The year of 2024 has been jam-packed with major FDA approvals and clearances, commercial product launches, and—of course—a number of legal run-ins and callouts from the FDA (see here for a brief look).
Out of all these updates, though, which caught the eye (pun intended) of our readers the most?
We give you: Our top 10 Glance-ified news coverage.
Let’s start with #10.
Refractive tech startup TEClens gets J&J investment
- Published: July 29, 2024
- Players involved:
- Johnson & Johnson
- TECLens
Your rundown: Johnson & Johnson co-led Series A funding of TEClens, a New York City-based private medical device manufacturing company with a refractive surgery focus.
Specifically: The startup is looking to develop corneal cross-linking (CXL) technology to potentially address keratoconus, progressive pediatric myopia, and elective vision correction procedures.
Key to this: Its proprietary tech, dubbed “Quantitative Corneal CXL (qCXL), intended to reshape the cornea for three primary corrections via a device applied directly to the eye’s scleral surface that then releases patterned ultraviolet light to "crosslink" specific zones of the cornea.
- Learn about it here—including why clinicians should consider adding this 30-minute treatment to their practice.
Moving on to #9…
Optase’s Allegro Eye Drops targets environmental irritant relief
- Published: Oct. 11, 2024
- Player involved:
- Optase
Your rundown: Published in the midst of ocular allergy season, this coverage did a deep dive into one treatment option for patients suffering from irritated and dry eyes: OPTASE Allegro Eye Drops.
The over-the-counter (OTC), preservative-free lubricant features a unique formula of ingredients (including ectoin, a naturally-occurring molecule that thrives in harsh/dry environmental conditions) that work to significantly improve ocular symptoms.
Providing rapid symptom relief within 30 seconds, the product is clinical data-backed and expertly recommended (watch this video).
#8
FDA sends warning letter to Regener-Eyes for cGMP violations, unapproved new drugs
- Published: Sept. 17, 2024
- Players involved:
- FDA
- Regener-Eyes (Regenerative Processing Plant, LLC)
Your rundown: Regenerative Processing Plant, LLC (RPP), manufacturer of the Regener-Eyes ophthalmic products, received a warning letter from the FDA following a June 2023 inspection that uncovered significant violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for pharmaceuticals.
- Take note: This wasn’t our first coverage of RPP’s run-in with the federal agency.
The gist of this warning letter: Extended to RPP’s Regener-Eyes PRO and LITE products being in violation of the Federal Food Drug & Cosmetic (FD&C) Act by being unapproved new drugs that were illegally introduced into the commercial space as well as being misbranded.
Now lucky #7.
Konan Medical launches objectiveFIELD visual field analyzer
- Published: Nov. 12, 2024
- Player involved:
- Konan Medical
Your rundown: Konan Medical USA debuted a new addition to its ophthalmic diagnostic device portfolio with the U.S. commercial launch of the objectiveFIELD Analyzer.
Marketed as the “first and only truly objective perimeter FDA 510(k)-cleared to assess visual field abnormalities,” the device uses pupillary responses and utilizes the multifocal pupillographic objective perimetry (mf-POP, to save your breath) method.
As for the test itself: Both 30° and 15° exams are conducted bilaterally over the course of either 90 seconds or 7 minutes for both eyes (depending on which test protocol is selected).
- See how it compares to traditional standard automated perimetry (SAP).
And #6?
FTC sends claim forms in LasikPlus provider settlement to consumers
- Published: Feb. 22, 2024
- Players involved:
- Federal Trade Commission (FTC)
- LCA-Vision Inc.
- LASIKPlus
Your rundown: Earlier this year, the FTC notified consumers who may have been victim to LCA-Vision’s deceptive “bait-and-switch” advertising, in which promos falsely offered vision correction procedures for as low as $250 before actually quoting patients as much as $2,295 per eye. Read up on this.
- Quick refresh: The Ohio-based LCA-Vision operated its business under one of the country’s largest LASIK providers: LASIKPlus.
And since this coverage: In October 2024, the FTC followed through on its initial notification to consumers by sending 12,000+ refund payments totaling $1.1 million to those who were impacted by this advertising. Our coverage here.
#5.
FDA issues warning against unapproved B+L copycat eye drops
- Published: Feb. 2, 2024
- Players involved:
- FDA
- Shantou Cross-border Premium Products E-Commerce Co. Ltd.
- Bausch + Lomb (indirectly)
Your rundown: Following the “year of eye drop recalls,” the FDA advised consumers against purchasing or using three “copycat” eye drop products mimicking Bausch + Lomb’s LUMIFY (brimonidine tartrate ophthalmic solution) 0.025% drops due to the potential risk for infection.
Those drops included South Moon, REBRIGHT, and FiVFIVO—all manufactured by Chinese-based companies—and were referred to as unapproved products sold online and claiming to treat ocular conditions like glaucoma, cataracts, presbyopia, and ocular hypertension (OHT).
- See how these copycats differ from LUMIFY
The risk for infection: Two of the three drops were found to be contaminated with bacteria that could result in an antibiotic-resistant infection.
#4.
Eye safety tips you need to know ahead of the solar eclipse
- Published: March 27, 2024
- Players involved:
- Bausch + Lomb’s Jill Saxon, OD (executive director of professional strategy)
- Glance President Jaclyn Garlich, OD, FAAO
Your rundown: Ahead of the much anticipated April 8 solar eclipse, Dr. Garlich spoke with B+ L’s Saxon on the best clinical advice for safely viewing one of the year’s biggest solar events—including the importance of educating patients on how to protect their eye health (and the risks if they don’t).
With expert tips from both the optometric and ophthalmic academies, check out this video for all the details (hey, it’s never too early to prep for the next total solar eclipse … in 2044).
#3
Johnson & Johnson unveils TECNIS Odyssey presbyopia-correcting IOL
- Published: April 5, 2024
- Player involved:
- Johnson & Johnson
Your rundown: J&J debuted the TECNIS Odyssey, a new presbyopia-correcting (PC) intraocular lens (IOL), ahead of the 2024 American Society of Cataract and Refractive Surgery (ASCRS) annual meeting.
Joining an already robust product portfolio of monofocal and PC lenses, this premium IOL provides full vision range (both near and distance) to provide reduced night vision symptoms plus top-quality contrast and low-light performance.
Key to its design: J&J’s TECNIS Synergy technology, which blends light rays to enable them to focus on the eye’s back surface—a stark contrast to conventional monofocal IOLs.
- See the clinical data on it.
#2
FTC adds final compliance-targeted updates to Eyeglass Rule
- Published: June 28, 2024
- Players involved:
- FTC
- Eye care professionals (ECPs)
Your rundown: Just over 1.5 years after first announcing an amendment proposal to the Ophthalmic Practice Rules (better known as the Eyeglass Rule) to promote competition and consumer choice, the Federal Trade Commission (FTC) reported its final changes.
- See here for the complete list of those.
The goal with these changes: Ideally, to increase compliance due to the rule’s mandate for ECPs to give patients a free copy of their prescription after a refractive exam.
And why make the changes now, you ask? Among a few reasons, the FTC noted an increase in warning letters issued to ECPs following consumers’ complaints of violations to the long-held rule.
- Side note: Check out our later coverage on this from September 2024, when the updated Eyeglass Rule officially took effect.
At last … now #1.
InMode investors asked to join class action lawsuit
- Published: Feb. 19, 2024
- Players involved:
- InMode Ltd.
- InMode investors
- Robbins Geller Rudman & Dowd LLP (Robbins Geller)
Your rundown: After filing a class action lawsuit against InMode Ltd., San Diego, California-based law firm Robbins Geller called on investors to join as plaintiffs in accusing the company and certain executives of violating the Securities Exchange Act.
- InMode background: The Israeli-based radio frequency-based tech manufacturer of minimally-invasive procedures and surgical procedures originally launched Envision, a U.S.-based ophthalmic platform consisting of a nonsurgical device for delivering precision treatments.
The allegations: Over a 1.5-year time period, InMode and its executives made false and/or misleading statements and/or failed to disclose a number of product-related sales discount tactics—as well as FDA regulation violations.
- Plus: The lawsuit alleged that customers were threatened with legal action after filing complaints over the company’s devices and sales tactics, ultimately leading to its stock prices crashing.
For more legal coverage of the eyecare space, head over to Glance.
Yikes .. anything else we should take away from this year?
Check out our 2024 FDA approvals and commercial product launch rundowns.