A New Standard of Care in the Wings?

HOT TOPIC

Oculis recently announced positive top line results from the phase 3 OPTIMIZE trial of its novel OCS-01 eye drop, a once-daily, high-concentration, preservative-free, topical Optireach formulation of dexamethasone for the treatment of inflammation and pain following ocular surgery.

The OPTIMIZE trial is a double-blind, placebo-controlled study conducted in 25 sites across the United States in which 241 patients were randomly assigned 1:1 to receive either the OCS-10 eye drop (n = 119) or vehicle (n = 122) for 14 days following cataract surgery. The trial met both primary efficacy endpoints: the absence of inflammation on day 15 and the absence of pain on day 4. In addition, OCS-01 was well tolerated with a favorable safety profile, notably with no meaningful difference in IOP between the treatment groups.

If approved, Oculis believes that OCS-01 has the potential to become a new standard of care and the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.

OUTSIDE THE LANE

Smoke Gets in Your Eyes …

Wildfires in Canada this year have been the worst on record, with strong winds routinely pushing the smoke across the entire country and into many parts of the United States. In fact, my home state of Michigan and entire regions of the Midwest were under air quality advisories, with many people, including my parents, being strongly encouraged to stay inside.

Some Canadian eye doctors have had more patients report irritating eyes, most notably on days that were incredibly hazy due to the wildfire. As the massive wildfires become more common, these doctors, and other eye health experts around the globe say we need to do more to study the long-term effects of smoke on the human eye.

According to Marisa Sit, MD, FRCS(C), of Toronto, “There’s particulate matter, volatile organic compounds” — “these are things [in the smoke] that can irritate our eyes.” The symptoms that these issues cause are many of the same that allergic conjunctivitis is known for: dry, itchy, painful, watery, and gritty eyes.

Although there appears to be a dearth of studies that examine the effects of these particulates on the human eye, doctors hypothesize that studies conducted with other, similar pollutants can help us draw some hypothesis of their effect. The article highlights one “similar pollutant” of cigarette smoke and its propensity to be a risk factor for macular degeneration, as well as “increased cataracts.”

My Two Cents

I’m not sure about the article’s comment about the wildfire smoke causing an increase in cataracts or macular degeneration; however, it does make perfect sense that it’s causing an increase in ocular surface issues mimicking allergic conjunctivitis. What’s the best way to treat this? Are there any Canadian or Midwest eye docs out there who can share what has seemed to help their patients? Do you pound it hard with a steroid drop such as Lotemax (Bausch + Lomb) use an antihistamine, such as Zerviate (Santen) or Lastacaft (Allergan), or is the tried-and-true preservative-free artificial tear (chilled, of course) the best option?

CAN YOU RELATE

Medications for Demodex mites and meibomian gland disease, and yet another new cyclosporine has been approved over the past few weeks. I remember when I graduated optometry school way back in 2013, one of the biggest complaints that optometrists had during my rotations was that there were so few options to treat patients with ocular surface disease—and they were right. We didn’t have many options. In fact, it was basically Restasis (Allergan) or bust for many patients, if they didn’t want to use OTC drops—with preservatives (ewwww!). Well, the free market demanded more treatments for dry eyes, and we’re starting to see that come to fruition.

In the past few weeks (and months), Tarsus Pharmaceuticals received an early FDA approval for Xdemvy, the first treatment for Demodex blepharitis; Bausch + Lomb received approval for Miebo (also an early approved), the first prescription eye drop that directly targets tear evaporation; and Novaliq received approval for Vevye, a water-free, preservative-free 0.1% cyclosporine-based product for the treatment of the signs and symptoms of dry eye disease. (Harrow has since acquired Vevye from Novaliq.)

It remains to be seen how well these products work for our patients, but to say that I’m excited about these new approvals is an understatement. To have not one, but two drops that are the first and only in their class may signal the start of a “golden age” of dry eye care. As these drops gain traction and become available, I can’t wait to share my experience using them with you, and hopefully report that their functionality lives up to the hype and excitement they have generated!

QUOTE OF THE WEEK

“Do not wait to strike till the iron is hot; but make it hot by striking.”

—William Butler Yeats