New Innovations on Ophthalmology
Glaucoma Drug Delivery Technologies
AAO 2012 Media Briefing Session
Andrew G. Iwach, M.D.
Associate Clinical Professor
University of California, San Francisco
San Francisco, California
Financial Disclosure
• I have the following financial interests or relationships to disclose:
• Consultant
–
–
–
–
AcuMEMS
Carl Zeiss Meditec
Clarity Medical Systems
IRIDEX
• Lecture Fees
–
–
–
–
–
–
Alcon Laboratories, Inc.
Carl Zeiss Meditec
Ellex Laser Systems
IRIDEX
Lumenis, Inc.
Merck U.S. Human Health
IOP Lowering Medications
NRx Shares 2001 - 2008
NRx EQUN Share
50%
PGs
40%
30%
Total BBs
20%
Alpha Agonists
Tim/Dorz
10%
CAIs
0%
2001
2002
2003
Source: WK Health NRx Share 2001-YTD 2008
2004
2005
2006
2007
YTD 2008
The Concept of Persistency
Persistent Patients (%)
Impacting Factors
100
90
80
70
60
50
40
30
20
10
0
3 mo
6 mo
Ideal
After human complacency/denial
With complicated dosing
9 mo
With added side effects
With economic issues
12 mo
• Glaucoma 360
Compliance Solutions: Drug Delivery Options
www.clearsidebio.com
Sustained Drug Delivery from In Situ Polymerizing
Collagen Gels and Preformed Collagen-based
Membranes
• Background of Collagen Gel and Collagen
Membrane Drug Delivery
– Description of In Situ Polymerizing Collagen Gel
– Patent Application Filed
• Pilot In vitro studies of Latanoprost Release
– Euclid Systems Corp
Euclid Systems Corporation (dba Euclid Vision Systems)
Herndon, VA
In situ Polymerizable collagen
Collagen added to 0.15M NaCl
<1 minute after addition to 0.15M
NaCl
Base Collagen Wafer
Insertion wafer cut to 2mm x 4mm size
Preliminary Rabbit Study-Crescent
Wafer Insertion
In vitro Release Study-Wafers ELISA
Summary
• Euclid Systems Corporation has developed two collagenbased compositions providing sustained release of
Latanoprost for treatment of glaucoma
1. Injectable, in situ gelling collagen solution that was shown in
laboratory evaluations to provide sustained release of
Latanoprost for up to 27 days (study terminated at 27 days)
2. Implantable collagen wafers shown in laboratory evaluations to
provide sustained release of Latanoprost for up to 180 days
Ocular Therapeutix, Inc.
• Company:
– Develops innovative hydrogel-based therapies for management of ocular surgeries and diseases
– Product Pipeline:
•
•
•
OTX-TP: Sustained release travoprost for treatment of glaucoma
OTX-DP: Sustained release dexamethasone for post-operative inflammation
ReSure® Sealant* for prevention of fluid egress from clear corneal wounds
Drug-eluting punctum plugs
ReSure® Sealant
*ReSure Sealant is limited by federal (U.S) law to investigational use only. ReSure Sealant is not commercially available in any geography.
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Sustained Release Travoprost (OTX-TP)
• Intended use:
Punctum plug size
– Reduction of intraocular pressure in patients with
open-angle glaucoma or ocular hypertension
• Product design:
–
–
–
–
Non-invasive punctum plug formulation
Tailored drug release (2-3 months)
Visible for retention monitoring
Comfortable and absorbable
Fluorescent plug
observed under blue light
• Components:
–
–
–
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Polyethylene glycol hydrogel
PLA microparticles
Travoprost ophthalmic solution
Fluorescein
14
Ocular Therapeutix, Inc.
Sustained Release Travoprost (OTX-TP)
Intraocular Pressure Reduction from Baseline
Baseline: 26.4 mm Hg
16 subjects; 24 eyes
Average IOP Reduction (mmHg)
0
-1
-2
-3
-4
-5
-6
-7
-8
0
5
10
15
Days
20
25
30
Error bars = SEM
15
*Data on file at Ocular Therapeutix
Sustained Release Travoprost (OTX-TP)
Hyperemia
Hyperemia Score (0 to 4)
n=24
4
3
Baseline
2
1
0
0
0 = None
5
10
1 = Trace
*Data on file at Ocular Therapeutix
15
Days
2 = Mild
20
25
30
Error Bars = Standard deviation
3 = Moderate
4 = Severe
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http://www.qltinc.com/
http://amorphextherapeutics.wordpress.com
http://www.psivida.com
http://www.replenishinc.com
Glaucoma Center of San Francisco
www.GlaucomaSF.com
Glaucoma Center of San Francisco
www.GlaucomaSF.com