June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
A Novel, Non-invasive, Self-Administered, Preservative-Free, Sustained Release Product (EySite-TPTM) for Glaucoma Therapy
Author Affiliations & Notes
  • Shikha P Barman
    Executive, Integral BioSystems, Bedford, MA
  • Moli Liu
    Microencapsulations, Integral BioSystems, Bedford, MA
  • Kevin Ward
    Microencapsulations, Integral BioSystems, Bedford, MA
  • Koushik Barman
    Microencapsulations, Integral BioSystems, Bedford, MA
  • Kathryn Crawford
    PharmaOcu, Andover, MA
  • Thomas Leland
    Microencapsulations, Integral BioSystems, Bedford, MA
  • Footnotes
    Commercial Relationships Shikha Barman, Integral BioSystems (F), Integral BioSystems (P); Moli Liu, Integral BioSystems (E), Integral BioSystems (F); Kevin Ward, Integral BioSystems (E), Integral BioSystems (F); Koushik Barman, Integral BioSystems (E), Integral BioSystems (F); Kathryn Crawford, None; Thomas Leland, Integral BioSystems (E), Integral BioSystems (F)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 4140. doi:
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      Shikha P Barman, Moli Liu, Kevin Ward, Koushik Barman, Kathryn Crawford, Thomas Leland, ; A Novel, Non-invasive, Self-Administered, Preservative-Free, Sustained Release Product (EySite-TPTM) for Glaucoma Therapy. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4140.

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

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Abstract

Purpose: One of the leading causes for blindness among the elderly is glaucoma. Among leading standards of care for glaucoma treatment are prostaglandin eye-drops, administered once daily. However, treatment is confounded by lack of patient compliance, inefficient placement of drops and losses of ~90% of the dosage to drainage by the tear duct. We present feasibility data of a novel, preservative-free, self-administered, Travoprost-containing sustained release, nanoengineered product that can be placed in the conjunctival cul de sac by the patient, every 30 days.

Methods: Appropriately-sized drug-containing nanoengineered matrices were prepared using a combination of proprietary process conditions and blends of PLG/ hydrophilic polymers. Formulations varied in composition, end groups and amount and type of amphiphilic co-excipient. Travoprost-containing matrices were analyzed as followes: content (µg/mg device) by HPLC, integrity of encapsulated drug (HPLC), microstructure (SEM), in-vitro release studies at 37°C, pH 7.4 using a flow-through system and rate of hydration model developed in-house.

Results: Travoprost-containing dry nano-matrices contained 39-100 µg of intact drug per device, with >90% encapsulation efficiency. Ester-end group PLGA combined with hydrophilic polymers provided a flexible, biodegradable matrix. SEM of the matrices showed a fine nanostructure, with interconnecting pores, suitable for rapid water uptake into a flexible hydrogel, post-placement. The prototypes released Travoprost in-vitro at 37°C at a rate of 0.8-3.5 µg per day, at 65% released in 2 weeks. The nanomatrix remained flexible and hydrated throughout the study, with its hydrated flexural modulus similiar to that of ocular conjunctiva. The nanomatrix was assessed for the rate of water update and its hydration into a hydrogel. By visual assessment, the dry, flexible nanomatrix absorbed water in approximately 30 seconds to become a tissue-conforming, adherent hydrogel.

Conclusions: The data demonstrates the the feasibility of a non-invasive, preservative-free, self-administered Travaprost-containing 30-Day sustained release, biodegradable dosage form. This novel product addresses a vital clinical need and has the potential to transform drug administration for both ocular surface disorders and intraocular diseases. The sterile product is placed in the conjunctival cul de sac with an applicator.

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