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Light Adjustable Lens (LAL) Phase III FDA Clinical Study

Light Adjustable Lens (LAL) Phase III FDA Clinical Study. Caution –INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE ONLY. Shamik Bafna , MD William Wiley, MD Cleveland Eye Clinic. What is the Light Adjustable Lens (LAL ® )?.

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Light Adjustable Lens (LAL) Phase III FDA Clinical Study

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  1. Light Adjustable Lens (LAL)Phase III FDA Clinical Study Caution –INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE ONLY. ShamikBafna, MD William Wiley, MD Cleveland Eye Clinic

  2. What is the Light Adjustable Lens (LAL®)? • It was developed by Dan Schwartz, MD, (Professor of Ophthalmology, University of California San Francisco), and Robert Grubbs, Ph.D. (Professor of Chemistry at Caltech and a Nobel Laureate in Chemistry, 2005) • The LAL is the first lens designed to be adjusted afterthe lens has been implanted and the eye has healed. • This can be achieved by treating the lens with UV light.

  3. Calhoun History • Initial research (1996-2000) performed as a joint collaboration between California Institute of Technology and UCSF School of Medicine • Dan Schwartz, MD (UCSF) • Robert Grubbs, PhD (Cal Tech) • Julie Kornfield, PhD (Cal Tech) • Christian Sandstedt, PhD (Cal Tech) • JagdishJethmalani, PhD (Cal Tech)

  4. Calhoun Vision Co-Founder,Dr. Robert Grubbs, wins 2005 Nobel Prize in Chemistry

  5. The Light Adjustable Lens (LAL®)? • The LAL has the potential to change the global landscape of cataract surgery as the only lens in the world whose power can be adjusted after implantation in a patient’s eye • Designed for a customized and predictable correction of residual refractive error after lens implantation for optimal distance vision • Spherical and cylindrical errors up to 2D

  6. Limitations of Currently Available IOLs • Unpredictable wound healing, errors in biometry, and posterior capsular shrinkage can offset IOL power calculation and lead to postoperative refractive errors. • The result is the need for glasses, contact lenses, or additional surgery to treat the refractive error in a substantial number of patients.

  7. Refractive Accuracy Studies Illustrate Need for an Adjustable IOL • 5 – 30% of patients require secondary enhancement procedure to improve visual outcomes. • European Results: Light Adjustable Lens (Hengerer et al, Ophthalmology 2011): 97% ± 0.25 D 98% ± 0.50 D 100% ± 1.00 D Source: 2013 Market Scope IOL Report

  8. Light Adjustable Lens • 3-piece IOL design • Blue PMMA modified-C haptics • Photosensitive silicone • 6.0mm biconvex optic; Overall length 13.0mm • Diopter Power: +10.0 to +15.0 D and +25.0 to +30.0 D in 1.0 D increments; +16.0 to +24.0 D in 0.5 D increments • Posterior layer of 100 um or less with higher concentration of UV absorber • Optic edge: Square on posterior surface; Round on anterior surface

  9. ~14 µm Light Delivery Device • Standard slit-lamp footprint • Flexibility for lens modification • The heart is the digital mirror device (DMD), which allows generation of customized spatial irradiance profiles

  10. Light Delivery Device

  11. LAL Procedure • Conventional cataract surgery • Subject has 1st adjustment of the LAL 17-21 days after surgery. • Light Delivery Device irradiates the LAL with spatially profiled beam • At 3-5 days following the 1st adjustment, either a 2nd adjustment or 1st lock-in is performed based on the subject’s refraction. • At 3-5 days following 1st lock-in, the patient returns for a second and final lock-in.

  12. Mechanism of Action Adding Power to the LAL

  13. Negative Adjustment Profile 1.2 1 0.8 Normalized Irradiance 0.6 0.4 0.2 0 -4 -3 -2 -1 0 1 2 3 4 Distance (mm) Positive Adjustment Profile 1.2 1 0.8 Normalized Irradiance 0.6 0.4 0.2 0 -4 -3 -2 -1 0 1 2 3 4 Distance (mm) Astigmatic Adjustment Profile 1.2 1 0.8 0.6 Normlalized Irradiance 0.4 0.2 0 -4 -3 -2 -1 0 1 2 3 4 Distance (mm) Adjustment Profiles

  14. LAL Phase III Clinical Study • A Prospective Randomized Controlled Clinical Study To Evaluate the Safety and Effectiveness of the LAL in subjects with Pre-Existing Corneal Astigmatism. • The LAL Phase III clinical study involves the treatment of 600 eyes monocularly. • 400 LAL eyes • 200 control eyes

  15. Phase III Study/Subject Information & Criteria • Study designed to show sphero-cylindrical correction with the LAL • Subjects receive up to $600 for full participation in the study • Requires subject follow-ups for one year • Only one eye per subject can be enrolled • Subjects are randomized to either an LAL or standard monofocal IOL in ratio of 2 out of 3 subjects receiving the LAL • Subject cannot have had previous LASIK surgery • Subject must have corneal cyl of 0.75 – 2.00 D

  16. UV Blocking Eyewear • Study patients are required to wear UV-protective glasses at all times (indoors and outdoors), except for showering and sleeping, until the light treatments are completed

  17. Study Criteria • Have a visually significant cataract. • Be between the ages of 40 to 80. • Have some pre-existing corneal astigmatism. • Have not had previous corneal refractive surgery such as RK, PRK, or LASIK. • Have no ocular problems as determined by the surgeon. • Not be using UV-light sensitive drugs: • HCTZ, tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen

  18. European Clinical Results • Ruhr University Eye Hospital, Bochum, Germany • Professor Burkhard Dick, MD • Professor Fritz Hengerer, MD • Ina Conrad-Hengerer, MD

  19. Post-adjustment UCVA Compared to Pre-adjustment UCVA (European results of 121 Eyes, 18-months post lock-in) Source: Hengerer et al, Ophthalmology 2011; 118:2382-2388.

  20. Accuracy of Spherical Equivalent Refraction (European Results of 121 Eyes, 18-months post lock-in) Source: Hengerer et al, Ophthalmology 2011; 118:2382-2388.

  21. Stability of Visual Outcome:Unchanged after 18 months(European Results of 121 Eyes, 18-months post lock-in) Source: Hengerer et al, Ophthalmology 2011; 118:2382-2388.

  22. CEC Clinical Results Pre-Adjustment Astigmatism Compared with 1 Week Post Lock-in Patient astigmatism pre-adjustment (17-21 days after implant) Patient astigmatism one week after lock-in

  23. CEC Clinical Results Correction of Astigmatism: Pre-Adjustment vs 1 week Post Lock-In ≤ ≤ ≤ ≤

  24. CEC Clinical Results Reduction of MRSEPre-Adjustment vs 1 Week Post Lock-In 100% ≤ ≤ ≤

  25. CEC Clinical Results BSCVA vs UCVAPre-Adjustment vs 1 Week Post Lock-In

  26. CEC Clinical Results UCVAPre-Adjustment vs 1 Week Post Lock-In

  27. The Calhoun Vision Light Adjustable Lens • Designed to predictably achieve excellent distance acuityand customized to each patient’s unique eye measurements.

  28. Thank you

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