Emerging Optometry: Ethical and Business Aspects Study Guide

Ethical Concerns and the Dilemma of Medical Breakthroughs

  • Medical breakthroughs often experience a cycle of high-intensity publicity when they reach the human testing phase.
  • Initial media coverage tends to focus on the "initial joy" of the subjects, using superlative descriptions such as "life-changing" or "I never thought I could do that."
  • There is a distinction between performing a "party trick" and completing a truly useful daily task.
    • Example: Ray Flynn was reported as "seeing with his eyes closed."
    • Example: Rhian Lewis was described as "telling the time."
    • Example: Mr. K was described as "seeing his grandchildren."
  • These "generous descriptions" of patient abilities are often used to generate public interest and secure funding from commercial entities or Research Councils.
  • Publicity serves to demonstrate "impact," which is a key metric for funding bodies.
  • The reality of medical technology is that it remains a long way off from full deployment even after publicity spikes. It must pass through:
    • Several phases of clinical trials.
    • Complex regulatory approvals.

Case Study: Science Corp and the Science Eye

  • On May 28, 2023, Science Corp, led by CEO Max Hodak, unveiled the "Science Eye."
  • Device Specifications:
    • Approximately the size of a penny.
    • Attached to a thin tail of wiring.
    • Features a miniature electronic "city" attached to a microLED display measuring exactly 2 mm22\,mm^{2}.
  • Functional Mechanism:
    • The prosthesis is implanted both on top of and inside the eyeballs.
    • It is intended for patients where light-sensing cells (photoreceptors) have died.
    • It uses optogenetics to coax other cells within the eye to receive and translate light signals.
  • Developmental Stage:
    • As of late 2022/early 2023, the device was tested on a New Zealand white rabbit named Leela (after the Futurama character).
    • The rabbit received an injection through the white of her eyeball approximately one month prior to surgical demonstrations.
  • Academic/Scientific Transparency:
    • A preprint was posted on bioRxiv on February 06, 2023, titled "A thin-film optogenetic visual prosthesis."
    • Authors include Eric B. Knudsen, Kara Zappitelli, Jennifer Brown, Jonathan Reeder, Kevin Sean Smith, Marat Rostov, Jaebin Choi, Amy Rochford, Nate Slager, Satoru K. Miura, Kyle Rodgers, Ansel Reed, Yonatan R. Lewis-Israeli, Seton Shiraga, Kyung Jin Seo, Corey Wolin, Paul Dawson, Mohamed Eltaeb, Arvind Dasgupta, Max Rothman, Eugene Yoon, Paul Chong, Seleipiri Charles, Jay M. Stewart, Ruwan A. Silva, Tyson Kim, Yifan Kong, Alan R. Mardinly, and Max Hodak.
    • Conflict of Interest: A "Red Flag" noted is that all authors on the preprint have a financial interest in Science Corporation.

Global Competition in Vision Prosthesis

  • The field of vision restoration is described as a highly competitive "race," though few groups reach the stage of clinical success.
  • Active international groups as of November 2019 (excluding those focused purely on genetic or transplantation strategies) include:
    • North America: PolyStim Neurotechnologies (Montreal), Ionie (Ottawa), University of Michigan, Massachusetts General Hospital (Boston), ICVP @ Illinois Institute of Technology, University of Washington (Seattle), UC Santa Barbara, Stanford University, Bionic Eye Technologies (Ithaca/Boston), Second Sight Medical Products (Sylmar), Nanovision Biosciences (San Diego), UC San Diego, Utah Intracortical Electrode Array, University of Houston/NASA, Neural Prosthesis Program (Bethesda), Johns Hopkins University, Visual Sensory Devices (FDA CDRH Research Program), and Detroit Institute of Ophthalmology/Henry Ford Health System.
    • Europe: EpiRet (Aachen), NESTOR (Amsterdam), Newcastle University (UK), Pixium (Paris), PolyRetina (Lausanne), Technical University of Denmark, InAuka @ University of Bremen, Tuebingen University (Germany), Vienna University of Technology, CORTIVIS (Alicante), and VISNE (University of Madrid).
    • Middle East and Asia: Gazi University (Ankara), Koc University (Istanbul), Ain Shams University (Cairo), Quantum Retina (Tel Aviv University), Bar-Ilan University (Israel), NanoRetina (Herzliya), Fudan University (Shanghai), Nurotron (Hangzhou), Biohybrid Retinal Implant (Tokyo), Japanese Artificial Vision Project (Osaka), Okayama University, Doshisha University (Kyoto), SSADE Korean Retinal Prosthesis Group (Seoul), SiBionics (Shenzhen), Shenzhen Institute of Advanced Technology, and Iridium (Taipei).
    • Oceania: Bionic Vision Technologies (Melbourne & Canberra), Phoenix 99 (University of New South Wales and University of Sydney), and Monash Vision Group (Melbourne).

Business and Economic Realities of Vision Care

  • Cost and Value:
    • Each device is extremely expensive, and companies must recoup heavy R&D investments.
    • There is a requirement to prove "value for money" and cost-effectiveness for health systems to adopt the tech.
  • The Rehabilitation Problem:
    • Post-surgical rehabilitation and training are essential for patient success but are often described as "not sexy or exciting" compared to technical surgical developments.
  • Patient Population Limits:
    • The eligible population for these devices is very limited.
    • Manchester Royal Eye Hospital (MREH) received approval in 2016 for a trial specifically in Age-related Macular Degeneration (AMD) patients.
  • Market Expansion:
    • Business press (e.g., Forbes) focused on the expansion of "addressable markets."
    • Second Sight’s Argus II was originally for Retinitis Pigmentosa (RP) with an eligible global population of 375,000375,000.
    • Expanding the indication to AMD quintupled the market to an eligible population of 2,000,0002,000,000.

Corporate Failures and Ethical Consequences

  • The history of the field is marked by significant company failures.
  • Second Sight Medical Products:
    • Developed the Argus retinal prosthesis, implanted in 350350 patients worldwide over 1010 years.
    • Developed Orion I, a cortical implant based on Argus technology (90%90\% technology transfer).
    • Orion I aimed for a global population of 6,000,0006,000,000 patients (those ineligible for retinal implants).
    • Second Sight ran out of money in 2020. It was taken over by Cortigent.
    • Consequence: The Argus system was abandoned. Patients were left without training support, spare parts, or software updates.
  • Retina Implant AG:
    • Dissolved on March 19, 2019, following an extraordinary general meeting.
    • Reasons for closure: Lack of groundbreaking medical progress after 1616 years of research and an "innovation-hostile climate" in Europe’s regulatory and health systems.
    • The company had sufficient resources for an "orderly and responsible" closure.
  • Pixium Vision:
    • Developed the PRIMA system for dry AMD.
    • Trials: One European trial with 3838 patients and another with 1010.
    • Qualifying visual acuity for these trials was logMAR 1.2\text{logMAR } 1.2.
    • Latest Status: The court rejected an acquisition offer from NeuroTech; Pixium was placed in liquidation with immediate effect and cessation of activities.