Ophthalmic Ointment for DED Moving Toward NDA Submission

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Ophthalmic Ointment for DED Moving Toward NDA Submission

After a positive pre-New Drug Application (NDA) meeting with the FDA, Azura Ophthalmics announced that its existing clinical data package for AZR-MD-001, an investigational ophthalmic ointment to treat dry eye disease (DED) linked to meibomian gland dysfunction (MGD), is sufficient to support a planned NDA submission in the second half of 2026.

AZR-MD-001 uses a novel triple mechanism—keratolytic (breaking down keratin plugs), keratostatic (preventing excessive cell buildup), and lipogenic (promoting oil production)—delivered as a twice-weekly nighttime application to the lower eyelid margin. This dosing approach aims to restore gland function, enhance tear stability, and relieve symptoms such as ocular discomfort and contact lens intolerance. The drug’s efficacy was demonstrated in two pivotal phase 3 trials. In CELESTIAL, treatment with AZR-MD-001 led to statistically significant improvements in Meibomian Glands Yielding Liquid Secretion scores and reductions in Ocular Surface Disease Index symptoms. ARIES showed increased comfortable contact lens wear time. Safety profiles from these studies, along with ongoing data from the ASTRO trial (expected in early 2026), indicate excellent tolerability suitable for long-term use, with no major adverse events reported.

The FDA’s positive feedback suggests the well-controlled confirmatory efficacy studies fulfill the approvability criteria for both signs and symptoms of DED. In the company’s press release, Francis Mah, MD, from Scripps Clinic, noted that the therapy’s focus on gland obstruction could be “practice-changing” for addressing an undertreated root cause. As Azura prepares its NDA, AZR-MD-001 positions itself as a differentiated option in the DED market, promising broader access to effective, noninvasive relief for patients worldwide.

My Two Cents

It’s fitting that I get to profile one of the companies and products I am most excited about in one of my last newsletters! I have been watching Azura closely, and this could be the next big revolution in dry eye management and care. The company’s product, AZR-MD-001, makes sense from a physician’s standpoint, and I believe it will also make sense for our patients. Recently, we’ve seen a plethora of FDA approvals in the space that are “practice-changing,” such as Xdemvy (Tarsus), Tryptyr (Alcon), Miebo (Bausch + Lomb), and even Vevye (Harrow), a unique cyclosporine formulation. I am absolutely on board the Azura hype train and can’t wait to see where it takes us!

OUTSIDE THE LANE

Artificial Sweeteners Linked to Cognitive Decline

In a groundbreaking 8-year prospective study published in Neurology, researchers from the University of São Paulo's Department of Preventive Medicine examined the link between low- and no-calorie sweeteners (LNCS) and cognitive decline among Brazilian civil servants. The investigation drew from the Brazilian Longitudinal Study of Adult Health, which analyzed data from 12,772 patients at least 35 years of age (mean age 51.9 years; 54.8% women; 43.2% Black/mixed race) across three time periods (2008–2010, 2012–2014, and 2017–2019). Exclusions ensured data quality by removing incomplete dietary records, extreme caloric intakes, and missing cognitive or covariate information.

Baseline LNCS consumption—encompassing seven types (aspartame, saccharin, acesulfame K, erythritol, xylitol, sorbitol, and tagatose)—was assessed via a Food Frequency Questionnaire, yielding a mean intake of 92.1 mg/day. Cognitive outcomes were derived from z-scores across six tests evaluating verbal fluency, memory, and global cognition. Linear mixed-effects models adjusted for confounders such as age, sex, education, physical activity, and comorbidities to estimate associations with decline rates.

Key findings revealed that higher LNCS intake (top tertile) accelerated cognitive decline, particularly in those younger than 60 years of age; verbal fluency declined faster by β = − 0.040 and global cognition by β = − 0.024. No such effects emerged in participants 60 years of age and older. Individual sweeteners, such as aspartame, saccharin, acesulfame K, erythritol, sorbitol, and xylitol, were implicated in steeper declines across memory and fluency domains. Stratified analyses showed heightened risk declines in verbal fluency and global cognition in non-diabetics and memory/global cognition declines in diabetics.

The discussion posits potential long-term neurotoxic effects from artificial LNCS and sugar alcohols, aligning with broader concerns over ultra-processed foods and dementia risk. Limitations include self-reported diets, attrition bias, and residual confounders, underscoring the observational design’s inability to prove causality. Nonetheless, conclusions urge caution in LNCS use, especially for younger adults and diabetics, advocating for mechanistic research and policy reevaluation to safeguard cognitive health amid rising artificial sweetener consumption.

My Two Cents

These artificial sugars are in everything, and the fact that we’re seeing verbal fluency and global cognition scores drop significantly in patients who consume more LNCS is scary. It really does underscore the need to know exactly what you are putting in your body. Eating clean has never been more critical, and it should be a focus for everyone!

On a related note, I’m glad that Stevia is nowhere to be found on this list, as it’s what is present in Dry Eye Drink, and we were very careful about its inclusion.

CAN YOU RELATE

Life is far too short to not do the things you look forward to. As the days of Significant Findings dwindle, I’d like to share some of the things I am MOST excited about regarding the future of eye care, notably dry eye care!

Of course, I am excited for Azura Ophthalmics’ new ointment for MGD. This could be a significant shift in how many of us treat dry eye. Kudos to them for having their ducks in a row regarding the approval process. Staying in the MGD/eyelid space, it will be fascinating to see how Sight Sciences navigates the potential insurance reimbursement for its Tear Care device. This could bring MGD care to the masses and be a boon for patient satisfaction and clinical growth.

At Williamson Eye Center, we’re bringing in the new epi-on crosslinking (CXL) system, Epoxia (Glaukos). Although I’m not sure about the coverage, it may be faster and less abrasive for the patient than the current epi-on treatment. My rockstar local Glaukos rep, Lance Ranlett, has been on top of getting us all the necessary information, and it seems to be a go for us! I’ll be interested to see how we incorporate epi-on CXL for patients who aren’t good candidates for epi-OFF CXL. One thing is for sure: With reps like Lance, we’re going to be well-armed with the correct info and processes.

Also, all that bragging about Lance should be a gentle reminder of just how valuable our reps are! Yes, I know they often seem to show up at the most inopportune times and can annoy staff; however, they are there to provide you with the most up-to-date information and keep you informed (and obviously sell something). Please do yourself a favor and carve out some time for them. Let them know the best way for them to connect with you, whether that’s over lunch or dinner—just something. Give them your time, and you’ll be richly rewarded! 

I’m also excited about myopia management spectacles. The new Stellest lens (Essilor) is an absolute game-changer (remember, I can’t stand that term). It will be fascinating to see who Essilor targets and how it plans to educate the optometry masses about the product.

Interventional glaucoma will keep growing, and our practice has fully embraced it. It has really become a mindset that makes sense! Rather than using drops that can rough up the ocular surface or be misused or forgotten, shoot a laser into the trabecular meshwork and do the work for the patient. Better yet, hit them with an iDose (Glaukos) or a Durysta (Abbvie). Take the treatment out of your patient’s hands, literally.

Lastly, we’re expecting a few other FDA approvals in 2026. Brimochol PF (Tenpoint Therapeutics), another presbyopia drop, should be getting approved. This one I haven’t heard much about. A generic formulation of bimatoprost 0.01% should be hitting the shelves as well. Will we finally see reproxalap (Aldeyra Therapeutics) for dry eye cross the finish line? I sure hope so! There should also be a few approvals in the macular degeneration space that our friends in retina are probably quite excited about!

What about you? What are you most excited about in 2026?

QUOTE

"Life moves pretty fast. If you don't stop and look around once in a while, you could miss it."

— Ferris Bueller