This document discusses novel applications of polymers in ocular medical devices, specifically contact lenses and drug delivery systems to the eye. It describes the traditional lathe process for producing contact lenses and introduces newer spin casting and cast molding techniques that allow for a smoother, higher quality finished lens. The document also discusses previous unsuccessful attempts at ocular drug delivery systems and introduces a new minidisc technology, a cast molded flexible polymeric disc that can provide sustained drug release directly to the eye. The minidisc shows promise for effectively treating eye infections while overcoming limitations of past approaches like interference with vision, short duration, and falling out. Regulatory and business challenges of commercializing such a medical device are also reviewed.

1. Novel Aspects of Polymer Use
& Processing
Contact Lenses & Ocular Drug
Delivery Systems

2. Polymers Are Omnipresent
• Automobiles
• Food & Beverage
• Energy – oil, solar panels, wind turbines
• Computers & Telecommunications
• Medical
• Pharmaceuticals

3. Polymers in Medical Devices
• Syringes, needles
• Bandages & Dressings
• Equipment
• Prosthetics – Artificial Limbs
• Implants – Heart valves, Dental Implants
• Drug Delivery

4. Ocular Medical Devices
• Contact Lenses
• Drug Delivery Systems

5. Contact Lenses
• Traditionally – Monomer Mix Heat Cast Rods
• Discs (Buttons) Cut
• Chucked & Lathed One Side
• Re-Chucked & Lathed Other Side
• Polished/Buffed
• Hydrated and Residual Monomers Extracted
• Labor Intensive & Scratch Marks Interfere
with Resolution – Less Visual Acuity

6. SpinCasting
• Highly Finished (Optical Surface)
• Monomer Mix Injected with UV Initiator
• Under Nitrogen Blanket – prevents “poisoning”
• Free Spin Surface Generated – Parabola
• Dynamic Equilibrium Established
• Polymerized by UV Lights
• Edges Finished
• Hydrated & Residual Monomers Extracted
• Sterilized & Vialed

7. Spincasting Process
Nitrogen

8. SpinCasting (Wichterle)
• Bausch & Lomb Acquired Rights
• 25cents + $1 for vial – Sold for $90/lens
• Lathed Lens Cost = $9.00/lens – Sold for $90
• B&L Allowed Competitors to Survive
• Johnson & Johnson Developed Cast Molding

9. CASTMOLDING

10. Cast Molded Contact Lenses
• One Mold Placed on Top of the Other
• Monomer Mix in Between
• Heat Initiated Polymerization
• Cost in Between Spinning & Lathing
• True Sphere Resulted in Superior Optics
• Better Resolution Than Parabola
• Superior Visual Acuity

11. Ocular Drug Delivery Systems
• Eye Maintains Homeostasis of 7.5 microliters
• Typical Drop Size is 50 microliters
• Excess Fluid Cleared from Eye
• Rolls down cheeks or flows down Naso-Lacrimal
Duct
• Severe Eye Infections – Patient Hospitalized
• Nurse Administers Medication every 5 mins!

12. Fig 1

13. Previous Attempts
• Gels – short lasting, interference with vision
• Creams – same as gels
• Contact Lenses Soaked in Drug Solutions – not
long lasting enough
• Lacrisert – Merck – dry eye interferes with vision
• Ocusert (Pilocarpine for Glaucoma) – Alza Corp.
– flat oval falls out during use

14. Requirements of Ocular Drug Delivery
Systems
• Sterility
• Comfort
• Versatility – long lasting/short lasting
• Non-Interference With Vision
• Oxygen Permeability
• Should not fall out of eye during use

15. Minidisc
• Cast Molded Shaped Concavo-Convex
• Mini “Contact Lens”
• Slightly Steeper Base Curve Against Eye –
slight suction
• Flexibility of Choice of Monomer Mix
allows Variable Physico-Chemical
Properties
• Hydrophobic to Hydrophilic Drugs
• Sterile – Gamma Irradiation

16. Constituents of the Minidisc

17. Figure 3

18. Distribution of Fluorescein in
Human Eye

19. In-Vitro Release Kinetics

20. In-Vivo Release Kinetics

21. Resolution of Eye Infection

22. Effect of Varying Acid Content

23. Mathematical Modelling

24. Implications For Ocular Health
• Many Eye Camps in India
• People from Rural Areas Transported
• Infection Rate Very High
• Have to be Retained in Clinic
• Interference with Life and Economic
Hardship
• Treat with Minidisc & Send Home

25. Questions??

26. General Entrepreneurship
Challenges
• Funding
• IP Protection
• Legal/SEC Compliance
• Personnel
• Cheaper Competition Global
Marketplace – China & India

27. ADDITIONAL CHALLENGES IN
LIFESCIENCES
• Regulatory Agencies – FDA/USDA
• Rigorous SOPs
• Stringent Quality Assurance Systems
• On-Going Training of Personnel
• Periodic On-Site Inspections
• Establishing Credibility as “Foreigner”
• Questionable Practices by Foreign Based
Firms

28. REGULATORY PROCESS
• PK/TK Studies
• Acute Toxicity (1 month)
• IND
• Chronic Toxicity (3,6,9 mths – 2 species)
• DART Studies for NCEs, Seg I, II, III
• NDA (New Drug Approval)
• Carcinogenicity Studies

29. REGULATORY PROCESS
(cont)
• Human Clinical Trials
• PHASE –I (normal volunteers)
• PHASE –II (diseased patients, single
center)
• PHASE –III (diseased patients, multi-
center)
• NDA APPROVAL

30. Cheaper Competition Global Marketplace –
China & India
• Language (China not India)!   
• Unfamiliarity with Common Formulation
Practices
• Unethical Business Practices
• Studies Have to be Repeated in
Compliance with FDA Regulations
• Small Start-Ups Go Belly-Up!

31. Questions???
• THANK YOU VERY MUCH FOR
ATTENDING
• SURVEY TO PROVIDE FEEDBACK