Innovations in Glaucoma Drug Delivery What the Future Holds. Justin Schweitzer, OD, FAAO Vance Thompson Vision Sioux Falls, South Dakota

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1 Innovations in Glaucoma Drug Delivery What the Future Holds Justin Schweitzer, OD, FAAO Vance Thompson Vision Sioux Falls, South Dakota

2 Allergan Glaukos Bausch and Lomb Bio- Tissue Alcon TearScience Reichert

3 WHY

5 Least Scary Monitor Glaucoma Meds SLT X MIGS Filtration Surgery Cataract Surgery + MIGS Cataract Surgery Most Scary

6 Safety First After Trab Cataract 24 months TVT- Trab - 50% Failure Rate Tube - 35% Failure Rate Husain R, Liang S, Foster PJ, et al. Cataract Surgery After Trabeculectomy: The Effect on Trabeculectomy Function. Arch Ophthalmol.2012;130(2): doi: /archophthalmol

7 Barriers to Medication Compliance

9 Skepticism of Vision Loss Mistrust of Doctor Poor Self- Efficacy Poor Knowledge Regarding the Disease Skepticism Meds will Mitigate Vision Loss

10 Drop- Instillation Difficulty Drug Cost Drug Side Effects Patient Forgetfulness Issues with Medication Schedule Life Stress

11 The eye has many protective barriers, which efficiently clear foreign substances but restrict the bioavailability of applied topical agents. Ghate D, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2):

12 Spillage or nasolacrimal drainage Tearing & Blinking Tear Film Turnover Irritation and discomfort cause reflex tearing and blinking Ocular surface contact time < 5 minutes Ghate D, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2):

13 Conjunctival & Scleral Absorption greater surface area than cornea Corneal Absorption 5% of dose reaches target tissues Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;12(3): Ghate D, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Delivery. 2006;3(2):

14 ?

15 Bimatoprost Ring

16 Bimatoprost Ring 23.9 n = 49 eyes IOP mm Hg Baseline 1 mo 6 mo Month Goldberg I, Laganovska G, Baumane K, et al. The novel topical ocular insert (Helios) for sustained delivery of bimatoprost in glaucoma and ocular hypertension. Poster presented at: American Academy of Ophthalmology Annual Meeting; October 20, 2014; Chicago, IL.

17 Bimatoprost Ring Re Retention Rate 89% Brandt J, Sall K, DuBiner H, et al. Six- month intraocular pressure reduction with a topical bimatoprost ocular insert. Ophthalmology. 2016;123(8): Ophthalmology , DOI: ( /j.ophtha ) Copyright 2016 American Academy of Ophthalmology Terms and Conditions

Bimatoprost Ring Re Brandt J, Sall K, DuBiner H, et al. Six- month intraocular pressure reduction with a topical bimatoprost ocular insert. Ophthalmology.

18 Bimatoprost Ring Re Brandt J, Sall K, DuBiner H, et al. Six- month intraocular pressure reduction with a topical bimatoprost ocular insert. Ophthalmology. 2016;123(8): Ophthalmology , DOI: ( /j.ophtha ) Copyright 2016 American Academy of Ophthalmology Terms and Conditions

19 Travoprost Punctum Plug (OTX- TP, Ocular Therapeutix)

20 Travoprost Punctum Plug (OTX- TP, Ocular Therapeutix) mm Hg IOP Reduction mm Hg No hyperemia in OTX- TP Retention Rates 91, 88, days 60, 75, 90 OTX- TP timolol Ocular Therapeutix, Inc. Ocular Therapeutix TM reports on topline results of phase 2b glaucoma clinical trial. Press Release. 22 October investors.ocutx.com/phoenix.zhtml?c=253650&p=irolnewsarti- cle&id= [Accessed 6 September 2016]

22 Latanoprost- Eluting Contact Lens Attractive option secondary to large residence time in the eye.

23 Latanoprost- Eluting Contact Lens Comfort of Lens Patient Compliance Vision with Lens Dry Eye/Ocular Surface Disease Replacement Schedule

24 Preclinical Trial and Results CLHI (149g latanoprost) CLLO (97g latanoprost) VS Topical latanoprost ~ 1 week Ciolino JB, Ross AE, Tulsan R, et al. Latanoprost- eluting contact lenses in glaucomatous monkeys. Ophthalmology 2016; 123:

25 Preclinical Trial and Results Ciolino JB, Ross AE, Tulsan R, et al. Latanoprost- eluting contact lenses in glaucomatous monkeys. Ophthalmology 2016; 123:

26 Bimatoprost Intraocular Implant (Bimatoprost SR, Allergan)

27 24 Month Phase I/II Clinical Trial 75 Patients bimatoprost pellet (6, 10, 15, or 20 micrograms) topical bimatoprost 0.03%

28 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%

29 Travoprost Extended Release Implant (ENV515, ENVISIA)

30 Travoprost Extended Release Implant (ENV515, ENVISIA) Navratil T, Garcia A, Verhoeven RS, et al. Advancing ENV515 (travoprost) intracameral implant into clinical development: nonclinical evaluation of ENV515 in support of first- time- in- human phase 2a clinical study. Poster presented at: The Association for Research in Vision and Ophthalmology Annual Meeting. 2015

31 Travoprost Extended Release Implant (ENV515, ENVISIA) Baseline IOP 19.7 mm Hg (Lumigan or Xalatan) Washout IOP 26.1 mm Hg mm Hg (25%) low doseenv515 content/uploads/2017/02/draft- Press- Release- ENV515- Cohort Month- Data- Release FINAL- FINAL.pdf

32 Travoprost intraocular implant (idose, Glaukos) Resides in AC angle, anchored behind TM Length: Diameter: Titanium Non-ferrous 1.8 mm 0.5 mm

33 Travoprost intraocular implant

34 The Future

35 X

39 +

40 In Conclusion...

41 More than 90% of patients are nonadherent to their ocular medication dosing regimens, and nearly 50% discontinue taking their medications before 6 months 1 Nordstrom BL. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:

42 Corneal Thickness SLT Glaucoma Medications MIGS ONH Appearance Filtration Surgery Glaucoma Drug Delivery Devices IOP Family History OCT Visual Field

43 Thank You!

Glaucoma Surgical Treatments. Murray Fingeret, OD Justin Schweitzer, OD Joe Sowka, OD

Glaucoma Surgical Treatments. Murray Fingeret, OD Justin Schweitzer, OD Joe Sowka, OD Glaucoma Surgical Treatments Murray Fingeret, OD Justin Schweitzer, OD Joe Sowka, OD Disclosures Murray Fingeret Consultant Bausch & Lomb, Alcon, Allergan Justin Schweitzer Allergan, Glaukos, Bausch and