Qlosi™ in Focus - A Novel Formulation, Flexibility, and New Horizons in Presbyopia Treatment

Our 40s and 50s are typically when we reach the height of our abilities, enjoying the greatest freedom to live life to the fullest; however, many of us will experience visual changes that restrict this freedom. “Presbyopia is an unavoidable and irreversible reality we face,” explains Jacob Lang, OD, FAAO. “128 million Americans—nearly 90% of those aged 45 and above—are currently affected;¹ by 2050, an estimated 1.8 billion people will suffer from presbyopia globally.² It takes an emotional toll, leaving patients frustrated and embarrassed, particularly by their increasing reliance on others.”³

However, despite its prevalence, up to a third of presbyopia sufferers do not receive care from eyecare professionals.⁴ “I saw a patient today for an annual eye exam,” Jackie Garlich, OD, FAAO recalls. “Last year, I’d given her a multifocal contact lens, but unbeknownst to me, she hadn’t liked it and had elected to return to her distance-only lenses. It just highlights that our patients may be in this percentage without us knowing.” Part of this may be that, like Dr. Garlich’s patient, the current non-pharmacological treatment options don’t meet every patient’s needs. “Reading glasses have an inconvenience factor,⁵ contact lenses can be intolerably uncomfortable, and the results—and any side-effects—of surgery are irreversible,”⁶ Dr. Lang explains. “Each of these options can be a good fit for patients, but may also require them to make unwanted concessions.” It’s clear that a more flexible and effective presbyopia management method is needed.

Qlosi is the first and only FDA-approved eye drop indicated for presbyopia in adults with EyeQ formulation^TM, which provides more presbyopia management flexibility in a way unlike anything else on the market. At only 0.4%, Qlosi contains the lowest available concentration of pilocarpine^7,8—approximately one-third of that in other formulations. “When treating patients’ eyes, I want to do the least I possibly can to make things better,” explains Dr. Garlich. “This is why we want the smallest effective concentration.” Additionally, Qlosi has a near-neutral pH, which enhances pilocarpine bioavailability, facilitates delivery, and lowers the minimum effective dose required.^7,9-11 It also includes dual lubricating agents (hyaluronic acid and hydroxypropyl methylcellulose) to enhance eye comfort, and further reduces the risk of irritation and progression of other ocular surface diseases by being preservative-free. Ultimately, EyeQ formulation offers more benefit for less pilocarpine.

Although pilocarpine has long been used in eyecare, it’s also been long associated with several side effects that impact tolerability¹²—something EyeQ formulation works to address. Patients taking Qlosi experience incredibly low rates of headaches, visual impairment, conjunctival hyperemia, and blurred vision.¹³ However, Derek Cunningham, OD, FAAO, doesn’t believe practitioners should consider other pilocarpine formulations as direct competitors. “Aside from the active product, there aren’t a lot of similarities between them,” he explains. “On one side, you have pilocarpine glaucoma concentrations, which really line up with all the negatives of pilocarpine we learn about in school, and on the other, there’s Qlosi, which is a completely different animal. When making a product, the majority of research and drug development doesn’t go into the active ingredient, but instead, controlling its behavior. It’s about being selective and poignant with exactly where the patients receive the drug—doing this results in minimization of side effects and less active ingredient being required, like in Qlosi. In this way, it’s more of a designer drug, and it’s for this reason that Qlosi is really outstanding in terms of limiting the occurrence of side effects. I think patients will be pleasantly surprised by this when taking Qlosi.”

“We know that EyeQ formulation contains less pilocarpine and minimizes side effects—but does it actually work?” asks Dr. Garlich.

This was assessed in two identically-designed, Phase 3, randomized controlled clinical trials, NEAR 1 and 2, which had over 600 participants,⁷ half of whom received twice-daily Qlosi for two weeks.¹⁴ On day eight, even just one hour post-first Qlosi dose, 40.1% of patients displayed a three line or more gain in monocular distance-corrected near visual acuity (DCNVA) without a loss of one line in corrected distance visual acuity—at dose two, this percentage rose further to nearly half. “Although this data is good, patients don’t typically walk around with one eye covered—binocular vision provides better real-world insight on how patients might actually be with Qlosi,” says Dr. Garlich. Looking at the summation of functional vision, although 52.9% of patients achieved 20/40 or better monocular vision, 76.2% reached this goal binocularly. And this lasted over time—72.8% of patients still maintained this vision 8 hours later. “This is important because it separates lane vision from functional vision,” Dr. Cunningham explains. “When performing a clinical study, you could show any pupil to be optimal by designing a specific lane test. But that’s not compatible with the real world. We’re looking at making patients’ vision functional without affecting other aspects—that’s what Qlosi is doing here.”

One of the ways in which Qlosi gives patients functional vision is by modulating their pupils to a diameter of 2.0-3.0 mm—striking the balance of keeping focus sharp, preventing chromatic and spherical aberration, which occur as pupil size increases; and allowing enough photons to enter the eye to see at varying light levels, which is restricted as pupil size decreases. This modulation happens within only 20 minutes and is maintained even eight hours after the initial dose.^7,14 And because the brain neuroadapts over time, patients experience continual improvements to their vision—the proportion of patients achieving 20/40 or better DCNVA rose from 74% on day one to 89% on day eight. This is why Dr. Cunningham stresses the importance of patients taking Qlosi twice a day, every day, during their onboarding week.

Developing an effective product is important, but patients need to access it for these benefits to be of use. Here Orasis has taken a number of bold steps to ensure the right patients get Qlosi at the right price. The first is making Qlosi available via BlinkRx and Medvantx. “Although these specialty pharmacies can be a departure from what patients are used to, they give us control over the patient experience, the product, and how it gets to the patient,” Dr Cunningham explains. “As physicians, we’re able to convey to patients the exact price—not going through third-party payers or pharmaceutical insurance plans means that everybody pays the same and knows what they’re paying—and other details with confidence and without having to worry about potential issues occurring. It makes our lives as physicians incredibly easy and lets us advocate on behalf of our patients by bringing them every available option, including the latest technologies, before they’re accessible anywhere else.” Dr Lang agrees, “They’re really an evolution in how we look at pharmacies, especially for a niche like eyecare. It’s a real win.”

The second avenue Orasis has taken, is only making Qlosi available for prescription by eyecare providers. “In the past, when other products launched, the majority of the highest prescribers weren’t eyecare professionals,” Dr Cunningham explains. “Because they were available for any doctor to prescribe, they were given to everyone under the sun—seemingly without even basic knowledge regarding ocular optics.” Because, as he points out, some patients will find more benefit than others. “In the published data, early presbyopes that still had some flexibility within their lenses responded best to Qlosi,” he explains. “An absolute presbyope, who’s likely a little older, will probably respond less well—there may still be some benefit, but it’ll take a little longer to be realized.” Additionally, practitioners should not prescribe this drop to individuals hypersensitive to the active ingredient or any of the excipients, highlighting the need for careful consideration on the part of prescribers when considering any eyecare pharmaceutical—including Qlosi.

For Dr. Garlich, ensuring that patients will at least have had a comprehensive eye exam before being prescribed Qlosi, once again highlights the deliberate approach Orasis has taken. “As mentioned before, when it comes to presbyopia treatment options, not everyone is a great candidate for everything,” she says. “The decision to ensure that non-eyecare professionals don’t prescribe Qlosi is intentional and leaves the decision of whether to prescribe or not, which will affect patients’ eyes, in the hands of the providers who are really going to know which patients will actually benefit—and which won’t. I already have a list of patients that I feel will be a good fit for Qlosi, and I’m really excited to start offering it in my practice.”

For additional information, please visit qlosiECP.com