio, KKR, Kodiak, Novartis, Recens Medical, Regeneron, Regenxbio, Vial; Equity/Stockholder: Boston Image Reading Center, Clearside, Hemera, Network Eye, US Retina; Founder: Network Eye; Investigator: Alkahest, Annexon, AsclepiX, Bayer, Chengdu, EyePoint, Gemini, Genentech, Inc., Gyroscope, Ionis, Iveric Bio, Kodiak, Mylan, NGM, Novartis, Ocular Therapeutix, Ophthea, RecensMedical, Regeneron, Regenxbio, Unity; Speaker: Allergan, Apellis, Bayer, Dutch Ophthalmic, EyePoint, Genentech, Inc., Novartis. David Boyer: David Boyer, MD, has disclosed that he has received grants for clinical research and educational activities from Novartis, Alcon, Genentech, Pfizer/OSI, and Allergan. Dr. Boyer has also disclosed that he has served as an advisor or consultant to Novartis, Alcon, Genentech, Pfizer/OSI, and Allergan. Alexander Shaer: None. Trisha Ortiz: None. Humza Sulahria: None. Allyza Flores: None. Carl Regillo: Consultant: 4DMT, Adverum, Allergan, Annexon, Apellis, Astellas, Aviceda, Bausch and Lomb, Chengdu Kanghong, Cognition, EyePoint, Genentech, Janssen, Kodiak, Lineage, Kyoto Drug Development, Merck, NGM, Novartis, Ocugen, Ocuterra, Opus Genetics, Opthea, Ray, RegenXBio, Stealth, Thea, Zeiss, ZipBio; Research grant support: 4DMT, Adverum, Allergan, Annexon, Apellis, Astellas, EyePoint, Genentech, Gyroscope, Iveric, Janssen, Kodiak, Lineage, NGM, Notal, Novartis, Ocugen, Ocuterra, Opthea, Regeneron, RegenXBio.