Your rundown on 2024 FDA approvals

In just the blink of an eye, it’s already nearing the close of yet another jam-packed year of clinical developments in optometry and ophthalmology.

But before we kick off 2025, we’d be remiss if we didn’t give our readers a rundown on the array of drug approvals, commercializations, and latest pipeline news.

Today’s topic: FDA approvals.

When discussing last year’s FDA approvals, we took it specialty by specialty. This year, however, we’re giving the top approvals and clearances to you in chronological order. So sit back and direct your eyeballs to our rundown of 2024’s latest additions to the eyecare space.

Where to start?

Backtracking to January 2024, we’ll begin with Bausch + Lomb’s FDA approval of the TENEO Excimer Laser Platform.

What it is: The surgical platform is designed for use during laser-assisted keratomileusis (LASIK) surgery on patients diagnosed with myopia and myopic astigmatism (see the exact criteria).

• Its claim to fame: The company is marketing the TENEO as the first excimer platform to be FDA-approved in nearly 20 years as well as the smallest excimer laser in the U.S.

What makes it unique: The laser features two record-setting components:

• Advanced eye-tracker (operating at 1,740 Hz—currently the fastest of all flying spot excimer lasers in the U.S.)
• High-speed (500 Hz) laser operating at an ablation time of an estimated 1.2 seconds per diopter—also currently the fastest of all similar lasers in the country.

Is this available yet? Indeed it is. Reach out to request this for your practice.

Next up?

In March, Formosa Pharmaceuticals, Inc. and AimMax Therapeutix, Inc. received FDA approval for clobetasol propionate ophthalmic suspension 0.05% (APP13007).

• Note: While these companies developed the APP13007, Eyenovia owns the U.S. exclusive rights.

What it is: A novel aqueous nanosuspension formulation containing corticosteroid clobetasol propionate (0.05%) and indicated to treat postoperative inflammation and pain following ocular surgery.

• Its dosing schedule: Twice daily (BID) for 14 days

As a bonus: Clobetasol propionate was actually commercially launched to the U.S. market in September 2024.

Moving on ...

Fast forward to May 2024: AEYE Health was granted FDA clearance for the AEYE Diagnostic Screening (AEYE-DS), its fully autonomous artificial intelligence (AI) diagnostic screening system for diabetic retinopathy (DR).

What it does: The AEYE-DS is a portable system designed to detect more-than-mild DR in diabetes patients (aged 22+) with no prior DR diagnosis by capturing one image per eye of a patient in just 1 minute via a desktop camera and using AI to analyze the data.

• Most notably: This was the first-ever clearance of an autonomous and portable technology of this type.

And interestingly: The point-of-care screening system was previously cleared by the FDA in 2022 for AI-based DR diagnostic screening, making it commercially available with a tabletop imaging device (the difference between the two: portability).

Speaking of imaging …

It’s really a perfect segue to our next addition: Notal Vision Inc.’s FDA De Novo marketing authorization for the SCANLY Home OCT (optical coherence tomography) device.

What it is: A self-operated and comprehensive remote patient monitoring service for patients with wet age-related macular degeneration (AMD) that captures spectral-domain (SD-)OCT images in less than 1 minute per eye.

• Note: While not an exact FDA approval or clearance, per say, a De Novo classification essentially enables a device with no predicate device on the market to be marketed for commercial use.

And to follow this up: Findings from a first-of-its-kind prospective clinical trial supporting the SCANLY for wet AMD management were later published in RETINA.

Let’s get into FDA clearances …

While not necessarily a first-time clearance, New World Medical, Inc.’s Kahook Dual Blade (KDB) Glide was granted a 501(k) expanded indication for a new procedure.

• About the product: Originally FDA-registered in 2020, the KDB Glide is used for advanced excisional goniotomy to enable precise excision of disease trabecular meshwork (TM).

The new indication: Reducing IOP in primary open-angle glaucoma (POAG) patients during cataract surgery or a standalone procedure.

And while we’re on the subject of surgery …

The FDA also granted 510(k) clearance to Alcon, Inc. for two technologies in its UNITY surgical equipment portfolio:

• UNITY Vitreoretinal Cataract System (VCS)
  • Indicated for use during anterior segment (phacoemulsification and cataract removal) and posterior segment (vitreoretinal) ophthalmic surgery
• UNITY Cataract System (CS)
  • Indicated for use with compatible devices only during anterior segment (phaco and cataract removal) ophthalmic surgery

Quick refresh on this 510(k) clearance: This is reserved for Class II medical devices deemed to be comparable to an already-legally-marketed device.

Let’s move on … didn’t VABYSMO receive another approval?

Yes, it did! While Genentech, a member of the Roche Group, was originally granted FDA approval for VABYSMO (faricimab-svoa) in November 2022 and October 2023, this year’s new approval was for a new version of the retinal disease-targeting, anti-vascular endothelial growth factor (VEGF) therapeutic.

Specifically: VABYSMO Prefilled Syringe (PFS)

• What it is: A 6.0 mg single-dose PFS of faricimab-svoa delivered exactly the same as standard VABYSMO vials—just in an alternative, ready-to-use format
  • Its indications: Similar to VABYSMO, the PFS version is also indicated for:
    • Wet AMD
    • Diabetic macular edema (DME)
    • Retinal vein occlusion (RVO)

I noticed there haven’t been any IOL approvals yet …

Think again. Just in the last couple of months, Bausch + Lomb Corporation reported that the FDA had approved its enVista Envy intraocular lens (IOL).

About this IOL: Joining the company’s enVISTA IOL product line of monofocal and toric hydrophobic acrylic IOLs, the Envy IOL provides a continuous full range of vision and dysphotopsia tolerance among cataract patients.

• Specifically, it simultaneously corrects:
  • Presbyopia
  • Astigmatism

And key to its performance: An array of proprietary technologies and unique features, including the use of Active Sync Optic intelligent energy distribution (for optimizing vision in all light conditions).

As for commercial availability: B+L reported that while a limited release of the IOL is ongoing, a broader rollout is expected in the new year.

That’s exciting! Anything else we missed?

One more honorable mention for you! We’d be remiss if we didn’t note the relatively recent approval of LumiThera Inc.’s Valeda Light Delivery System (LDS).

What it is: A non-invasive treatment, photobiomodulation (PBM), and light-emitting diode (LED) system that uses multiple wavelengths: 590 nm, 660 nm, and 850 nm.

• What it does: The Valeda LDS transfers a non-coherent, eye-safe column of light to deliver treatment to the eye (via either an open or closed eyelid and a non-dilated eye).
  • The duration: Less than 5 minutes

See our coverage for more details on this—including an exclusive interview with LumiThera President Clark Tedford as he discusses the mechanics of the system.

That’s quite an update on approvals.

Indeed it is. And to think: we haven’t even gotten started on commercial product launches.

But we’ll save that for another time…