Published in Pipeline

What to keep an eye on in 2026

Alex Delaney-Gesing

This is editorially independent content
9 min read

Day 2 of the new year is officially underway, and with it, our editorial team has prepared a rundown on what’s to come in the eyecare space over the next 12 months.

From anticipated clinical data and potential new drug submissions (NDA) to FDA approvals and commercial product launches—here’s a few key developments to look forward to.

Where to start?

With anticipated redemption for two clinical candidates the FDA rejected in 2025:

  • Sydnexis’s SYD-101 (low-dose atropine sulfate ophthalmic solution) eye drop with the potential to become the first pharmaceutical option for progressive myopia in pediatric patients aged 3 to 14.
    • The FDA rejected its NDA in October due to its clinical data not supporting the effectiveness of low-dose atropine in pediatric myopia.
    • The plan: To address the federal agency’s issues and (potentially) resubmit its NDA—but no timeframe as of yet.
  • Aldeyra Therapeutics’s reproxalap, a small-molecule modulator of reactive aldehyde species (RASP) formulated as an eye drop for the treatment of dry eye disease (DED)

And while we’re on the subject of resubmissions …

That brings us to Biologic License Applications (BLAs) that were rejected by the FDA earlier in 2025, but have since been resubmitted and are now awaiting a response.

Among these: Viridian Therapeutics, Inc. and Outlook Therapeutics, Inc.—who both resubmitted their BLAs in November.

What to know about their respective clinical candidates:

  • Viridian’s veligrotug (veli) is an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody that reduces the tissue swelling and inflammation associated with thyroid eye disease (TED) via an intravenous (IV) injection.
  • Outlook’s ONS (bevacizumab-vikg) is an IVT-administered injection that neutralizes vascular endothelial growth factor (VEGF) biologic activity to treat wet age-related macular degeneration (AMD).

And looking ahead … let’s talk more PDUFAs.

There are quite a few in the pipeline—but we’ll start with Tenpoint Therapeutics.

Its candidate: BRIMOCHOL Preservative Free (PF), a proprietary, pupil-modulating and fixed-dose, once-daily eye drop with two FDA-approved formulations: brimonidine tartrate and carbachol.

  • Its proposed indication: presbyopia
    • Learn how it creates and sustains a “pinhole effect” by reducing the pupil size for sharpened vision.

What’s the latest update on this?

As we previously reported, the FDA accepted Tenpoint’s NDA submission in June 2025 to review its clinical research on BRIMOCHOL PF’s safety and effectiveness.

And when is its PDUFA date?

The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of Jan. 28, 2026.

Alrighty, what’s next?

Next up is Chiesi Global Rare Diseases, a business unit of the Italian biopharmaceutical company Chiesi Group.

Its asset: Idebenone—a synthetic analogue of ubiquinone formulated as an oral tablet.

  • Its proposed indication: Leber Hereditary Optic Neuropathy (LHON), which leads to acute central vision loss.

Take note: Idebenone has already received regulatory approval—under the brand name Raxone—by the European Medicines Agency (EMA) to treat visual impairment among LHON adult and pediatric patients.

And in the United States?

The FDA accepted and granted priority review—translating to an accelerated 6-month review process instead of the standard 10 months— to idebenone’s NDA package in September 2025.

This submission: Was reportedly based on clinical data from a combination of phase and phase 4 clinical trials—see here and here for a rundown on those findings.

  • As for its PDUFA: That would be Feb. 28, 2026

Let’s move on to … Nanoscope?

Yup! Nanoscope Therapeutics actually began a rolling BLA submission for its investigational gene-agnostic optogenetic therapy in July 2025.

The asset: Multi-characteristic opsin (MCO)-010.

  • Its proposed indication: retinitis pigmentosa (RP)

What it is: An ambient-light activatable MCO optogenetic agent formulated to reprogram healthy retina cells into photosensitive cells via a single, in-office, intravitreal (IVT) injection (with no need for genetic testing).

So what’s with this rolling BLA submission?

This is thanks to MCO-010’s Fast Track designation (among others) from the FDA, enabling Nanoscope to submit its BLA in stages.

See here for a look at some of the clinical data included in this package—as well as additional 3-year, phase 2b/3 data reported just in the last few months.

And when is it expected to be fully submitted?

Nanoscope previously shared a target of “early 2026.”

Speaking of early 2026 … isn’t Ocular Therapeutix targeting that timeframe as well?

Indeed it is. The company announced plans to advance AXPAXLI (OTX-TKI), its wet AMD candidate, toward regulatory approval in the new year.

A quick recap on AXPAXLI:

  • What it is: An investigational, bioresorbable hydrogel intravitreal (IVT) implant
  • Its purpose: To continuously deliver axitinib as a 9-to-12-month target release (translating to just 1 to 2 injections per year) for wet AMD.
    • Click here for details on how this is powered by the company’s patented platform for sustained-release drug delivery.

And what’s the plan for the candidate?

First will be Ocular Therapeutix’s release of phase 3 data from its SOL-1 study in Q1 2026.

Then: The company expects these anticipated positive findings to support a wet AMD-indicated NDA submission, which it intends to submit “shortly after” the data release.

Duly noted … and any other future submissions to be aware of?

For sure. Specifically, Nicox has reported its intent to submit an NDA for its NCX 470 0.1% in early 2026.

As for what to know about this asset, we’ll start with:

  • What it is: A novel nitric oxide (NO)-donating bimatoprost formulation (eye drop)
  • Its proposed indication: To lower intraocular pressure (IOP in open-angle glaucoma (OAG) and ocular hypertensive (OHT) patients

And what’s the latest clinical data on it?

Promising, positive phase 3 results from the phase 3 Mont Blanc and Denali trials, which evaluated its superior IOP-lowering effect versus latanoprost.

  • See here and here for details on the Mont Blanc and Denali results, respectively.

To note: Datasets from both studies are expected to be included in this future NDA submission, as they demonstrated NCX 470’s safety and efficacy—a requirement for them to be included in the NDA package (which requires no further data).

And when’s that ETA on its NDA submission?

(Tentatively) by the second half (H2) of 2026.

See here for details on Nicox’s NCX 470 commercialization plans in the U.S. and other global territories (hint: it involves a partnership with Kowa Company Ltd.).

Speaking of H2 …

Another drug candidate is expected to make headway toward regulatory approval—this time for meibomian gland dysfunction (MGD).

  • What it is: Azura Ophthalmics Ltd.’s AZR-MD-001 (selenium sulfide ointment).
  • What it does: Via topical application to the surface of the lower eyelid, it restores meibomian gland function, improves tear stability, and reduces symptoms associated with DED.

And what’s the 2026 expectation?

Azura is anticipating the release of long-term safety phase 3 data in Q1 2026 from one of three clinical studies (two phase 3 and one phase 2) whose data have been confirmed by the FDA to support “regulatory efficacy requirements for approvability” of the ointment.

  • See here for a look at prior phase 2 data on AZR-MD-001 for MGD.

As for this NDA submission: That’s expected in H2 2026.

This can't be everything we’re anticipating this year, can it?

Of course not. It’s just a glance at what’s to come (see what we did there?).

Check back at our website, follow us on LinkedIn and Instagram, and don’t forget to subscribe to our weekly newsletter for all the latest updates and developments to come over the next 12 months!

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