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FDA announces medical device approval changes

AAO says changes could increase consumer costs of devices.

By Robert Stoneback, associate editor

Anticipated changes to the FDA’s method of approving medical devices could result in increased prices, according to an AAO representative.

The 510(k) premarket application (PMA) process allowed new devices an accelerated path to market so long as they were substantially equivalent to an older FDA-approved device. In ophthalmology, these devices typically include diagnostic tools and lasers.

A “MODERNIZED FRAMEWORK”

“We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” leaders of the FDA recently announced.

“We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices. In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976”. (To read the FDA’s statement, visit http://bit.ly/2Qz7Tin .)

FDA spokesperson Allison Hunt stated that such 510k modernizations would apply to submissions generally, not just to one class of devices. There is not yet a timeline for the changes to go into effect, Ms. Hunt continued, but updates are expected in the coming months. The FDA plans to call its new approach to the 510(k) process the “Safety and Performance Based Pathway,” and will issue final guidance for it in early 2019.

A “MODERNIZED FRAMEWORK”

David Glasser, MD, clinical spokesperson for the AAO, says the FDA’s plan to alter the current approval method of new medical devices by the 510(k) PMA process would create an increased barrier to entry for such products. It could delay the approval process, and manufacturers would transfer increased costs onto the purchaser, he adds. The changes “could discourage innovation if manufacturers don’t see an acceptable return on investment,” he says.

Intraocular devices, including IOLs and minimally invasive glaucoma surgery, or MIGS, implants, would not be affected by the changes, according to Dr. Glasser; they are considered Class III devices by the FDA, and their PMA process is more similar to that of drugs.

REPORT FROM THE ICIJ

A journalistic investigation on medical device safety testing around the world, led by the International Consortium of Investigative Journalists (ICIJ), was published earlier in November.

As part of its reporting, the ICIJ analyzed 5.4 million “adverse event” reports filed to the FDA over the past decade; its analysis found that “medical devices that broke, misfired, corroded, ruptured or otherwise malfunctioned after implantation or use” were linked to more than 1.7 million injuries and nearly 83,000 deaths during that time. To read that report, visit http://bit.ly/2PlgqAB . OM

Dextenza approved by FDA for treatment of post-surgical ocular pain

Ocular Therapeutix received FDA-approval for Dextenza (dexamethasone ophthalmic insert) 0.4mg, the first intracanalicular insert for drug delivery. Dextenza is intended to treat post-surgical ocular pain and lasts up to 30 days with a single administration.

According to the company, Dextenza can potentially replace a complex eye drop regimen that would normally require up to 70 topical ocular steroid drops.

The FDA approval was based on a demonstration of efficacy and safety in two randomized, vehicle-controlled Phase 3 studies. In the studies, a statistically significant higher incidence of subjects were pain-free at day 8 post-cataract surgery, as compared to a control group. Safety was also tested in a third randomized, vehicle-controlled Phase 2 study.

Ocular Therapeutix also submitted an application for transitional pass-through payment status and, at press time, intended to submit an application for a J-code.

Retina therapies make news at AAO

AMD, NPDR and uveitic macular edema drugs continue toward U.S. approval.

By René Luthe, senior editor

They’re not here quite yet, but new therapies are in sight for U.S. ophthalmologists treating retinal diseases such as wet AMD and nonproliferative diabetic retinopathy, according to data presented at the AAO 2018 meeting in Chicago. Read on for the latest from the respective clinical trials.

HAWK AND HARRIER

Phase 3 results from year two (96 weeks) for brolucizumab (RTH258, Novartis) showed the treatment for wet AMD met its primary endpoint of noninferiority vs. aflibercept (Eylea, Regeneron) in BCVA and exhibited superiority in key retinal outcomes at year one, while maintaining robust visual gains in year two.

These new data were based on pre-specified secondary endpoints from the large-scale HAWK and HARRIER trials. Relative to aflibercept, 24% of brolucizumab 6-mg patients with wet AMD had intraretinal fluid and/or sub-retinal fluid at week 96 vs. 37% for aflibercept in HAWK, and 24% vs. 39% in HARRIER. Of the brolucizumab 6-mg patients who successfully completed year one on a 12-week dosing interval, 82% in HAWK and 75% in HARRIER were maintained on a 12-week dosing interval in year two. In both studies, brolucizumab was comparable to aflibercept with the overall incidence of adverse events balanced across all treatment groups.

To learn more, go to tinyurl.com/y7cn6bs4 .

STAIRWAY

One-year data from Genentech’s Phase 2 STAIRWAY study confirms earlier projections that a 6-mg dose of Genentech’s bispecific anti-VEGF/anti-Ang2 faricimab (formerly RG7716) delivered every 16 weeks can, on average, provide as good or better vision gains than Lucentis (ranibizumab; Genentech) administered every four weeks. Patients in the STAIRWAY study were treated with either faricimab 6 mg every 12 weeks or every 16 weeks, or ranibizumab 0.5 mg every four weeks.

After 52 weeks of treatment, average acuity gains for each group were:

  • +11.4 letters with faricimab 16-week dosing
  • +10.1 letters with faricimab 12-week dosing
  • +9.6 letters with ranibizumab four-week dosing

With this new data, faricimab becomes the first investigational treatment for wet AMD to achieve confirmed 16-week dosing for the majority of patients in a clinical trial.

To learn more, go to tinyurl.com/y7wxfhd7 .

PANORAMA

Regeneron’s Phase 3, 402-patient PANORAMA trial evaluating Eylea (aflibercept) in patients with moderately severe and severe nonproliferative diabetic retinopathy met its 52-week primary endpoint and key secondary endpoints. On the primary endpoint, 80% and 65% of patients receiving Eylea on an every eight- and every 16-week interval respectively (after an initial monthly dosing period) experienced a 2-step or more improvement from baseline on the Diabetic Retinopathy Severity Scale vs. 15% of sham injection patients.

The two key secondary endpoints, reported for the first time and indicating the need for early intervention, achieved statistical significance. Treatment with Eylea reduced vision-threatening complications by 82% to 85% and the development of center-involved diabetic macular edema by 68% to 74% compared with sham injection.

To learn more, go to tinyurl.com/y7qufm8f .

PEACHTREE

PEACHTREE was Clearside Biomedical’s pivotal Phase 3 trial of Xipere, its proprietary suspension of the corticosteroid triamcinolone acetonide in patients with uveitic macular edema. At week 24, 40.9% of patients with baseline scores of 2+ vitreous haze based on the Standardization of Uveitis Nomenclature (SUN) scale experienced resolution in the Xipere arm, compared to 0% of patients in the sham procedure arm.

Also, in the Xipere arm, 68% of patients with any baseline level of vitreous haze, 72% of patients with anterior chamber cell inflammation and 74% of patients with anterior chamber flare had their inflammation resolve, compared to 23%, 17% and 20% for the sham arm, respectively.

Resolution was defined as a score of 0 on the applicable SUN scale, implying no measurable inflammation was present.

To learn more, go to tinyurl.com/y7ny8rn2 . OM

Dexycu and Avedro formulations receive permanent J-codes

The Centers for Medicare and Medicaid Services (CMS) assigned a permanent J-code to EyePoint Pharmaceuticals’ Dexycu and to Avedro for two Photrexa formulations. The J-codes for Dexycu and the Avedro formulations became effective at the start of 2019.

Dexycu is a single-dose, sustained-release, intracameral steroid for the treatment of postoperative inflammation; it uses the company’s Verisome extended-release drug delivery technology. EyePoint Pharmaceuticals expects to launch Dexycu in the first half of 2019. The J-code, J1095, will replace the drug’s previous C-code (C9034, which became effective on Oct. 1.

The company retains transitional pass-through status for Dexycu from CMS for approximately three years.

Avedro was issued the J-code J2787 for its formulations for Photrexa (riboflavin 5’-phosphate ophthalmic solution) and Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution). Photrexa and Photrexa Viscous are the only FDA-approved drugs used in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

Photrexa and Photrexa Viscous are indicated for use with the KXL system for corneal crosslinking. A list of private payer insurance companies providing coverage for corneal cross-linking can be found at www.livingwithkeratoconus.com .

QUICK BITS

Coburn Technologies introduced a new portable slit lamp, the SK-LS-1B. The battery-powered lamp is capable of hand-held operation, allowing users to examine patients who don’t have the ability to sit comfortably at a traditional slit lamp. The SK-LS-1B also features a maximum illumination angle of 60° and the ability to connect with an iPhone to use for capturing images.

Centenary Institute (Sydney, Australia) reported the development of a new drug, CD5-2, which could be used to treat diabetic retinopathy patients. CD5-2, developed in collaboration with Danish researchers, has been used in mouse models to mend damaged blood retinal barriers and reduce vascular leakage. The researchers are currently raising funds for clinical trials.

2018 OWL Awards presented at AAO

Winners awarded for advancing diversity in ophthalmology leadership.

OWL: Advancing Diversity in Leadership, an organization based on driving innovation and patient care by advancing diversity in leadership, announced the winners of the 2018 OWL Awards at the organization’s Signature Event, held Oct. 28 during the AAO annual meeting. OWL presents the awards each year to those who best exemplify the organization’s core values.

The OWL Awards winners were:

  • Rising Star Award – Jennifer Loh, MD, board-certified comprehensive ophthalmologist practicing in the south Miami area. OWL’s Rising Star Award “honors an individual who is an emerging leader in ophthalmology, in his/her early or mid-career who demonstrates high potential for making an impact in the profession.”
  • Visionary Leader Award – Allison Shuren, partner & co-chair of the Life Sciences and Healthcare Regulatory Group at the law firm of Arnold & Porter. OWL’s Visionary Leader Award honors “those who have paved the way for diversity in their field through significant achievement and demonstrate leadership in their field through their careers.”
  • Catalyst Award – Brad Fundingsland, president of The Fundingsland Group, which drives medical education through large-scale evidence-based programming. OWL’s Catalyst Award “honors an individual who has contributed significantly to helping others advance their careers in eye care and demonstrates leadership in supporting the advancement of diversity.”

During the event, Robert Dempsey, group vice president and head of Global Ophthalmics Franchise for Shire, and Aylin Kilic, MD, a refractive and cataract surgeon and associate professor ophthalmology at Medipol University in Istanbul, shared their presentation, “Perspectives on International Leadership.” Michael Onuscheck, president and head of global surgical franchise for Alcon, interviewed the pair.

For more information on OWL: Advancing Diversity in Leadership, visit www.owlsite.org . OM