FDA greenlights Qlosi for presbyopia in adults. It is hoped the lower dose and preservative-free pilocarpine would lead to reduced side effects, but caution for individuals with retinal conditions.
On October 18, 2023, Orasis Pharmaceuticals announced that the FDA has given approval to Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults.1 This marks a significant milestone, as it's the second medication approved for this prevalent condition following the introduction of Vuity in 2021 in the US.
Presbyopia, also referred to as age-related farsightedness, is a vision issue that plagues a significant portion of older adults worldwide. The prevalence and severity of presbyopia tend to increase with age, impacting up to 85% of individuals aged 40 or older. In 2015, approximately 1.8 billion people worldwide had presbyopia, and this number is expected to peak at around 2.1 billion by 2030. Astonishingly, it's estimated that 94% of those who suffer from significant near vision impairment due to uncorrected presbyopia reside in developing countries.2
The implications of presbyopia extend far beyond the mere inconvenience of reading glasses. For older adults, it poses notable safety concerns. Notably, seniors with visual impairing conditions, including presbyopia, cataracts, glaucoma, and macular degeneration, face a heightened risk of falls.3 Furthermore, research has highlighted that older individuals may increase their fall risk when wearing multifocal glasses while navigating stairs or unfamiliar environments, particularly outside their homes.3
In this article, let's look closely to see how Qlosi works, its effectiveness, and important considerations to bear in mind before choosing this treatment option.
How Qlosi works: a closer look
Qlosi, like Vuity, also contains pilocarpine, a miotic that targets specific eye muscles, causing them to contract. This muscle contraction helps the lens of the eye change shape, creating a pinhole effect and allowing for better focus on nearby objects.1
Qlosi has a lower pilocarpine concentration than Vuity (0.4% vs. 1.25%). This difference has sparked whether Qlosi may have fewer adverse effects than Vuity. Furthermore, Qlosi comes with a preservative-free formulation,1 which may improve drug tolerance and lessen the risk of eye surface inflammation and dry eyes.
Qlosi is a prescription medication and can be used daily or as needed, up to twice per day. It demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, improving near vision without compromising distance or night vision. 1
The effectiveness of Qlosi for presbyopia in clinical studies
The FDA's approval was based on the results of the Phase 3 NEAR-1 and NEAR-2 clinical trials, which involved more than 600 patients. These two trials aimed to evaluate the efficacy and safety of Qlosi fro prebyopia in adults. 1
Both NEAR-1 and NEAR-2 clinical trials met their study primary and key secondary endpoints on Day 8. They demonstrated a statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA) and no loss of 1-line or more in distance visual acuity. 1
As for its safety, only 6.8% and 5.8% of participants experienced treatment-related headaches and instillation site pain, respectively. A 1.3% reported moderate treatment-related adverse events, while all other adverse events were mild. 1
Can you use Qlosi if you have retina conditions?
While Qlosi demonstrated promising results from its trials, not all people are suitable, especially if you have a retinal condition.1 Miotics like pilocarpine have been associated with rare cases of retinal detachment, vitreous detachment, retinal tears, and vitreomacular traction.5, 6, 7Â
According to the product label, a thorough examination of the retina is advised for all patients before starting therapy with Qlosi. If you experience sudden onset flashes of light, floaters, or vision loss, immediate medical attention is necessary. 1
(For more detailed safety information, consult Qlosi's product label.)
When Will Qlosi be available?
Orasis Pharmaceuticals announced with their press release that QLOSI is expected to be commercially available in the United States in the first half of 2024.1
How much will Qlosi cost?
At this moment, the price information is not yet available. However, based on Vuity, these eye drops may not be covered by insurance because they would be considered cosmetic medications. It is likely that Qlosi will be priced similarly or less to Vuity, which is priced at about US $80. Hopefully, with two products competing, the force of the market will drive down the cost. Â
Conclusion
FDA's approval of Qlosi for presbyopia in adults offers people living with the condition a new option. With its lower pilocarpine concentration and preservative-free formulation, it offers a differentiated offering for individuals dealing with presbyopia. However, it's essential to remember, like its predecessor Vuity, Qlosi comes with a warning on retinal detachment. it's crucial to consult with your eye doctor and have a retina examination before starting treatment with Qlosi.
With Qlosi expected to be available in the first half of 2024, let's keep our eyes open, not just for the fine print but for the exciting possibilities it may bring to our lives.
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Other related articles:
A. LASIK for Presbyopia in people with myopia
B. Monovsion for Presbyopia in people with myopia
C. BRIMOCHOL PF eye drop: a new treatment in development for presbyopia
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1. Orasis Pharmaceuticals. "ORASIS PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF QLOSI⢠(PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 0.4% FOR THE TREATMENT OF PRESBYOPIA" Access October 18, 2023. https://www.orasis-pharma.com/orasis-pharmaceuticals-announces-fda-approval-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4-for-the-treatment-of-presbyopia/
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