Eyedolatry: qlosi study data

Qlosi: New Eye Drop to Improve Near Vision

Qlosi, a new eye drop, is now available to address near vision decline as we age. This is great new for humanity because birthdays affect everybody. Presbyopia is just a normal birthday related change, no different than wrinkles or white hair. Inside our eye we have a lens that works just like a lens in a camera; our eye muscles move this lens in and out to adjust our focus between long distance and up close. Well from the day we are born, the lens inside our eye is one of the only body parts that never stops growing. It’s like a little tree trunk, laying down layers year after year. As those layers add up, the lens is getting thicker, and thicker, and thicker every year, and eventually (around age 40), it’s getting so thick that our eye muscles are having a hard time moving that thing. Our muscles aren’t losing any strength, but our lens is like a little rock in there with all that layering; it eventually just won’t budge no matter how hard our eye muscles work. And guess what, the lens just keeps getting thicker and thicker and cloudier with each passing year, and this is the same process that causes a cataract to develop in our sixties or seventies.

How do you know when presbyopia hits? You’ll experience difficulty adjusting your focus from far away to up close, blurry vision with up close tasks, or really tired eyes when reading or computer use. Many of my patients notice their vision seems even worse in low light condition because the same muscles – the ciliary muscles- that control the lens inside the eye to adjust focus for near vision are also working to constricting your pupil in bright light. Some people start noticing trouble adjusting their focus in their 30s; some people it’s not until their 50s. On average most of my patients are having enough trouble with their near focus that they are looking to address the issue around age 45.

Traditionally presbyopia is addressed through glasses: over the counter reading glasses, bifocals, or progressives. Multifocal contact lenses or even monovision (where you wear 1 contact lens for distance vision and 1 contact lens for near vision) are also options to help reduce glasses dependency for those who wear contact lenses. In 2021 the FDA approved Vuity (1.25% pilocarpine) as the first ever eye drop to temporarily improve near vision, but this first generation drop had difficulty meeting patient expectations for level of clarity achieved. In 2022 190,000 prescriptions for Vuity were filled in the USA, and in 2023 that declined to 120,000 prescriptions. With 128 million presbyopes in the USA, these numbers don't speak highly for successful market penetration.

Like Vuity, Qlosi (0.4% pilocarpine) is a miotic; it works by constricting the pupil to create a pinhole effect - improving near vision temporarily without reducing distance vision. And while both drops are pilocarpine formulations, there are several differences that indicate Qlosi may have more success in meeting patient needs. Researchers have found that they could improve effectiveness with 1/3 the concentration of pilocarpine (which would minimize drop side effects), and improved comfort and penetration with a near neutral pH and a preservative free formulation.

Qlosi was FDA approved based on the placebo controlled, double blind Phase 3 NEAR study which included over 600 participants age 45-64 year olds with a prescription between -4.50 to +2.00. Patient withs prior LASIK or cataract surgery were excluded, as were patient with high IOP (>22). Across the study, 40% of participants reached the primary study endpoint ≥3 line gain in near vision without loss of ≥ 1 line of distance vision just 1 hour after drop insertion, and 50% reached the primary study goal with a second drop dosed 2-3 hours later.

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Interestingly, neuroadaptation plays a role in the drop's success. On day one only 23.3% of patient reached the goal near vision 1 hour after drop insertion, while on day fifteen 47.9% of patients reached the near vision goal within 1 hour. It is recommended to use the drops daily for 2 weeks to get the best visual performance. A second drop instilled 2-3 hours after the first drop can help extend the length of near vision improvement up to 8 hours.

While you may read these numbers and say, well only half of patients achieved the goal of 3 or more lines of near vision improvement, is this really that amazing? Counter this with the GEMINI clinical study data from Vuity in which only 26-31% of patients achieved this same visual goal. All signs point to Qlosi being a significant improvement over the existing option on the market.

The most common treatment-related adverse events were headache (6.8%) and instillation site pain (5.8%). Of all Qlosi users, only 1.3% reported moderate treatment-related adverse events. All other adverse events were mild.

While no cases of adverse retinal events occurred during the clinical study, rare cases of retinal detachment have been reported with miotics. Examination of the peripheral retina is advised in all patients prior to initiation of therapy. Patients are advised to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss.

Want to learn more about Qlosi? Check out the Defocus Media interview with Dr. Jade Coats.

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