Have you heard about eye drops that slow down prescription worsening in children with myopia (or nearsightedness)? That's low dose atropine, and doctors have increasingly been offering this option to patients since the publication of the landmark LAMP and LAMP 2 Trials showed positive effects for dosages between 0.01% and 0.05% atropine used nightly. The reason that atropine drop use for slowing childhood prescription changes hasn't fully entered the main stream? Only 1% atropine is available at traditional pharmacies - a concentration so high that it would dilate the pupil for a week or more and cause considerable blurry vision, making it impractical for routine use for myopia management. Parents and doctors are left with having to use compounding pharmacies to create the lower doses of atropine needed for myopia management, and a designation of "off label" treatment which also gives many parents concerns. The idea of an FDA approved low dose atropine formulation for myopia management has thus been a big excitement for doctors in the myopia management community - making it easier for parents to access the drop, and allaying any fears about treatments that are off label. Sydnexis currently has approved low dose atropine available in Japan under the brand name Ryjusea and Europe under the brand name Ryjunea, and was slated for an FDA decision date on approval on October 23, 2025. The decision took many in the community by surprise: no FDA approval, and instead a request for more data. 

What did the FDA see (or not see) that caused them to pause low dose atropine approval? Let's dive into the details behind the Phase 3 STAR Study that was used for FDA submission:

STAR Study Set Up:

This STAR study is the largest low dose atropine study published to date, with 847 children between the ages if 3 to 14 enrolled. Study participants had between -0.50D to -6.00D of myopia at the time of enrollment, and countries of enrollment included the USA, Austria, and Slovakia. Participants were split 282 with vehicle (placebo), 282 with 0.01% atropine, and 283 with 0.03% atropine used nightly and followed every 6 months for 36 months. At that time all drops were stopped and a 12 month follow-up was performed to assess any rebound effect. Cycloplegic refraction was used to determine prescription at each follow-up visit. Primary study endpoint was defined as -0.75D  or less of myopia progression by 36 months of treatment.  

STAR Study Results

Patient receiving placebo drops by 36 months had myopic spherical progression rage of -0.38D/year on average. Treatment groups with 0.01% and 0.03% had no statistically significant difference in their effect: 0.01% atropine group had a -0.30D/year progression and 0.03% atropine group had a -0.32/D year progression. If you broke out "fast progressing" myopic patients (those changing at a rate of greater than -0.50D/year prior to enrolling in the study), the effect was slightly bigger, with a -0.41/D year average progression with vehicle, and -0.30D/year progression with 0.01% atropine and -0.32/D year progression with 0.03% atropine. 

Looking at this data alone, there was a 21% spherical equivalent myopia management effect with 0.01% atropine, and for fast progressors a 27% myopia management effect with 0.01% atropine for spherical equivalent. 

Link to Full Study PDF

The most effective myopia management effect was seen in a subgroup of fast progressors with prescriptions between -0.50 and -3.00D at enrollment: there was a 56.8% myopia management effect with 0.01% atropine with this one specific subgroup at 36 months. Interestingly, those taking 0.03% atropine in this subgroup only had a 22.1% myopia management effect.  Fast progressors with higher baseline prescriptions >-3.00 to -6.00D at enrollment only had a 19.5% myopia management effect with 0.01% atropine and a 25.3% effect with 0.03% atropine. 

Link to Full Study PDF

There was no reporting on axial length elongation with the published study data. 

No adverse events were reported with atropine use during the clinical trials.

Conclusion: The study authors concluded that for children aged 3-14 there was statistically significant benefit to slow myopia progression with 0.01% atropine, with the greatest benefit observed when treatment was initiated early in their myopic progression. See the subgroup of paitents between -0.50 and -3.00 with significantly stronger effect than those with prescriptions >-3.00 to -6.00D of myopia. 

The FDA's Conclusion: In their Complete Response Letter to Sydnexis' application for approval of SYD-101 (0.01% atropine) based on the STAR Study, the FDA acknowledged the primary endopoint goal was met of statistically significant reduction in myopic progression of -0.75D or better over 3 years. But the letter requested more data was needed to support the effectiveness of low dose atropine. 

The Reaction

Industry articles have characterized the FDA's decision as "baffling," and "puzzling", and personally I'll be the first to admit that I was surprised by this outcome after spending years practicing with the knowledge of the LAMP 2 study data. But when I saw the actual published study (released after the FDA's decision), the data is definitely not as strong as anything seen in previous atropine studies and warrants some questions on why this study failed to show a more robust myopia management effect. Let's compare the LAMP 2 study and the STAR study to illustrate this point:

Study Participants:  LAMP 2: 474 children, STAR: 874 children (the largest atropine study to date!)

Location of Study: LAMP 2: China, STAR: USA, Austria, Slovakia (the most ethnically diverse atropine study to date!)

*Is there a difference in the response to low dose atropine among patients of different ethnicities? Even in the STAR study, if participants of Asian ethnicity were sub-grouped, 0.03% atropine had a more effective myopia management effect, compared to White/Hispanic/African American ethnicities which showed no statistically significant benefit with the higher atropine concentration.

Myopia Management Effect:

LAMP 2: 22% spherical equivalent myopia management effect with 0.01% atropine compared to placebo at the end of 1 year, 44% effect with 0.025% atropine, and 70% effect with 0.05% atropine. In the LAMP 2 study placebo users were switched to treatment groups after that 1 year time frame so there is not longer data for comparison.  

STAR: 21% spherical equivalent myopia management effect with 0.01% atropine over 3 years, 16% effect with 0.03% atropine over 3 years.

*Why didn't the STAR study similarly find that a higher concentration of atropine provided a more robust effect? Does it hark back to ethnicity impacting the benefit of low dose atropine? Or is this the result of a larger and longer study just showing less impressive results?

In the LAMP 2 study, axial length progression was also measured, showing a 18.7% myopia management effect in reduction in axial length elongation with 0.01% atropine after 1 year, 32.6% effect with 0.025% atropine, and 54% effect with 0.05% atropine.  In the STAR study no axial length progression data was provided. Did the FDA take issue with the lack of inclusion of axial length study data being presented?

My Opinion:

While I agree that the STAR study showed statistically significant myopia management effect, the results of this study felt surprisingly underwhelming. I was expecting a much more robust myopia management response based on the LAMP 2 study data, and was very surprised by the lack of improvement seen with the higher 0.03% atropine data compared to 0.01% atropine data in myopia management. We do expect a dose depenedent response to atropine based on previous studies like LAMP 2, and the fact that this was not seen in the STAR study causes some pause. Is the difference in data purely based on a difference in ethnic makeup of the study? And if so, does this similarly mean that United States doctors should expect less effective myopia management results when prescribing low dose atropine to their patients of a more diverse ethnic makeup?

One of the big things that held SYD101 approval back in my opinion was timing. If there was no other myopia management option available, then even a modest 21% myopia management effect would be better than nothing. But the FDA had just one month prior to this decision authorized Essilor Stellest lenses for myopia management with a reported 71% reduction in myopia progression and 53% reduction in axial elongation at 2 years, and MiSight contact lenses are already FDA approved since 2019 with a 59% myopia progression effect and 52% axial elongation reduction effect at 3 years. Both of these treatments show significantly more effective study data. I can picture someone at the FDA asking "why would a doctor prescribe low dose atropine when they have glasses and contact lens options available already, on-label, with significantly more robust data to support their effectiveness?"

Is there a place for FDA approval of atropine - yes, absolutely in my opinion. Studies have shown that using low dose atropine with myopia management glasses can be an effective combination treatment, and also in combination with MiSight contact lenses in fast progressors. Having an FDA approved version of atropine would help minimize risks of inaccurate dosage concentrations that have been reported with doctors using compounding pharmacies. We need standardization of low dose atropine in myopia management. But the FDA request for more study data does seem warranted as we look at some discrepancies in findings between what is considered the landmark atropine study (LAMP 2) used by doctors and what was reported in the STAR study. And I imagine some axial length elongation reporting was probably requested for the next submission as well.

 When your child gets the diagnosis of myopia (or near sightedness), there's a lot to take in. Suddenly you're talking about glasses and potentially contact lenses, and because there is no cure, a lifetime of needing those supports to be able to see. Refractive surgery to correct vision is not an option until at least age 18 and has it's own side effects to consider. And then on top of all of this information, your doctor explains that your child not only has myopia, but studies show that their vision will get WORSE every year by an average of 0.50-0.75 diopters until they stop growing, around age 18. 

"What if we don't do glasses then? Or what if we cut the prescription down in the glasses (undercorrect the myopia)?" you might be tempted to think. Studies show that will only make the eyes worsen faster.

For the past several decades as more and more research has been published, there has been no statistically significant, meaningful method of slowing down childhood prescription worsening with glasses, despite efforts with undercorrection, bifocals, prism, and progressives. If a parent wanted to slow down the rate of their child's worsening vision, their only options for myopia management were FDA approved multifocal contact lenses called MiSight, orthokeratology corneal molds for overnight wear, or off-label low dose atropine. All of these options have their own pros and cons, and many parents are hesitant to initiate nightly eye drops or contact lens wear into their young child's day to day routine. 

At least, this was true until September 25, 2025 when the FDA granted marketing approval for the first ever glasses to slow down the progression of myopia: Essilor Stellest. 

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How Does it Work?

Unlike traditional glasses, the Stellest lens has 1021 tiny highly aspheric lenslets arranged in 11 distinct rings 9 millimeters around the central visual axis. Called HALT technology (highly aspheric lenslet target), these lenslets create a phenomenon called peripheral myopic defocus for light falling into the retina. Want to nerd out about peripheral defocus? Read my summary here!

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How Well Does it Work?

Essilor Stellest lenses have a large amount of data to support their effective myopia management benefits. Back in 2021 they were designated as a breakthrough novel device by the FDA based on initial data, and over the ensuing years more and more clinical study data has been compiled both in clinical trials around the US and in other countries where doctors were already prescribing this lens for myopia management. Here's how the data breaks down:

Two Year Study Data: This study included 157 children ages 8-13 with prescriptions between -0.75D to -4.75D who were randomly assigned to single vision (normal) glasses correction or HALT lens correction (Stellest lenses) for full time wear (12 or more hours per day). For those wearing the HALT lens design, there was a 67% slowing of prescription progression (worsening prescription) and 60% reduction in axial length progression (elongation of the eye).

Six Year Study Data: After 6 years of HALT lens wear, a 57% slowing of prescription progression and 52% reduction in axial length progression was demonstrated compared to single vision lens wear. Additionally, the risk of progressing to high myopia (defined as -6.00D or worse) dropped from 38% in the single-vision lens control group to just 9% in the HALT lens group.

These results are comparable to study data for the existing myopia management strategies available, making HALT glasses an excellent option to consider for parents who want to reduce the chance that their children's vision will get worse as they grow. No longer do parents only have the option of starting their child on eye drops or contact lenses in order to keep their prescription as low as possible; with myopia management glasses now FDA approved, doctors can prescribe whatever option is best for the child and their family and keep the child's vision as clear as possible!

CooperVision recently announced the following contact lens product discontinuations:

• Biomedics 55 Premier: Trial lenses discontinued May 1, 2025. Boxes discontinued May 1, 2026
• Biomedics Toric: Trial lenses discontinued May 1, 2025. Boxes discontinued May 1, 2026
• Clariti 1 Day Multifocal: Trial lenses discontinued July 1, 2025. Boxes discontinued January 1, 2026

Clariti 1 Day Multifocal 3 Add via

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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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The study began in 2018 with children aged between 8 and 13 years old. After completing the initial five-year study phase, participants continued wearing Essilor Stellest lenses for an additional two years to assess the long-term impact on myopia progression.

• The six-year results showed that Essilor Stellest lenses slowed prescription progression by 1.95 D (57% prescription progression reduction) and slowed axial elongation by 0.81 mm (52% axial length progression reduction)
• Risk of progressing to high myopia (defined as -6.00D or worse) dropped from 38% in the single-vision lens control group to just 9% in the Essilor Stellest lenses group

An estimated 19.8 million Americans over the age of 40 have a diagnosis of macular degeneration (AMD), which can cause significant central vision loss as the disease progresses from year to year. Genetics, lifestyle, and diet are all major risk contributors, but the older we live, the aging process also plays a significant role in our increased risk of AMD. By age 80, 30% of Americans have macular degeneration. A number of treatments have changed the way we manage macular degeneration and preserve the vision of those affected. Anti-VEGF treatments for wet macular degeneration are the standard of care to preserve and in some cases even improve vision. Dry macular degeneration has been historically without treatment, but in 2023 the FDA approved two treatments for the most severe form of dry AMD, geographic atrophy. These injections can slow the worsening of this condition but did not show any vision improvement. So for the the majority of patients with AMD (90% of Americans with macular degeneration have the dry form of the disease), there has been no treatment that could improve or restore any vision that person had lost.

Until now.

On November 5, 2024, the FDA approved the Valeda Light Delivery System as the first ever treatment for vision improvement in patients with dry AMD. The treatment is for patients in the early stages of dry AMD that have not progressed to geographic atrophy. The device uses photobiomodulation, a treatment currently used in arthritis, wound repair, physiotherapy and sports medicine, which targets the mitochondria at the cellular level to stabilize metabolic cellular function. In AMD, the macular photoreceptor cells are struggling to metabolize light energy and free radical damage, resulting in the build up of waste and debris (drusen) at the macula, inflammation, and as the condition advances, scar tissue (geographic atrophy) and bleeding inside the eye (wet macular degeneration). By targeting the mitochondria of macular photoreceptor cells to increase metabolism, increase ATP (energy!) production, and boost cellular repair in response to light and free radical damage, tissue function is better preserved and protected. Using this photobiomodulation approach, the Phase III LIGHTSITE trial showed that patients gained an average of 5 letters of improvement in vision over a 2 year period using the device. Let's break down the data from this pivotal study:

The LIGHTSITE III trial was a double-masked, sham controlled, multi-center study that was run at 11 eyecare centers across the United States and included 100 patients (148 eyes) with early or intermediate stage dry AMD. Included study participants were age 50 or older (average age was 74.4), and had best corrected vision of 20/100 to 20/32 Snellen Acuity. Patients with geographic atrophy or wet AMD were not included in this study. If a patient had significant cataract that would affect vision or would require surgery in the next 2 years, or a history of other eye conditions or diseases that can affect vision including glaucoma, retinal vascular diseases, macular edema, amblyopia (lazy eye), or nystagmus, they were also excluded. Because the treatment is light-based, any patients that had light sensitivity disorders (including history of seizure, epilepsy, or migraine) or that were taking photosensitizing medications could not participate.

The Valeda device is an in office treatment that stimulates improvement in cellular metabolism. Currently available in Europe and South America, this device is now FDA approved and will be available in the USA at eye doctor in the near future. via

Treatment: Subjects were given in office treatments with the Valeda device using photobiomodulation at 3 wavelengths: 590 (yellow), 660 (red), and 850 nanometers (near infra-red), or a sham treatment that emitted much less light (the sham mode delivered 50x less 590 nm, 100x less 660 nm wavelengths and no 850 nm wavelengths).  Participants received these treatments over 9 sessions spaced over 3-5 weeks every 4 months for a period of 24 months. 

Results: At 13 months the Valeda-device treatment group had a statistically significant improvement in gained visual acuity over the sham treatment group. At month 13 patients had received 4 series of treatment, and the average change from baseline in best corrected vision was +5.4 letters in the treatment group, versus +3 letters in the sham group. Over half (55.5%) of patients in the treatment group increased vision by more than 5 letters: 26.4% of the treatment group had 10 or more letter gain, and 5.5% had a 15 or more letter gain in best corrected vision. At 24 months, these results were sustained, with an average improvement of 5.9 letters from baseline in the treatment group.

In addition to an improvement in best corrected vision, the treatment group also showed a reduced risk of vision loss over the study period. Only 7% of treated eyes lost more than 5 letters during the 24 months of the study, versus 18% of the sham treatment group who lost more than 5 letters of best corrected visual acuity. 

Also, significantly fewer of the Valeda device treatment group went on to develop geographic atrophy over the 24 month study. 6.8% of the treatment group developed geographic atrophy versus 24% of the sham group. 

The device was well tolerated with 3 participants having device-related adverse events- all of which were dry eye in nature. 5 of the study participants with treatment went on to develop wet AMD versus only 1 of the sham group, but these results were not deemed to be statistically significant on review (treatment versus sham group enrollment was 2:1). 

Stay Tuned: Now that this device is FDA approved, the developer LumiThera will need time to ramp up production and develop access channels. You can sign up on their website to get updates about device availability. They also have a Valeda locator on their website (but right now no offices in the United States are listed).