An exciting new drug for dry eye disease will soon be available
Several novel and greatly needed ocular surface disease agents are showing promise in FDA trials, projected to be approved for clinic use as soon as next summer. Now is the time to begin educating patients about these therapies so they’ll be prepared to revisit your clinic once the new treatments are approved and available. In my opinion, there is no patient education software that does a better job than Rendia to explain the eye’s anatomy to patients and potential outcomes of various treatment options.
Here’s a look at a groundbreaking new drug for dry eye disease and how I use Rendia’s Exam Mode with my patients to show how the treatment works.
NOV03: Perfluorohexyloctane (Bausch + Lomb)
This novel agent (pronounced “novo three”) may be the first drug approved for the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). Studies have shown that MGD is present in 86% of DED. Unlike most current eye drops which come in 30-50 uL doses, a dose of NOV03 is only 12 uL. The low volume, combined with its mechanism of action, are the keys to success.
NOV03 would be the first drug approved for the most common cause of dry eye disease: meibomian gland dysfunction.
NOV03 has been shown to replace the lipid layer more closely and last longer than other eye drops. This is especially helpful in achieving proper lipid layer thickness (LLT) in DED patients. Recall that the LLT is 0.01 microns, or the equivalent scale of dental floss to a football field (with the mucoaqueous layer being on the scale of a 100-yard football field). If the LLT is too thick, it could blur vision. If LLT is too thin, it evaporates and leads to DED. NOV03 appears to replace the lipid layer and lasts 4-6 hours after a single dose. Compare that to most therapeutic drops, which are measurable on the eye for only about 3-5 minutes.
FDA trials show better results with NOV03 than previous DED drugs
FDA clinical trial results showed that NOV03 met both primary efficacy endpoints: statistical improvement in total corneal fluorescein staining (p<0.001) and improvement in eye dryness score (using a visual analog scale), (P<0.001) compared to hypotonic saline at day 57. Hypotonic saline is often a base for artificial tears, showing that NOV03 is much more than an artificial tear and will be a prescription medication should it get approval in 2023. More impressive is the fact that these two endpoints were met as soon as two weeks — and in only two Phase 3 pivotal trials. In comparison, previous DED drugs took four or more studies to achieve this feat.
NOV03 met two primary efficacy endpoints after just two weeks and two Phase 3 trials, compared to previous DED drugs that required four or more studies to achieve this feat.
The NOV03 eye drop is very comfortable; the only adverse event that occurred in more than 1% of patients was mild blepharitis. No patients in the study reported blurred vision. The drug is preservative-free and was dosed q.i.d. (4 times a day) in the study.
How Exam Mode aids doctor-patient conversations about DED and MGD
NOV03 will give hope to patients struggling with evaporative DED or MGD, as the first therapeutic likely to be approved by the FDA that will target the cause of most DED — which is MGD —rather than treating the downstream inflammation. But getting patients to understand their condition, and how to treat it, requires effective patient education. Rendia’s Exam Mode makes it easy.
NOV03 will give hope to patients struggling with evaporative DED or MGD – provided that you properly educate patients. Rendia’s Exam Mode is ideal.
I use the anatomical illustrations to point out the vertical meibomian glands in the eyelids, informing patients that these glands provide the oil layer that keeps tears on the eye. Under the functions tab, select “tear flow” and you can demonstrate the tears flowing from the meibomian glands. Then explain that if these glands aren’t working well, patients may experience burning or stinging, blurring or fluctuating vision, and tearing as the other tear glands try to compensate for the lack of oil and dryness.
Exam Mode POVs can help show patients how these symptoms may impact their vision, and what occurs with DED. Start by selecting “dry eye” in the conditions drop-down menu to show patients the lack of tears and increased redness associated with DED. The POV is right below the animation showing the common symptoms of this condition. This is an efficient and effective way to educate dry eye patients, setting the stage for a discussion about the new NOV03 eye drop pending FDA approval in summer 2023.
In the meantime, I can discuss various existing treatments, from hydrating compresses to in-office treatments for MGD. All can be found in Rendia under the “treatments” tab. By educating patients on current and future treatments for their condition, you establish yourself as an expert in your field and the go-to provider for patients.
Want to know more about setting up your dry eye patients for success? Download our Dry Eye eBook to learn about how patient education plays a crucial role in treating your dry eye patients.