As Intraocular Lenses See Technological Evolution, FDA Looks to Reassess Clinical Evaluation Methods
Posted 06 September 2013 | By
The US Food and Drug Administration (FDA) has announced it plans to hold a joint workshop with the American Academy of Ophthalmology (AAO) to address challenges that affect the regulatory assessment of innovative intraocular lenses (IOLs).
IOLs are-as their name implies-lenses that are physically implanted into the eye, most often to treat medical conditions like cataracts which otherwise disrupt the body's own crystalline lens.
FDA's Federal Register notice on the meeting explains that surgical procedures to implant IOLs are the most commonly performed elective procedures in the US, with more than three million patients receiving an IOL since they were introduced to the market.
However, regulators say both they and industry are running into a problem. Over the last 20 years, IOL technology has evolved, outgrowing the traditional clinical trial endpoints once used to evaluate the products.
"As IOL technology evolves, some endpoints for the evaluation of the technology are also evolving," FDA wrote in its notice. "Endpoints and strategies for assessing the relative safety and effectiveness of these innovative lens designs are in various stages of development."
Working through Issues
And that, FDA said, is where an upcoming workshop is set to make an impact. Regulators and industry are set to come together on 11 October 2013 to discuss novel trial endpoints, as well as the benefits and challenges inherent in using those endpoints.
In addition, endpoints will also be "prioritized for further discussion, development and validation."
"By bringing together all of the relevant stakeholders, which include clinicians, researchers, industry representatives, and regulators, to this workshop, we hope to facilitate the improvement of regulatory science in this rapidly evolving product area," FDA wrote.
The Federal Register notice adds that four general topics are set to be discussed at the meeting:
- safety assessments for premium IOLs and how they could differ from those for monofocal IOLs
- patient-reported outcome measures and the need to develop and validate them for assessing the safety and effectiveness of premium IOLs
- objective assessments of accommodation and their challenges
- subjective assessments of accommodation and extended depth of focus and their challenges
Additional documentation released by AAO notes that the group is interested in modifying the ISO 11979-7 standard (Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations), particularly with respect to adverse event reporting.
At present, six FDA participants are scheduled to attend the meeting:
- Malvina Eydelman, MD
- Don Calogero, MS
- Gene Hilmantel, OD, MS
- Tina Kiang, MD
- Eva Rorer, MD
- Michelle Tarver, MD, PhD
Cost of attendance will be between $250 and $450, with FDA providing a free transcript of the meeting online within 45 days of the workshop's conclusion.
Federal Register Notice
AAO Meeting Details