If you’re an executive at an ophthalmic drug development company and desire a frank discussion on regulatory issues that are critical to your business, you’d certainly jump at the chance to invite to breakfast Wiley Chambers, MD, deputy director of the Division of Transplant and Ophthalmology Products within FDA’s Center for Drug Evaluation and Research. And if you’re an ophthalmic device company exec interested in the same topic, you’d enthusiastically seek to dine with Malvina Eydelman, MD, director of FDA’s Division of Ophthalmic and Ear, Nose & Throat Devices. Your problem, of course, would be getting these two top FDA ophthalmic officials to actually show up at your hypothetical repast.
Luckily for OIS@AAO attendees, Emmett Cunningham, MD, PhD, doesn’t have this problem. A general partner at Clarus Ventures and chairman of OIS, Dr. Cunningham was able once again to entice both key FDA ophthalmic representatives to participate in an open discussion at a well-attended “Breakfast Breakout” session that kicked off 2015’s OIS@AAO conference in Las Vegas.
Dr. Eydelman opened the session by outlining five key “firsts” that took place within her division over the past year:
- First-in-class device approvals. In April 2015, the KAMRA™ Corneal Inlay from AcuFocus became the first-ever approved corneal inlay; this device is indicated for improvement of near vision in patients with presbyopia. Then, in June 2015, Wicab’s BrainPort® V100 had the honor of receiving the first FDA approval for an oral electronic vision aid to assist profoundly blind patients.
- Shift of premarket data requirements to the postmarket setting. The goal here is to strike the right balance of premarket and postmarket data collection to facilitate timely patient access to important technologies – without compromising patient safety – and the example is the AMO TECNIS® Toric intraocular lens (IOL) that was approved in December 2014.
- Ophthalmic Leap Frog Guidance Document. Designed to promote innovation, this new kind of guidance applies to emerging product classes where there are currently only one or zero such products on the market. In this regard, Dr. Eydelman noted that her division has seen an influx of microinvasive glaucoma surgery (MIGS devices, which prompted FDA to write a Leap Frog Guidance for MIGS.
- AAO Task Force Consensus Statements Focusing on Device Innovation. The AAO Task Force recently published a series of Draft Consensus Statements aimed at expediting innovation of premium IOLs. Included are recommendations for newly defined “Extended Depth of Focus” (EDOF) IOLs.
- Collaboration between FDA and Bi-Coastal Centers of Excellence in Regulatory Science and Innovation. One goal here was to determine patient preferences in glaucoma treatment with a focus on MIGS devices (at Johns Hopkins), whereas a second objective was to develop patient-reported outcome measures (PROM) assessing health-related quality of life in mild to moderate glaucoma patients (at UCSF/Stanford). The American Glaucoma Society is actively supporting this effort.
The ensuing Q&A revolved around a critical medical interest group that is gaining increased attention in today’s health care environment: patients. In particular, patient compliance and patient-directed outcome measurements were discussed.
Dr. Eydelman explained that the overall nature of medical devices as compared with drugs results in patient compliance being less of an issue for devices. However, compliance can indeed be a concern for removable devices (e.g., contact lenses and their appropriate cleaning regimen). In these instances, the agency and practitioners need to combine and coordinate efforts to educate patients.
Turning to the drug side of the FDA, Dr. Chambers stressed that the agency is charged with looking at end results – if a study’s endpoint is IOP lowering, then IOP lowering is what must be shown. And in granting marketing approval the FDA does not take into account compliance issues that may or may not be encountered in a real-world setting. The law is quite clear in stating that a product must do what its label says it does, Dr. Chambers explained.