Pipeline drug AZR-MD-001 Phase 2 trial results published

Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial

S. Watson et al, The Ocular Surface, July 2023

245 patients participated in this MGD drug study at 29 different sites. Patients applied the drug or vehicle to the lower eyelid twice weekly. Primary endpoints were met at month 3.

Results: AZR-MD-001 0.5% (n = 82 patients) treatment resulted in significant improvements in MGYLS score, with patients experiencing an average increase from baseline of 4.2 and 2.4 open glands secreting meibum for the drug and vehicle, respectively (p < 0.001) and from baseline a mean OSDI total score improvement of 7.3 and 3.8 for the drug and vehicle, respectively (p < 0.05). Most TEAEs were mild and transient, with 3 serious adverse events (SAEs) reported with AZR-MD-001 (none related to study drug).

Study: Dry eye clinical practice patterns of UK optometrists

Dry eye clinical practice patterns of UK optometrists

R. Casemore et al, Contact Lens & Anterior Eye, July 2023

131 optometrists in the UK were surveyed about their dry eye practice.

Sixty percent of respondents reported that they believed their patients were satisfied/managed with artificial tear alone

It would be very interesting to hear from the patients of those 60%. Are they in fact satisfied/managed with artificial tear alone?

Conclusions: Although dry eye disease was perceived to be an important condition, opinions varied widely regarding knowledge and confidence in diagnosis and management. Involvement in an extended service did not alter patient management. However, an increase in therapeutic management and the employment of a stepwise approach to management has been identified.

No seasonal dry eye symptom differences in Oslo, Norway

Seasonal variations in presenting symptoms and signs of dry eye disease in Norway (J. R. Eidet et al, Scientific Reports, December 2022)

Signs and symptoms of DED generally did not correlate with weather report data….

Neither dry eye severity level nor dry eye symptoms differ between seasons in Oslo, Norway.

Sodium hyaluronate drops after cataract surgery

The effect of sodium hyaluronate on tear film stability in patients with dry eye syndrome after cataract surgery (Nan Chen et al, Graefes Archives of Clinical and Experimental Ophthalmology, Nov 2022)

Conclusions: In the early stage after phacoemulsification, the stability of the tear film is reduced. Adding sodium hyaluronate eye drops can restore tear film structure and improve corneal surface regularity, and a 0.3% solution of sodium hyaluronate eye drops is more effective than a 0.1% solution.

This abstract caught my eye partly because they studied the effect of two different HA (sodium hyalurate) concentrations in eye drops - 0.3% and 0.1%. Those aren’t the only major differences between the various HA drops on the market, but concentration certainly is an important factor.

Frustratingly, in the US, we cannot readily learn the HA concentration in most over-the-counter eye drops because the FDA-mandated labeling for OTC drops does not allow HA to be listed as an active ingredient. We hope this will eventually change. Meantime, we try to keep up to date information about these concentrations by asking the manufacturers.

Study: Another analysis of DREAM study re Omega 3s and 5 subtypes of dry eye

Dry Eye Subtypes in the Dry Eye Assessment and Management (DREAM) Study: A Latent Profile Analysis (Translational Vision Science & Technology, Nov 2022, Kimberley Yu et al)

Nobody was happy about the DREAM study saying that Omega 3s are not more effective than placebo. But, it did, and it’s been written about extensively. This most recent paper says that they looked into five different dry eye subtypes, and even when they broke the DREAM study data down for each type individually, Omega 3 still wasn’t better than the placebo used in the study.

Conclusions: Five clinically meaningful DED subtypes differed significantly in demographics, symptoms, signs, and systemic disease associations. Omega-3 was not significantly more effective than placebo for any subtype.

Study: Dry eye risk associated with obstructive sleep apnea

Association between poor sleep quality and an increased risk of dry eye disease in patients with obstructive sleep apnea syndrome (Frontiers in Medicine, Oct 2022, Ki Pu et al)

OSA, especially the severe stage OSA, was related to an increased risk of DED. Also, sleep quality was correlated with the onset of both OSA and DED, where poor sleep quality revealed a relationship between OSA and the risk of DED

Study: Autologous serum tear storage requirements to remain effective

Time and Temperature Stability of TGF-β1, EGF and IGF-1 in 20% and 100% Human Serum (Folia biologica, 2022, K. Jirsova et al)

Autologous Serum 101 - how does it work? Growth factors are a key part.

The concentration and stability of various growth factors in ASEDs is determinative for their efficiency.

So they studied the temperatures required to maintain this concentration and stability. The temperatures they studied were 4-8, -20, -80 and -156 °C.

This is a rather timely topic given Dry Eye Foundation’s ongoing concerns about illegally marketed (and commercially manufactured) biologic eye drops Regener-Eyes and StimulEyes. Historically, these eye drops have been marketed for their proteins - cytokines, chemokines and growth factors. But these eye drops are stored at room temperature.

If biologics can remain effective when stored at room temperature, why aren’t autologous serum eye drops stored at room temp too? And why didn’t these study authors at least add a room temperature option to their study for comparison?

Simple - there was no point. No one in the scientific world imagines that autologous serum will be effective if it is not kept frozen or refrigerated.

So our question for the provider community is this:

Unfortunately, what many physicians seem to be forgetting is that proteins are the biologic components from which we expect therapeutic benefit, and those proteins require very specific cold storage in order to stay intact.

You can’t just bottle up biologic materials, set them on the shelf, sell them for inordinate amounts of money and expect them to help people (other than through placebo effect).

See Dr. Brown’s presentations on Sludge for more information.

Study: "Dry eye" has high impact on daily living amongst GvHD patients

Patient-reported symptom burden and impact on daily activities in chronic graft-versus-host disease (Cancer Medicine, November 2022, Jingbo et al)

165 qualifying GvHD patients were surveyed about their symptom burden and ability to perform activities of daily living.

There are limited patient-reported data concerning symptom burden and effects on activities of daily living (ADL).

Yes! This is understudied and under-appreciated in dry eye more broadly. It is also the focus of large 480-patient community survey’s section on “Quality of Life” (see mydryeyedata.org for more).

So here are some of their key results:

44% of respondents considered "dry eye" the most burdensome symptom. Almost half of respondents (n = 73 [44.2%]) rated their overall quality of life (QoL) as poor. Participants reported a detrimental impact of symptoms on ADL, including basic activities (eg, eating, personal hygiene, dressing).

And their conclusions:

Conclusions: Survey respondents self-reported high chronic GVHD symptom burden and felt that their symptoms severely interfered with physical function and ADL. Effective strategies to mitigate chronic GVHD symptoms are needed to improve QoL among HSCT survivors.