FDA Calls for Stronger Oversight on Eye Drop Safety

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Belkin Vision’s Glaucoma Laser Device FDA-Approved

Last week, Belkin Vision announced that the FDA granted 510(k) clearance for its Eagle device, a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser for use in performing selective laser trabeculoplasty (SLT).

What makes the Eagle different from other Nd:YAG lasers out there? The company describes the Eagle as the first contactless glaucoma laser, offering an automated, noninvasive solution for SLT procedures. According to Belkin, one of the advantages of the Eagle is that its laser energy is delivered in a noncontact procedure directly through the eye’s limbus into the trabecular meshwork without the need for a gonioscopy lens applied to the ocular surface. Not only that, but the device automatically finds the target location and directly applies the laser treatment sequence, while the automated eye tracker compensates for any eye movement. (Read more here.)

My Two Cents

If the price tag of this device ends up allowing it to be brought into clinics around the country, we could see the Eagle change the paradigm of glaucoma management. As optometrists continue to win the ability to perform SLT procedures across the nation, the Eagle could demonstrate to lawmakers and key decision-makers how technological advances have made the surgical process “noninvasive.” Additionally, the LiGHT Trial’s 6-year data have recently been released, which conclude that, “Selective laser trabeculoplasty is a safe treatment of OAG and OHT, providing better long-term disease control than initial drop therapy, with reduced need for incisional glaucoma and cataract surgery over 6 years.”

OUTSIDE THE LANE

The FDA Has Had Enough of Eye Drop Recalls

Each week, it seems as though we’re hearing about a different eye drop recall or contamination notice. These repeated recalls have drawn attention to the limited powers the United States regulators have to watch over medical products made in overseas facilities.

Recently, the FDA has asked Congress for additional powers, including the ability to mandate drug recalls and require eye drop makers to undergo specific inspection measures before shipping their products to the United States. Industry experts are concerned that these capabilities will do little to protect the public's safety without more staff power and resources for foreign inspections.

“The FDA is not getting its job done regarding drug quality assurance inspections abroad,” said David Ridley of Duke University. “Very few foreign drugmakers have been inspected in the past four years.” According to Ridley, the number of FDA foreign inspections was down 79% in 2022 when compared with data from 2019, and even now, these inspections are far below pre-pandemic levels.

The interest in these foreign inspections stems from the October recall of 2 dozen drop brands after the FDA found cracked floors, barefoot workers, and unsanitary conditions at a Mumbai plant. This site supplied products to CVS, Walmart, and other major retailers.

According to experts, one possible change that could help the eye drop issue would be to require eye drop manufacturers to give at least 6 months' notice before shipping products from a new factory. This would give inspectors time to examine facilities that aren’t currently on their radar. Required recalls are also being advocated for. Although the FDA warned consumers not to use the drops profiled in late October, the products weren’t officially recalled until 3 weeks later.

Additionally, it is believed that more funding is needed for foreign inspectors. Unknown to most consumers and physicians is that most routine, in-person inspections were halted in 2020 and did not resume until 2022. Ridley suggests hiring more overseas inspectors and increasing their salaries to be more competitive. (Read more here.)

My Two Cents

It’s extremely interesting that most overseas manufacturing plant inspections were halted for ~2 years during the pandemic. With no regulation and little to no oversight, it’s not hard to imagine that some bad actors would use that opportunity to release less-than-optimal products. In an effort to protect our nation’s health, the FDA must step up to the plate and hire more competent and ethical foreign inspectors immediately.

CAN YOU RELATE

Working at a large OD/MD practice, one of the things I enjoy most is the opportunity to have lively debates and discourse with my colleagues about the proper way to care for our patients.

One such recent discussion that stuck with me concerned when we should formally recommend cross-linking for a patient who may be right on the cusp of eligibility or already have corneal scarring.

Here’s the situation: A 30-year-old Black female patient presented to us in 2022 with complaints of an ever-increasing astigmatism, stating that she’s “never gotten the correct prescription from any eye doctor.”

Upon examination, she presented with Vogt striae without application of pressure, Munson sign, and extreme inferior thinning, with the right eye substantially more noticeable than the left eye. After extensive education about the disease process, we reviewed the patient’s options in detail, explaining epi-off cross-linking, which would hopefully arrest the development of keratoconus, and scleral lenses, which would not alleviate the disease process, but merely provide her sharper/more functional vision.

Although the patient had central corneal scarring, we formally recommended cross-linking; she, however, decided to wait and see if her eyes worsened. She opted for “contacts and not an invasive surgery.”

Fast forward through a successful contact lens fitting, and the patient returned 1 year later with a substantial increase in steep K and a thinning cornea OD (see images above). She also presented with an increased amount of central corneal scarring.

So, the debate begins. Should we cross-link this patient, who is worsening rapidly and already has central corneal scarring and a thinner cornea than is typically recommended for epi-off cross-linking? (You typically like to see the thinnest area of the cornea > 400 µm.) If we cross-link her, we could induce scarring and permanently reduce her vision, thus creating the need for a corneal transplant. But isn’t the whole point of cross-linking to stabilize the ectatic cornea so that a transplant won’t be necessary?

For these types of cases, do you take the risk and cross-link the patient, knowing that you could induce scar tissue, or do you declare them not a candidate and watch their rapid worsening likely result in the need for a transplant anyway? It’s a challenging situation to be in!