Investigative Ophthalmology & Visual Science Cover Image for Volume 61, Issue 7
June 2020
Volume 61, Issue 7
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ARVO Annual Meeting Abstract  |   June 2020
Safety evaluation after repeated intravitreal injections of an anti VEGF-A mAb versus ranibizumab in New Zealand white rabbits.
Author Affiliations & Notes
  • Patricia del Carmen del Carmen Muñoz Villegas
    Medical Affairs, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, Mexico
  • Alejandra Sanchez-Rios
    Medical Affairs, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, Mexico
  • Leopoldo Martin Baiza-Durán
    Medical Affairs, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, Mexico
  • Oscar Olvera Montaño
    Medical Affairs, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, Mexico
  • Footnotes
    Commercial Relationships   Patricia del Carmen Muñoz Villegas, Laboratorios Sophia, SA de CV (E); Alejandra Sanchez-Rios, Laboratorios Sophia, SA de CV (E); Leopoldo Baiza-Durán, Laboratorios Sophia, SA de CV (E); Oscar Olvera Montaño, Laboratorios Sophia, SA de CV (E)
  • Footnotes
    Support  This study was sponsored by Laboratorios Sophia, SA de CV (Zapopan, Jalisco, Mexico).
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 313. doi:
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      Patricia del Carmen del Carmen Muñoz Villegas, Alejandra Sanchez-Rios, Leopoldo Martin Baiza-Durán, Oscar Olvera Montaño; Safety evaluation after repeated intravitreal injections of an anti VEGF-A mAb versus ranibizumab in New Zealand white rabbits.. Invest. Ophthalmol. Vis. Sci. 2020;61(7):313.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To inhibit VEGF, many anti-VEGF agents have been developed. PRO-169 is a humanized anti-VEGF-A mAb with a molecular mass of 149 kDa. The purpose of this in vivo preclinical study was to evaluate the long-term safety, after repeated intravitreal (Ivt) injections of PRO-169 versus ranibizumab (Lucentis®, Genentech) in New Zealand white rabbits (NZW).

Methods : A total of 24 male NZW rabbits were injected intravitreally with PRO-169 (n=12), 1.25 mg/0.05ml or ranibizumab (n=12), 0.5 mg/0.05ml into the right eye, whereas the left eye of each rabbit was used as a control. Three consecutive injections were administered at 30-day intervals. Clinical examination included intraocular pressure (IOP), conjunctival hyperemia, edema and flare; before and after injections. Other parameters measured included blood test (blood cytometry, basic metabolic panel and liver function tests) and necropsy (Figure 1). All animal studies were conducted according to the ARVO Statement for the Use of Animals in Ophthalmic and Vision Research.

Results : PRO-169 was shown similar to ranibizumab in maintaining IOP levels after 3 Ivt injections (Figure 2). There was no significant difference in the presence of conjunctival hyperemia 24hrs after the first, second and third intravitreal injections between both groups. Clinical examination found absence of edema and flare at 29, 60 and day 91. The safety of both drugs was similar, since neither presented differences in blood test and post-mortem findings (necropsy).

Conclusions : All the safety variables studied in this preclinical study confirm that the safety profile of both treatments, PRO-169 or ranibizumab, is similar in rabbits after repeated Itv injections.

This is a 2020 ARVO Annual Meeting abstract.

 

 

Figure 2. Comparison of changes in IOP between treatments. PRO-169 (white circle); vs ranibizumab (full square). Data is presented as mean ± SD.

Figure 2. Comparison of changes in IOP between treatments. PRO-169 (white circle); vs ranibizumab (full square). Data is presented as mean ± SD.

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