OR WAIT null SECS
By Peter Sonnenreich, MA, and John Jesitus, MA
Chicago-A favorable regulatory and investment climate in ophthalmology means that ophthalmologists and patients can expect more expeditious drug and device approvals in 2013 and beyond, said speakers at the recent Ophthalmology Innovation Summit (OIS) held here.
For starters, experts expect recent FDA changes to streamline the drug and device approval process. In late 2012, as part of the FDA Safety and Innovation Act (FDASIA), Congress authorized the Medical Device User Fee Amendment III and the Prescription Drug User Fee Amendment. Both aim to increase FDA funding and personnel to provide more timely reviews of drug and device applications. These measures expire in October 2017.
The FDA also has pledged to make specific changes in areas ranging from staff levels and training to how it communicates with applicants-from pre-submission to post-marketing.
One executive who welcomes the changes is Edward Peterson, president and chief executive officer (CEO) of AcuFocus Inc., which is developing a device (Kamra) to increase depth of focus for patients with presbyopia. Meetings between AcuFocus representatives and the FDA are always very productive, he said. Afterward, he said, "You know exactly what you need to do."
However, he said, scheduling a meeting can take 3 to 5 months.
"With more staff, the agency could host more meetings with industry throughout the process,” he said. “This kind of interaction between the industry and the FDA has the potential to improve the process dramatically."
For example, Peterson said, being able to work collaboratively throughout the investigational device exemption and premarket approval submission process with the FDA’s input upfront would improve the quality of submissions and could further expedite the process.
Also, simply increasing the number of FDA reviewers likely will help the agency process applications faster, he added.
In 2012, said Malvina Eydelman, MD, director of the FDA’s Division of Ophthalmic, Neurologic, and Ear Nose and Throat Devices, received 1,441 submissions, including 447 for ophthalmic devices.
Capturing venture capital
Overall, the FDA changes aim to increase the accountability, predictability and transparency of the review process. Achieving these goals will reduce the risk related to FDA submissions and increase the availability of venture capital in ophthalmology and other specialties, said William Link, PhD, a Versant Ventures managing director who specializes in early-stage medical device investments.
Quinton Oswald, CEO of SARcode Bioscience, added that how potential investors view early-stage drug and device companies hinges largely on the predictability of the FDA.
To that end, “For the FDA to provide earlier and more frequent feedback is very helpful for a company like mine,” he said.
Moreover, Dr. Link and Oswald said they hope that increased funding especially will benefit the FDA device review process-because its funding has fallen in recent years, while its complexity and duration have increased. Compared with drug approvals, Oswald noted, the device process seemed to be “a moving target. Every time people would try to satisfy the FDA, something else-such as a need for additional data-popped up.”
It's too soon to tell whether beefier budgets are facilitating smoother device reviews, Dr. Link said. But already, as several of his companies interact with Dr. Eydelman and her staff, "I'm seeing improved responsiveness," he noted.
Since the FDASIA passed, added Richard L. Lindstrom, MD, "The FDA and its representatives are much more available, responsive and helpful in giving guidance to companies who are trying to create clinical trials, or nearing submission of clinical trial data. We are starting to see some more rapid approvals as well."
As founder and attending surgeon at Minnesota Eye Consultants, and adjunct clinical professor emeritus at the University of Minnesota, Department of Ophthalmology, Dr. Lindstrom frequently consults with early-stage ophthalmology companies.
Untapped ophthalmic opportunities
Regarding financing, large pharmaceutical and device companies, along with public shareholders, would like more access to ophthalmology, added Anthony J. Gibney, managing director, East Coast biopharma at Leerink Swann LLC.
It offers healthy profit margins, the ability to launch drugs effectively with smaller sales forces, and a generally consistent FDA evaluation process, which builds confidence in clinical trial data, he explained.
Accordingly, he said, the receptivity of investors, merger/acquisition experts and even regulators to ophthalmology creates very fertile ground for innovation.
The global drug and medical device market is expanding modestly, with sales growth expected to match the rate of population increase (15.8%) through 2017, Gibney said.
Meanwhile, ophthalmology’s share of this market will grow from 2% presently to 2.3%, he predicted.
Ophthalmology’s modest market share highlights the specialty's many untapped opportunities-namely, diseases that remain untreatable because treatments have not been approved or, in some cases, even attempted, Gibney said. Such indications one day may dwarf wet age-related macular degeneration (AMD), which represents nearly half of ophthalmology sales, he said, because wet AMD treatments are largely biologics.
Regarding stock activity, he said, "It was a breakout year for Regeneron, which posted a 166% jump in its stock price in 2012. The vast majority of the growth came from [aflibercept]."
Elsewhere, he said, the most commercially relevant data to emerge in 2012 involved Fovista (Ophthotech), which, in combination with ranibizumab (Lucentis, Genentech) showed significantly better visual gain over ranibizumab alone in a phase IIb study in wet AMD. Fovista's active ingredient blocks platelet-derived growth factor-B.
Among products under development, SAR 1118 (SARcode) successfully completed a phase III dry eye study. Conversely, voclosporin (Luveniq, Lux Biosciences) failed in its phase III trial for noninfectious uveitis.OT
Dr. Lindstrom is medical director of Sightpath Medical and Refractec, and chief medical officer of TLCVision. He serves on the board of directors of AcuFocus, Encore, Refractec, RevitalVision, TearLab, TLCVision, and Wavetec.
In addition to being president and CEO of AcuFocus, Peterson serves on the board of directors for Accelerated Vision Group and AqueSys.
Dr. Link's Versant investments include AcuFocus, Cameron Health, ForSight, Glaukos, Inogen, LenSx, NeoVista, Neurotech Pharmaceuticals, Rox Medical, Second Sight, and Wavetec.