Novaliq has received FDA clearance for an investigational new drug (IND) application to launch its phase 2 trial on NOV05 for the treatment of non-infectious anterior uveitis (NIAU).
To note: This is reportedly the company’s first IND for the treatment of inner-eye diseases.
Where to start?
As with other ophthalmic topical therapies in Novaliq’s pipeline, NOV05 is based on EyeSol technology.
What it is: A proprietary, preservative- and water-free technology that uses ultrapure semifluorinated alkanes (SFAs).
- What these are: Colorless non-aqueous liquids that improve ocular drug delivery (particularly in cases of dry eye disease, as seen with Novaliq’s FDA-approved VEVYE and MIEBO).
And what advantages come with SFA use?
As the company noted, these:
- Have very low surface tension and viscosity
- Dispense low-volume drops (<12 µL) that do not stimulate blinking or reflex tearing
- Have the same refractive index as water
As such: Products utilizing EyeSol are designed to “spread rapidly over the ocular surface and form a flat, transparent layer that enables clear vision without blurring”— all while also stabilizing and restoring the tear film.
So, with this basis in mind, tell me about NOV05.
NOV05 (tacrolimus in EyeSol, suspension) is formulated as a steroid-free eye drop administered via a targeted, topical delivery of EyeSol.
Its purpose: To control intraocular inflammation (IOI)—notably without the side effects and complications often associated with current forms of NIAU treatment:
- Corticosteroid drops
- Periocular or intraocular corticosteroid injections
- Systemic immunosuppressive agents
Explain the significance of this tacrolimus component.
Tacrolimus is a calcineurin inhibitor that acts as a strong immunosuppressant by reducing activity of the immune system.
- When administered orally, it’s been found to be effective in preventing organ rejection in transplant recipients (as well as for severe plaque psoriasis and ulcerative colitis).
However, as Novaliq noted: The immunosuppressive agent has “low bioavailability in eye tissues … systemic side effects limit its use .. (and) delivery of topical tacrolimus to the tissues inside the eye has not been shown yet.”
- Hence, why the company is looking to evaluate its use for NIAU.
Got it. So what do we know about this upcoming study on NOV05?
Based on prior ocular pharmacokinetic findings, the first-in-human (FIH), proof-of-concept, randomized, double-masked clinical trial (NCT07285070) is dubbed EYETAC.
Its purpose: To evaluate the safety and tolerability of NOV05 as well as its potential dose-dependent clinical anti-inflammatory effect.
- The participants: An estimated 20 patients (aged 18) with active NIAU
- See here for exclusion and inclusion criteria
- The dosings: High-dose and low-dose NOV05, topically administered four times a day (QID)
- The duration: 6 weeks of treatment
And what will be measured?
Just one primary outcome: Ocular and non-ocular adverse events (AEs) over an 8-week period.
And in general: The study will assess the potential dose-dependent clinical anti-inflammatory effect of the eye drop.
What’s the timeframe on this kicking off?
Novaliq expects to initiate the study in Q1 2026 (so sometime between now and March 31).
Lastly: What’s the big-picture outlook on NOV05 and this study?
CEO Christian Roesky, PhD, noted NOV05’s potential to fulfill the current unmet need for IOI control—without associated side effects—among NIAU patients.
“(This phase 2 study) aims to demonstrate a general proof of delivery of active ingredients to the back of the eye tissues using EyeSol—which would allow us to develop multiple topical EyeSol therapies for retina diseases,” he stated.