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H2R

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Alias Born 07/17/2014

H2R

Re: None

Sunday, 05/14/2023 1:44:49 PM

Sunday, May 14, 2023 1:44:49 PM

Post# of 862
Particulate Matter & Ophthalmic Standards

I don't remember seeing this slide before. Another strong point for OTLK's approval.

1. High standards
2. Monoclonal Antibody Shearing/Fragmentation During the Repackaging Process (Slide 11)
3. "Extended storage of the drug in the syringe can potentially increase the chance of particle formation, especially in silicone-based systems. Unwanted particles in the solution can cause irritation in the eye and potentially react with the active drug to lower efficacy.¹" (slide 12)
4. "Storage of a protein solution in a plastic syringe can extract leachable material from the syringe barrel and rubber plunger tip. Compounds can induce protein aggregation and potentiate adverse effects in patients such as immunogenicity. Therefore, properly developed therapeutic proteins are not stored in plastic containers." (Slide 13)



Their April presentation has additional info.
https://ir.outlooktherapeutics.com/static-files/e2080eef-8a6b-438b-8447-bf12984db904

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