The Biomedical Ocular Coil Drug delivery Comfort (OCDC) project

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Catherine Hudson
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1 The Biomedical Ocular Coil Drug delivery Comfort (OCDC) project Prof.dr. R.M.M.A. Nuijts (MUMC+) Dr. A. Dias (Eyegle BV) Prof.dr. R. Tuinier (TU/e) I. Schefman, BA (Eyegle BV) Dr. H. Theunissen (MVC, Part. Rep.)

2 Current Practice in Ocular Drug Delivery In treatment and prevention of ocular diseases eye (e.g. infections, glaucoma) drops are often the first line of defence Patients frequently use multiple eyedrops out of multiple bottles

3 Current Practice: Problems with Eyedrops Current ocular drug delivery is suboptimal: Non-compliance in 50% of patients with chronic eye disease (eg. glaucoma) Suboptimal ocular drug absorption Occurrence of local and systemic side effects (allergic and toxic) Courtesy Eric Donnenfeld, MD

carriers to improve drug delivery in eye diseases like cataract surgery and

4 Unmet Need Ophthalmology: Optimize Ocular Drug Delivery Ocular drug delivery is clearly suboptimal We need: smarter biomaterials as drug carriers to improve drug delivery in eye diseases like cataract surgery and glaucoma First goal is no drops before or after cataract surgery: Dropless Cataract surgery

5 InSciTe Ophthalmology: OCDC-project The biomedical Ocular Coil Drug delivery Comfort (OCDC) project Alternative for eyedrops Purpose: to incorporate drugs into a smart biomaterial for sustained drug release POP: Drug delivery before and after cataract surgery

Cataract: A Global Health Problem Cataract: most frequent cause

intraocular lens (IOL) is most commonly performed surgery: > 180.

western Europe (2011) By 2020, globally 32 million cataract

6 Cataract: A Global Health Problem Cataract: most frequent cause (33%) of global blindness Cataract surgery with implantation of an intraocular lens (IOL) is most commonly performed surgery: > cataract surgeries per year in NL (2012) 3 million times in western Europe (2011) By 2020, globally 32 million cataract operations p/yr will be performed (WHO)

7 Cataract Surgery: Surgical Technique Surgical technique : 2.2 mm wound Divide and conquer process of the lens

8 Cataract Surgery: Surgical Technique Removal of natural lens and implantation of artificial intraocular lens Lens Implantation

9 Cataract Surgery: Incidence of Complications Posterior capsule opacification (20%) Cystoid macular edema (CME) (4 20%) Endophthalmitis ( %) Cystoid macular edema (OCT)

10 ESCRS PREMED study: PREvention of Macular EDema NSAID VS. Steroids

11 Prevention of CME: NSAIDs more Effective than Steroids Systematic review & metaanalysis Anti-inflammatory drops after cataract surgery Topical NSAID Topical NSAIDs appear more effective than corticosteroids in prevention of macular edema Wielders, AJO in press:

12 InSciTe Ophthalmology: the OCDC-project The biomedical Ocular Coil Drug delivery Comfort (OCDC) project Purpose: to incorporate an NSAID into a smart biomaterial for sustained drug release To determine the efficacy and safety of such a device in animal and human experiments

13 OCDC-project: Proposed Route is an Ocular Insert

14 Why an Ocular Insert? Advantages of an ocular insert over traditional eyedrops: Higher bioavailability compared to standard eye drops Prolonged release of drugs in cataract surgery up to 3 weeks Insert contains a precise dose Dose is fully retained at the administration site Allowance of drug combinations (antibiotics, steroids, NSAIDS)

15 OCDC-Project Development: Phase 1 to 4 Phase 1: Coil development Phase 2: Drug-loaded microspheres Phase 3: Human safety and comfort trial Phase 4: Animal efficacy trial

16 OCDC-Project: #1 Ocular Coil Development To prepare microsphere loaded coils with sufficient dimensions, flexibility, and lubricity to ensure patient comfort Hollow wire covered with a proprietary coating Length 16.0mm Lumen will be filled with drug-loaded microspheres Coiling process

17 OCDC-Project: #2 Microsphere Drug Loading Fill the microspheres with NSAID to obtain constant (sustained) drug delivery Drug (NSAID)

18 OCDC-Project: #3 Human Comfort Trial To evaluate the tolerance and safety of the non-drug loaded ocular coil: Coil placement from 4h to 4 wks Evaluate ocular redness and discomfort (imaging and questionnaires) Challenges: Tolerance for extended period of time upto 4 wks Retention of the coil Adverse effects (irritation)

19 OCDC-Project: #4 Animal Efficacy Trial To evaluate in vivo absorption of ketorolac applied as an eye drop vs. a ketorolac loaded ocular coil in rabbit eyes A comparative in vivo animal cohort study (rabbits): Placement for 4 hrs to 4 wks Evaluate pharmacokinetics of ketorolac (coil vs. drop) To quantify ocular irritation Challenges: Retention of the coil (nictitating membrane) Sufficient sustained release

completion will lead to implementation of coil technology into fields where

20 OCDC-Project: Economic Value Creation Present focus is to demonstrate POC in an anti-inflammatory model in human postoperative cataract surgery Successful completion will lead to implementation of coil technology into fields where topical treatment is the standard of care: glaucoma, dry eye, infections Cataract Glaucoma

problems with retention and dislocation Mydriasert (Spectrum Thea, UK, 2010)

21 Are there Similar Ideas? Competition? Ocusert (Alza, US, 1974) Insoluble ocular insert Withdrawn from the market problems with retention and dislocation Mydriasert (Spectrum Thea, UK, 2010) Soluble ocular insert Presurgical pupil dilation before cataract surgery: 8 per insert (vs. drops 1.50) 30% market penetration in NL,

22 Are there Similar Ideas? Competition? Bimatoprost insert (ForSight Helios, US, AAO 2014) Insoluble ocular insert to lower IOP 4-6 months drug delivery Phase 1 FDA trials Punctum plug insert (Ocular Therapeutix, US, 2013) Biodegradable to reduce inflammation 4 wks drug delivery Phase 3 FDA trials 22

Conclusion: Need to Optimize Ocular Drug Delivery Current ocular drug delivery is clearly suboptimal Topical medications (eyedrop) as we know them today will change greatly over the next

23 Conclusion: Need to Optimize Ocular Drug Delivery Current ocular drug delivery is clearly suboptimal Topical medications (eyedrop) as we know them today will change greatly over the next several years We need: smarter biomaterials as drug carriers to improve sustained drug delivery to the anterior and posterior parts of the eye Our first goal is to develop a drug-loaded ocular coil

24 Thank You The InSciTe Board and Management team, Founding Fathers The OCDC Project team The University Eye Clinic of MUMC+ Information:

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

Innovations in Glaucoma Drug Delivery What the Future Holds Justin Schweitzer, OD, FAAO Vance Thompson Vision Sioux Falls, South Dakota Allergan Glaukos Bausch and Lomb Bio- Tissue Alcon TearScience Reichert