With the new year upon us, our team is kicking off 2025 by offering a refresh, reminder, or heads up (whatever you want to call it) to our readers on what to keep an eye out for in the coming months.
From product launches to FDA approvals and new data—here’s our rundown.
Where to start?
We’ve got a product launch for you: Nuance Audio by EssilorLuxottica.
- Anticipated timeframe: Q1 2025
About this product: Nuance Audio is a pair of over-the-counter (OTC) glasses equipped with advanced hearing assistance for consumers (aged 18+) with mild to moderate hearing loss.
- Its design: The frames include microphones embedded in the eyeglasses that amplify the sounds a wearer wants to hear based on the direction of their focus.
- See here for details on its lenses—including the optional light responsive Transitions lenses (GenS) and a visual of how the glasses work.
As far as pricing goes: $1,100 (just for the frames)—click here for details.
Anything else in Q1?
Another product launch: Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%.
- Our notes: We last heard from Orasis Pharmaceuticals in October 2024, when the company announced it had secured $78 million in financing to support the U.S. commercial launch of its presbyopia treatment.
Anticipated time frame: Q1 2025.
- About this product: FDA-approved in October 2023, Qlosi is a prescription-based, preservative-free formulation of low-dose (0.4%) pilocarpine.
- Its dosing: Administered up to twice a day (BID) 2 to 3 hours apart following initial instillation.
- See the complete prescribing information.
- Its dosing: Administered up to twice a day (BID) 2 to 3 hours apart following initial instillation.
And keeping with the theme of presbyopia …
Though not a product launch, it’s the next best thing:
Lenz Therapeutics, Inc.’s Prescription Fee Drug User Act (PDUFA) target action date for LNZ100 (1.75% aceclidine), an investigational ophthalmic solution for presbyopia treatment.
- The PDUFA deadline: Aug. 8, 2025
And a brief rundown on LNZ100: This is a preservative-free, single-use, once-daily eye drop formulated with aceclidine, a small-molecule muscarinic acetylcholine receptor agonist (what a mouthful, we know) that can lead to miosis.
- Why miosis is key: This is intended to result in a “pinhole” effect to improve near vision.
As for its clinical data: The phase 3 CLARITY program supported LNZ100’s efficacy in two trials, achieving its primary and secondary near-vision improvement endpoints for each (and see here for additional supporting phase 3 data.
- Its potential: The company has referred to LNZ100 as a “pupil-selective and long-lasting therapeutic option” for presbyopia patients.
Are there any dry eye developments to keep an eye on?
First up: Aldeyra Therapeutics’ recent (re)submission—and the FDA’s acceptance—of its new drug application (NDA) for 0.25% reproxalap ophthalmic solution (known simply as “reproxalap”) for dry eye disease (DED).
- The PDUFA deadline: April 2, 2025
- See here for the controversy behind its original submission
About reproxalap: This is a small-molecule modulator of reactive aldehyde species (RASP), which is a class of molecules usually elevated in ocular and systemic inflammatory diseases.
- Its unique mechanism of action (MOA): Reproxalap’s effects have been found to begin within minutes of topical administration (up to 12 weeks).
The clinical data: The company previously reported it to be “the first investigational drug with pivotal data supportive of acute and chronic activity in reducing DED symptoms.”
- See the findings, including on its efficacy for allergic conjunctivitis (AC), which it’s also in clinical development for.
What else on the dry eye front?
Alcon also has some expected clinical news in regard to its prescription-based DED candidate: AR-15512 (acoltremon ophthalmic solution 0.003%).
But first, a rundown: Originally developed by Aerie Pharmaceuticals, AR-15512 is a topical transient receptor potential melastatin 8 agonist (TRPM8), a cold-sensing receptor for the cornea and eyelid with the potential to relieve symptoms of DED).
The clinical data: Back in November 2024, Alcon reported pivotal data from its phase 3 COMET-2 (NCT05285644) and COMET-3 (NCT05360966) clinical trials.
- Its investigated dosing schedule: One drop in both eyes (BID)
- Note: AR-15512 previously achieved both its primary and secondary endpoints for these trials, with a rapid onset and sustained tear production associated with the asset vs vehicle as early as Day 1 through Day 90.
What to expect in 2025: Positive findings from the phase 3 COMET program recently supported an NDA submission to the FDA—with an anticipated PDFUA target action date of May 30, 2025.
Let’s stick with Alcon … what’s the plan for its new DSLT device?
Great question—and good memory! For reference, it’s now called “The Voyager.”
The company’s rebranded direct selective laser trabeculoplasty (DSLT) device was all the buzz at the 2024 American Academy of Ophthalmology (AAO) annual meeting in October.
- Some background: The Voyager—originally known as The Eagle—was originally developed as the flagship product by Israeli glaucoma surgery company BELKIN Vision before being acquired by Alcon in July 2024.
What it is: A Q-switched, 532 nm-wavelength, frequency-doubled, Nd:YAG laser device designed to provide an automated and non-invasive solution for glaucoma surgery.
- Why it’s a game-changer: It’s the first—and currently only—direct selective-laser trabeculoplasty (DSLT) laser for glaucoma that delivers laser energy through a non-contact approach via the cornea.
What to expect in 2025: With FDA 510(k) clearance already under its belt (figuratively speaking), The Voyager is expected to launch in Q1 2025.
Any other Q1 plans to know about?
Yes! An anticipated PDUFA target action date for Neurotech Pharmaceuticals, Inc’s NT-501 (revakinagene taroretcel), an encapsulated cell therapy (ECT) designed to treat macular telangiectasia type 2 (MacTel),
About this candidate: NT-501 is an ocular implant that utilizes the ECT platform to transport therapeutic doses of ciliary neurotrophic factor (CNTF; which protects against photoreceptor loss) directly into the retina.
- Its goal: Slowing the disease progression of MacTel.
Its regulatory background: In June 2024, the FDA granted priority review for Neurotech’s BLA ahead of the standard 6-month review period—which was later extended to an additional 3 months.
- See our coverage of this, reported in November 2024.
What to expect in 2025: The FDA updated the PDUFA date for NT-501 to March 18.
What’s next?
We also want to call attention to Viridian Therapeutics and its investigational candidate for chronic thyroid eye disease (TED): VRDN-001 (veligrotug).
What it is: An anti-insulin-like-1 receptor (IGF-IR) monoclonal antibody that blocks cell surface receptor activity, resulting in (ideally) a reduction in TED-associated tissue swelling and inflammation.
- Its dosing regimen: Five, 30-minute intravenously-administered infusions (3 weeks apart)
The clinical data thus far: Positive topline findings reported from the phase 3 THRIVE trial, with VRDN-001 meeting both primary and secondary efficacy and safety endpoints for treating active TED.
- See our coverage from September 2024.
What to expect in 2025: When releasing that phase 3 data, Viridian noted plans to submit a Biologics License Application (BLA) to the FDA by the second half (H2) of 2025.
And while we’re on the subject of clinical data …
Adverum Biotechnologies, Inc. is getting ready to kick off a double-masked, randomized phase 3 trial to evaluate its lead asset:
Ixoberogene soroparvovec (Ixo-vec), currently under clinical investigation for the treatment of wet age-related macular degeneration (AMD).
What it is: Ixo-vec is a vectorized aflibercept (an anti-vascular endothelial growth factor [VEGF]) coding sequence controlled by a proprietary expression cassette optimized exclusively for intravitreal (IVT) injection—with the goal of delivering long-term VEGF inhibition.
- To note: This asset is unique in that it incorporates Adverum’s proprietary adeno-associated virus (AAV) transgene vector technology to encode retinal cells and deliver therapeutic proteins through the retina.
The clinical data: See the positive findings from the asset’s long-term, 4-year data that included three key benefits among patients—including an 86% reduction in annualized anti-VEGF injections.
What to expect in 2025: A Q1 launch of the first of two phase 3 trials evaluating Ixo-vec as a 6E10 vg/eye dose among treatment naïve and treatment-experienced wet AMD patients.
- Get a rundown on the study here.
Any other phase 3 news?
For FELIQS, its two lipid oxidation-targeting small molecule-based assets are expected to make strides this year:
Fresh off its FDA Fast Track designation, FELIQS is gearing up to report topline data on FLQ-101, a small molecule under clinical evaluation for preventing retinopathy of prematurity (ROP).
What it is: FLQ-101 and FLQ-104 (the company’s second asset, intended for dry AMD) are lipid modulators designed as a once-daily oral/intravenous solution intended to enhance “the physiologic response of vascularization” within the retina.
- Plus: They’re designed to protect from inflammation and abnormal neovascularization.
- Most notably: FLQ-101 has the potential to become the first preventative treatment for ROP—different from the already-FDA-approved Eylea (Regeneron, Inc.), the first pharmacological treatment.
What to expect in 2025: Aside from an anticipated phase 1b/2 study initiation on FLQ-101 in both the U.S. and Japan, FELIQS has also reported being on track to submit an investigational new drug (IND) application for FLQ-104 for intermediate dry AMD in H2 2025.
Sounds like this is a big year …
Indeed it is. Only time will tell how it stacks up to last year’s FDA approvals and commercial launches…