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4/15/17
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Innovations in Glaucoma Drug DeliveryWhat the Future Holds
Justin Schweitzer, OD, FAAOVance Thompson VisionSioux Falls, South Dakota
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AllerganGlaukos
Bausch and LombBio-‐TissueAlcon
BioTissueReichert
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WHY
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2020
> 3 Million Americans
Least Scary
Monitor
Glaucoma MedsSLT
Cataract Surgery
Cataract Surgery + MIGS
MIGSFiltration Surgery
Most Scary
XSafety First
After Trab – Cataract Develops @ 24 months
TVT-‐Trab -‐50% Failure RateTube -‐35% Failure Rate
Husain R, Liang S, Fo ste r P J, et al. Cataract Su rge ry Afte r Trabe cu le ctomy: The Effe ct on Trabe cu le ctomy Function. Arch Oph tha lmo l.2 0 12 ;13 0(2 ):1 65 -‐17 0 . doi:10 .10 01 /archophthalmo l.20 11 .32 9.
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Barriers to Medication Compliance
Skepticism of Vision Loss
Skepticism Meds will Mitigate Vision Loss
Poor Self-‐Efficacy
Poor Knowledge Regarding the Disease
Mistrust of Doctor
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Drop-‐Instillation Difficulty
Issues with Medication Schedule
Drug Cost
Patient ForgetfulnessDrug Side Effects
Life Stress
The eye has many protective barriers, which efficiently clear foreign substances but restrict the bioavailability of
applied topical agents.
GhateD, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2) : 275-‐287
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Ocular surface contact time < 5 minutes
Spillage or nasolacrimal drainage Tearing & Blinking
Tear Film Turnover
Irritation and discomfort cause reflex tearing and blinking
GhateD, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2) : 275-‐287
5% of dose reaches target tissues
Conjunctival & Scleral Absorptiongreater surface area than cornea Corneal Absorption
GaudanaR, AnanthulaHK, ParenkyA, Mitra AK. Ocular drug delivery. AAPS J. 2010;12(3) :348-‐360GhateD, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2) : 275-‐287
?
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Bimatoprost Ring
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Goldberg I, Laganovska G, Baumane K, et al. The novel topical ocular insert (Helios ) for sustained delivery of bimatoprost in glaucoma and ocular hypertens ion. Poster presented at: American Academy of Ophthalmology Annual Meeting; October 20, 2014; Chicago, IL.
n = 49 eyes
IOP mm Hg
MonthBaseline 1 mo 6 mo
23.9
18.7 18.8
0
5
10
15
20
Bimatoprost Ring
O pht halmology 2016 123, 1685- 1694DO I : ( 10. 1016/ j. opht ha. 2016. 04. 026)
Copyr ight © 2016 Amer ican Academy of O pht halmology Terms and Condit ions
Brandt J, Sall K, DuBiner H, et al. Six-‐month intraocular pressure reduction with a topical bimatoprost ocular insert. Ophthalmology. 2016;123(8):1685-‐1694.
Bimatoprost Ring
Re
Retention Rate – 89%
O pht halmology 2016 123, 1685- 1694DO I : ( 10. 1016/ j. opht ha. 2016. 04. 026)
Copyr ight © 2016 Amer ican Academy of O pht halmology Terms and Condit ions
Brandt J, Sall K, DuBiner H, et al. Six-‐month intraocular pressure reduction with a topical bimatoprost ocular insert. Ophthalmology. 2016;123(8):1685-‐1694.
Bimatoprost Ring
Re
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Helios Ring
Travoprost Punctum Plug(OTX-‐TP, Ocular Therapeutix)
Travoprost Punctum Plug(OTX-‐TP, Ocular Therapeutix)
Ocular Therapeutix, Inc. Ocular Therapeutix TM reports on topline results of phase 2b glaucoma clinical trial. Press Release. 22 October 2016. http:// inves tors .ocutx.com/phoenix.zhtml?c=253650&p=irol-newsArti- cle&ID=2100516. [Accessed 6 September 2016]
IOP Reduction
OTX-‐TP timolol
4.5-‐5.7 mm Hg
6.4-‐7.6 mm Hg
0
5
10
No hyperemia in OTX-‐TP
Retention Rates 91, 88, 48% @ days 60, 75, 90
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Latanoprost-‐Eluting Contact Lens
Attractive option secondary to large residence time in the eye.
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Latanoprost-‐Eluting Contact LensComfort of Lens
Vision with Lens
Dry Eye/Ocular Surface DiseaseReplacement Schedule
Patient Compliance
Preclinical Trial and Results
Ciolino JB, Ross AE, Tulsan R, et al. Latanoprost-‐eluting contact lenses in glaucomatous monkeys . Ophthalmology 2016; 123:2085 – 2092.
CLHI (149g latanoprost) CLLO (97g latanoprost)
Topical latanoprost
VS
~ 1 week
Preclinical Trial and Results
Ciolino JB, Ross AE, Tulsan R, et al. Latanoprost-‐eluting contact lenses in glaucomatous monkeys . Ophthalmology 2016; 123:2085 – 2092.
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Bimatoprost Intraocular Implant(Bimatoprost SR, Allergan)
24 Month Phase I/II Clinical Trial
75 Patients
bimatoprost pellet(6, 10, 15, or 20 micrograms)
topical bimatoprost 0.03%
24 Month Phase I/II Clinical Trial
bimatoprost pellet(6, 10, 15, or 20 micrograms)
topical bimatoprost 0.03%
4 months – IOP reduction 7.2, 7.4, 8.1, 9.5 mm Hg
92% of patients
4 months – IOP reduction of 8.4 mm Hg
Sustained at 6 mos. in 71%
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% ConjunctivalHyperemia
52%Implant group
30.7%Topical group
Side Effects
Safety
Travoprost Extended Release Implant(ENV515, ENVISIA)
Travoprost Extended Release Implant(ENV515, ENVISIA)
Navrati l T, Garcia A, Verhoeven RS, et al . Ad van cin g ENV5 1 5 (travop ro st) in tracameral imp lan t in tocl in ical d evelopmen t: n on cl in ical evalu ation o f ENV5 1 5 in suppo rt o f fi rst-‐time-‐in -‐human phase
2 a cl in ical stud y. P o ster p resen ted at: The Asso ciation fo r Research in Vision and Oph thalmo lo gy Annual Meetin g. 2 0 1 5
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Travoprost Extended Release Implant(ENV515, ENVISIA)
http ://www.envisiath erap eu tics. com /wp -‐ con ten t/up lo ad s/2 0 1 7 /0 2 /Draf t-‐P re ss-‐R ele as e-‐ ENV5 1 5 -‐Coho rt-‐2 -‐1 1 -‐Mon th -‐Data-‐R ele as e-‐2 -‐2 -‐2 0 1 7 -‐FINAL-‐FINAL.pd f
Baseline IOP 19.7 mm Hg (Lumigan or Xalatan)
-‐6.7 mm Hg (25%) low doseENV515
Washout IOP 26.1 mm Hg
Travoprost intraocular implant
• Length: 1.8 mm• Diameter: 0.5 mm• Titanium• Non-ferrous
Resides in AC angle, anchored behind TM
(iDose, Glaukos)
Travoprost intraocular implant
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First iDose implant in the U.S. performed by Dr. John Berdahl M.D. in Sioux Falls SD, Vance Thompson Vision on March 29, 2016
The Future
X
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+
In Conclusion...
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More than 90% of patients are nonadherentto their ocular medication dosing regimens, and nearly 50% discontinue taking their
medications before 6 months1Nordstrom BL. Pers is tence and adherence with topical glaucoma therapy. Am J Ophthalmol.
2005;140:598-‐596
Visual Field
Corneal Thickness
Drug Delivery Devices
OCT
SLT
Glaucoma Medications
Filtration Surgery
Glaucoma
IOP
MIGS
ONH Appearance
Family History
Thank You!
