Somehow, some way, 12 months have flown by (in the blink of an eye) and we’re mere days away from ringing in 2026. But before we kick off the new year, we’d be remiss if we didn’t give our readers a rundown on the array of drug approvals, commercializations, and pipeline news that rocked eyecare in 2025.
Today’s topic: FDA approvals and commercial product launches.
So sit back and direct your eyeballs to our rundown of 2025’s newcomers to the eyecare space.
- And keep in mind: This is just a highlights version—see here for all product news from this year and the plethora of approvals/commercial launches we’ve covered.
Where shall we begin?
In chronological order, of course.
First up: We’re taking it back to February with the clearance of EssilorLuxottica’s Nuance Audio Glasses.
What it is: Over-the-counter (OTC), prescription-based smart glasses embedded with hearing aids for adult patients with mild-to-moderate hearing loss in both ears (or difficulty understanding speech in noisy environments).
Its unique components:
- Embedded “invisible” hearing technology with customizable, directional capabilities
- Plano Transitions lenses (GenS) with light-responsive treatment, darkening, and ultraviolet (UV) blocking abilities
See here for more details on its design and components (and here for additional information).
And did these glasses launch to the U.S. commercial market yet?
Yes! In April 2025.
The FDA-cleared glasses are reportedly available at LensCrafters, Target Optical, Pearle Vision, and other authorized optical and audiology practices and retailers.
- See here for pricing options.
What other products made a splash in February?
A major addition from Lumenis: the commercial launch of OptiLIFT.
What it is: A proprietary-based dynamic muscle stimulation technology (DMSt) designed to tone facial muscles to treat lower lid laxity and impaired blinking of the periorbital area.
- Why DMSt makes a difference: This noninvasive treatment uses electrical impulses to trigger nerve signals that activate facial muscles—resulting in tightening and toning of the underlying facial structure.
See here for a look at the device’s technology and optional radiofrequency (RF) microneedling upgrade.
Any others?
On more notable mention for February: Blinkjoy’s launch of the Blinkjoy Rechargeable Heat Mask.
What to know about it: This twice-daily heat mask incorporates advanced heating technology, lightweight performance-knit fabric, and plush padding to offer wearers soothing heat therapy for dry or irritated eyes.
- Details on its customization features can be found here.
- And see here for ocular benefits (including increased tear film stability).
For pricing options, check here.
Moving on … didn’t Bausch + Lomb have a launch in March?
Indeed! That would be Arise, a cloud-based orthokeratology (ortho-k) lens fitting system.
Its purpose: To operate as a user-friendly system that streamlines the ortho-k lens design process.
- How: By syncing directly with diagnostic tools (specifically topographers) that capture 3D images of the eye to generate precise lens designs to treat myopia—without needing a fitting set.
- See here for a breakdown of this process, which utilizes advanced algorithms.
And check out these details on its custom lens design options (which, take note, are based on the first FDA-approved ortho-k lens design with toric peripheral curves).
Alrighty, what’s next?
Also in March: The FDA’s approval of Neurotech Pharmaceuticals’s groundbreaking ENCELTO (revakinagenetaroretcel-lwey).
- Its claim to fame: ENCELTO is the first-ever approved treatment for the treatment of macular telangiectasia type 2 (MacTel).
As for what it is: An allogeneic encapsulated cell-based gene therapy designed as an ocular implant that delivers therapeutic doses of ciliary neurotrophic factor (CNTF) into the retina to slow disease progression (of MacTel).
Notably: The therapeutic is administered via a surgical intravitreal (IVT) implantation
- See here for more details on its dosage and usage guidelines.
And is it commercially available in the U.S. yet?
Yes … the first implant procedure of ENCELTO was announced in August 2025.
The procedure was conducted by Charles C. Wykoff, MD, PhD, of Retina Consultants of Texas in Houston, Texas.
And since then: ENCELTO was assigned a permanent J-code by the Centers for Medicare & Medicaid Services (CMS).
Next up: Wasn’t there presbyopia news?
There was (in April)! Specifically: The commercial launch of Orasis Pharmaceuticals’ QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% following its October 2023 FDA approval.
- About it: This prescription-based, preservative-free (PF) eye drop is indicated for the treatment of adult presbyopia.
What makes it unique: Its EyeQ Formulation creates a “pinhole effect” that increases the depth of focus and ability to focus on near objects while simultaneously minimizing the risk of diffraction.
- See here for details on its flexible dosing schedule and prescribing information.
- And click here to head over to its product website.
And we’d be remiss if we didn’t ask about dry eye news …
Alcon would certainly have something to say about that, as the FDA approved its first prescription-based pharmaceutical in May: TRYPTYR (acoltremon ophthalmic solution) 0.003%.
- Its indication: For the treatment of the signs and symptoms of dry eye disease (DED)
As for what makes it unique: The eye drop is a first-in-class agonist of the TRPM8 receptor that leads to increased basal natural tear production (read up on this mechanism of action).
- This is a notable difference from other dry eye prescription therapies, which typically focus on inflammation reduction or tear film stabilization.
Sounds like a game-changer. Is it commercially available yet?
Yes, actually. The eye drop launched in July—just 2 months after its regulatory approval.
- See here for details on cost and savings.
And as a bonus: Since TRYPTYR’s commercial debut, Alcon actually released even more supporting clinical data on its superior tear response—this time from a phase 3b. Check it out.
Back track to June for a moment—Wasn’t there a new contact lens?
Good memory! And yes, there was. In fact, Johnson & Johnson made quite the splash with the commercial launch of its new ACUVUE OASYS Max 1-Day Multifocal (MF) contact lens for Astigmatism during the American Optometric Association’s (AOA) annual Optometry’s Meeting.
The significance: This latest ACUVUE OASYS lens is marketed as the first and only disposable contact lens for patients with both astigmatism and presbyopia.
Specifically: As a single-use MF toric lens, it’s designed to provide all-day comfort with crisp, clear, and stable vision at all distances and lighting conditions (plus, a non-MF version is also available).
- See the plethora of unique technologies embedded in the lens (including for blink stabilization, pupil optimization, and reduced tear evaporation).
Now what’s next?
Lenz Therapeutics’ VIZZ (aceclidine ophthalmic solution 1.44%).
Its claim to fame: This was approved as the first and only aceclidine-based eye drop for the treatment of adult presbyopia (see here for our coverage).
What else to know: VIZZ is a PF, single-use, once-daily drop that offers a “pinhole” effect to improve near vision and prevent a myopic shift.
- See here for its full prescribing information
- Fun fact: It also works for patients who previously underwent LASIK or cataract surgery (though an ECP should be consulted beforehand).
And this drop is already commercially available, right?
As of Oct. 1—yes! Check out all those details here (including where to find it).
Let’s talk virtual reality.
You must be referring to the MedTech company VirtuaLens and the debut of its flagship product: the Immersive IOL (intraocular lens) Simulator, a first-of-its-kind virtual reality (VR)-base technology.
Focusing on this tech (unless you want to learn about this new company, in which case—see here):
- The Immersive IOL Simulator offers patients an in-office, lens type comparison to explore how different lens options may enhance their vision in various contexts and situations.
- How: Via a 3-to-5-minute, VR headset-simulated, customized experience
See here for how this process works (and for which target parents)—as well as how to add this to your practice.
What else?
We’d be remiss if we didn’t mention another company debut (or rather, rebrand) coupled with a new product launch announced in September.
Specifically: Newton (formerly Neurolens) and its commercial launch of the Sequel lens.
- See here for a rundown on the company’s rebranding.
What to know about Sequel: This single-vision lens is designed as an alternative for progressive wearers who don’t necessarily present as symptomatic and also spend long hours in front of digital screens.
- Sequel also utilizes the company’s new proprietary Convergence Boost Lens Technology, which improves visual comfort and clarity.
- See here for more on these lenses (including its availability through VSP).
Next up?
That would be EssilorLuxottica’s Essilor Stellest spectacle lenses, which were granted FDA marketing authorization in late September.
Their claim to fame: These are the first-ever FDA market-authorized spectacles clinically proven to slow myopia progression among pediatric patients (aged 6 to 12).
What to know about them: Intended for daily use, they’re designed with:
- Highly Spherical Lenslet Target (HALT) technology (to slow myopia progression)
- A 9mm, single-vision optical zone (to correct myopia refractive error)
And importantly: The FDA described the spectacles’ lenses as a lower risk device (compared to contact lenses) with no adverse events typically associated with contact lens use.
Moving on … to a major FDA approval, right?
Yes! Just days after Academy, the FDA approved Glaukos Corporation’s cornea collagen crosslinking (CXL) iLink therapy:
- Epioxa HD (riboflavin 5’-phosphate ophthalmic solution) / Epioxa (riboflavin 5’-phosphate ophthalmic solution) 0.177%,
What to know: This is a novel, oxygen-enriched topical therapeutic designed as an incision-free alternative to traditional CXL procedures for use in epi-on corneal collagen CXL to treat keratoconus in adults and pediatric patients aged 13+.
- See here for details on its novel formulation
- And click here for how this differs from Photrexa (epi-off)
Its claim to fame: Epioxa is the first FDA-approved topical drug for the treatment of keratoconus that doesn’t require removal of the corneal epithelium.
Nice! What else?
Another FDA clearance—and simultaneous commercial availability—of Topcon Healthcare’s OMNIA, a fully automated 4-in-1 ophthalmic testing device.
What to know: This auto kerato-refracto tonometer is a portable and compact tool that integrates four key objective tests: refraction, keratometry, tonometry, and pachymetry.
Included in its features: A one-touch, fully automated user interface with air puff technology, a 360° touch screen rotation, and DICOM compatibility for electronic medical records (EMRs).
- See more about its embedded technology—and did we mention it can capture 20 points of data in less than 1 minute?
Any other approvals (or launches) to be aware of?
Plenty … but we’ll highlight just two more, starting with the commercial launch of Evoq Technologies’ Twilight Dark Adaptometer.
What it is: This FDA-registered, Class I medical device is designed as a smartphone-based portable device for measuring dark adaptation performance for retinal health monitoring
- The kicker: Twilight is built for at-home use (by patients) with remote monitoring and tracking by physicians (though the device can also be used in any clinical setting).
The intent: To streamline the functional vision assessment process and provide early detection of retinal dysfunction for diseases such as AMD, diabetic eye disease, and inherited retinal diseases.
And that last approval?
That would be the FDA’s approval of a new indication and expanded dosing option for Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) injection 8 mg.
What to know:
- This new indication: Macular edema following retinal vein occlusion (RVO)
- And the expanded dosing: An every-4-week dosing option for “some patients who may benefit from resuming this dosing schedule” across all EYLEA HD indications
Get the full rundown on this here.
That’s a pretty impressive run of updates ...
You’re telling me. And that wasn’t even the full list of approvals and launches.
Click here for a look at all our product coverage (and see here for FDA approvals specifically).