September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Design and Development of ENV515 Intraocular Applicator for Intracameral Injections of ENV515 Glaucoma Extended Release (XR) Therapy
Author Affiliations & Notes
  • Tomas Navratil
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Jessie Delgado
    EG-Gilero, Durham, North Carolina, United States
  • Andres Garcia
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Gretchen Willard
    EG-Gilero, Durham, North Carolina, United States
  • Andrew Corson
    EG-Gilero, Durham, North Carolina, United States
  • Rozemarijn S Verhoeven
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Leo Trevino
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Rhett Schiffman
    Envisia Therapeutics, Research Triangle Park, North Carolina, United States
  • Footnotes
    Commercial Relationships   Tomas Navratil, Envisia Therapeutics (E), Envisia Therapeutics (P), Envisia Therapeutics (I); Jessie Delgado, Envisia Therapeutics (F); Andres Garcia, Envisia Therapeutics (E); Gretchen Willard, Envisia Therapeutics (F); Andrew Corson, Envisia Therapeutics (F); Rozemarijn Verhoeven, Envisia Therapeutics (E); Leo Trevino, Envisia Therapeutics (E); Rhett Schiffman, Envisia Therapeutics (E), Envisia Therapeutics (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3021. doi:
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      Tomas Navratil, Jessie Delgado, Andres Garcia, Gretchen Willard, Andrew Corson, Rozemarijn S Verhoeven, Leo Trevino, Rhett Schiffman; Design and Development of ENV515 Intraocular Applicator for Intracameral Injections of ENV515 Glaucoma Extended Release (XR) Therapy. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3021.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : ENV515 intraocular applicator was designed and manufactured to facilitate safe and effective administration of ENV515 travoprost XR currently in clinical development for glaucoma and to function as a container closure for ENV515. ENV515 travoprost XR experimental therapy is an extended release formulation of travoprost using a biodegradable polymer drug delivery system that is administered via intracameral injection. ENV515 has demonstrated 8 months of IOP lowering in nonclinical studies in dogs and initial 28-day evaluation in Phase 2a clinical study in glaucoma patients indicated a sustained IOP-lowering effect that was comparable to once-daily TRAVATAN Z. The ENV515 injector was designed and is being developed solely for co-distribution with the ENV515 XR therapy for glaucoma, not as a standalone medical device.

Methods : The ENV515 Implant Applicator was designed based on a single-lumen hypodermic needle and molded or machined from medical grade materials. A stainless steel metal shaft actuated via scroll wheel was designed to advance the rod-shaped ENV515 implants from the lumen of the needle. The ENV515 injectors manufactured for the use in ENV515 Phase 2 clinical studies were terminally sterilized and underwent design verification testing.

Results : The gamma sterilized injectors were evaluated for low endotoxin levels (all samples below 0.05 EU/injector); low particulate matter (all samples passed USP specifications); biocompatibility including cytotoxicity, intracutaneous reactivity, irritation and skin sensitization and acute systemic toxicity (all samples passed); and sterility (all samples tested sterile). Needle sharpness was evaluated using artificial membrane injection, ex vivo rabbit cornea force measurements, and injections in intact rabbit eyes with consistently low insertion force. Functional testing for the fully assembled and sterilized implant applicator included pre-loading with a set number of ENV515 implants, actuation of the device, and injection of all preloaded implants (all samples passed).

Conclusions : ENV515 intraocular applicator was designed and manufactured, and the design verification testing was successfully performed. Based on this outcome, ENV515 injector is being used in a 12-month long term evaluation of safety and efficacy of ENV515 travoprost XR across clinical sites in the US.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

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