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Unmet Needs And Challenges With Sustained Drug Delivery To The Eye | 23529
Clinical Pharmacology & Biopharmaceutics
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Data confirm that many patients are unable to self-administer chronic eye drops effectively, including the arthritic aging
population and uncooperative pediatric glaucoma patients. Patient videos and questionnaires have demonstrated the
inability for patients to effectively self dose and administer the drops accurately and as prescribed. Recent data revealed
that only 71% of 204 glaucoma patients were able to get a drop into the eye, and only 39% did so without touching the
bottle to the surface of the eye. Such studies confirm eye drop wastage, potential contamination of the eye drop bottles, and
poor understanding of the situation among participants. Furthermore, the current standard of care for Age Related Macular
Degeneration has removed the patient from the equation, yet it is still time and resource intensive requiring roughly monthly
in office intraocular injections over years.
Thus an alternative delivery mode, with decreased frequency of administration and sustain release potential could 1)
greatly improve local ocular and systemic safety and tolerability profiles by decreasing the amount of drug delivered locally,
as well as 2) more effectively and efficiently manage ocular disease and resources by effectively targeting the disease and
reducing patient visits. There are currently several novel and innovative sustained release (SR) delivery methods in various
stages of development for both front of the eye (anterior segment and ocular surface) and back of the eye (intraocular retinal)
pathologies. To develop a viable, reproducible, SR technology one must consider 1) formulation work; standardizing the release
kinetics, and duration of action, 2) clinical study design and patient population (determining the timing of replacement or
refill, and identifying the acceptable safety risk profile compared to the comparator), 3) encouraging physician and patient
acceptance of perhaps a more invasive procedure, and 4) navigation of reimbursement issues to establish the rationale of a
perhaps more costly product over the current comparator.
This presentation will review some broad drug delivery platforms, the current landscape for treating ocular pathology with
these SR delivery modes, will discuss what data are needed in development to allow such a novel technology to be a clinically
viable marketed product, as well as the novel biodegradable polymer film being developed by my company Jade Therapeutics
for anterior segment/ corneal pathology.
Barbara M Wirostko is co founder and Chief Scientific Officer of Jade Therapeutics Inc, an Ophthalmic drug delivery company located in Utah. Prior to founding
Jade, She served as CMO of Altheos, a biotech company developing an NCE for glaucoma. A board certified ophthalmologist, she maintains an academic research
and clinical practice with the University of Utah, Moran Eye Center, as a Clinical Adjunct Associate Professor in Ophthalmology. From 2006-2010she was Senior
Medical Director within the Clinical Development Specialty division at Pfizer. She completed her glaucoma fellowship at Cornell University, and received her
Ophthalmology training as well as her medical degree at Columbia University, College of Physicians and Surgeons, NY. She serves on the editorial board of Acta
Ophthalmologic, various non-profit scientific advisory boards, and consults for companies focused on drug delivery including SKS Ocular. She is an active member
and fellow of the AAO, ARVO, Women in Ophthalmology, and various local state societies.
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