2025 takes dry eye, presbyopia by storm

The past year marked a pivotal period for optometry, with 2025 delivering meaningful clinical, regulatory, and legislative developments that reshaped eyecare practice. Innovation remained front and center as the US FDA authorized Essilor’s Stellest lenses for myopia correction and advanced multiple pharmaceutical options addressing presbyopia, dry eye disease, amblyopia, and retinal conditions. New approvals—including LENZ Therapeutics’ Vizz (aceclidine 1.44%), Alcon’s Tryptyr (acoltremon ophthalmic solution 0.003%), Orasis’ Qlosi (pilocarpine hydrochloride ophthalmic solution 0.4%), and Regeneron’s Eylea HD (aflibercept injection 8 mg)—expanded the therapeutic toolbox available to eyecare providers, reinforcing optometry’s growing role in eye care.

At the same time, regulatory decisions highlighted both progress and ongoing challenges. The FDA’s clearance to expand Luminopia’s amblyopia treatment to older pediatric patients represented a notable win for pediatric eyecare, while a complete response letter to Sydnexis for SYD-101 underscored the rigor of the approval pathway for myopia control therapies. On the policy front, scope of practice and reimbursement dominated the conversation. Minnesota’s first scope expansion bill in more than 2 decades and Arkansas’ proposed vision benefit manager regulations signaled renewed momentum for optometric advocacy nationwide.

The top 10 stories in eye care reflect a year defined by therapeutic advancement, regulatory scrutiny, and legislative action—setting the stage for continued evolution in optometric care heading into 2026.

US FDA authorizes marketing of Essilor Stellest eyeglass lenses for the correction of myopia

The US Food and Drug Administration (FDA) has now authorized marketing of the Essilor Stellest eyeglass lenses for the correction of myopia with or without astigmatism.^1,2 The lens works to slow the progression of myopia in children aged 6 to 12 years at the initiation of treatment, according to an FDA news release.

The FDA had previously granted breakthrough device designation for the lenses on April 30, 2021, which allowed for the expedition of the development and review of the lens. Now, the lens was granted marketing authorization through the de novo premarket review pathway to Essilor of America Inc.¹

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FDA approved LENZ Therapeutics’ VIZZ for the treatment of presbyopia

LENZ Therapeutics has announced that the FDA has approved its formulation of aceclidine 1.44% for the correction of near vision in adults with presbyopia. This formulation is the first and only FDA-approved aceclidine eye drop indicated for presbyopia, and its unique mechanism of action relies on a pupil-selective miotic that interacts with the iris and recruits ciliary muscle minimally. In clinical trials, the formulation showed efficacy for up to 10 hours following instillation.¹

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FDA approves Alcon’s Tryptyr (AR-15512) for signs and symptoms of dry eye disease

Alcon announced that the FDA has approved acoltremon ophthalmic solution 0.003%, a first-in-class transient receptor potential melastatin 8 (TRPM8) receptor agonist, for the treatment of the signs and symptoms of dry eye disease (DED). The drop, previously known as AR-15512, will be sold under the name Tryptyr. The neuromodulator stimulates corneal sensory nerves to increase natural tear production rapidly following instillation.¹

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FDA clears expansion of Luminopia amblyopia treatment to include 8 to 12 year old patients

Digital health company Luminopia has announced that the US Food and Drug Administration (FDA) has cleared its amblyopia treatment for patients 8 to 12 years old, which expands its existing label from patients 4 to 7 years old to patients 4 to <13 years old with amblyopia associated with anisometropia and/or mild strabismus.1 This allows for 400,000 8- to 12-year-olds in the US the access a new treatment options for their strabismus diagnosis, according to a news release.

This expansion marks the first FDA clearance for an amblyopia treatment for this age range in more than 2 decades. This decision was based on Luminopia’s robust database of real-world evidence as generated through its Patient Using Prescription Luminopia (PUPiL) registry (NCT06429280).¹

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FDA sends CRL to Sydnexis for SYD-101 to slow myopia in children

Sydnexis Inc has received a complete response letter (CRL) from the FDA regarding its new drug application (NDA) for 0.01% atropine formulation (SYD-101), intended to slow the progression of pediatric myopia.¹

The company’s NDA for the low-dose atropine formulation, developed to enhance ocular delivery and remain stable at room temperature, was backed by data from the phase 3 Study of Atropine for the Reduction of Myopia Progression (STAR) trial (NCT03918915)—believed to be the largest completed clinical investigation of myopia in children on a global scale.^1,2 The trial involved over 800 children aged 3 to 14 years at the start of treatment.^1,2 It achieved its primary efficacy goal, which measured the proportion of participants showing confirmed myopia progression of –0.75 diopters (D), a benchmark recommended by the FDA, according to the company.¹

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Orasis Pharmaceuticals’ prescription pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi) for presbyopia available in the US

Orasis Pharmaceuticals announced that its novel corrective eye drop for the treatment of presbyopia in adults (Qlosi; pilocarpine hydrochloride ophthalmic solution 0.4%) is available to prescribe in the US.¹

The topical ophthalmic solution is preservative-free, packaged in single-use vials, and includes dual lubricants—hyaluronic acid and hydroxypropyl methylcellulose—for patient comfort.¹ Patients can enjoy the flexibility of using a single drop per eye for improved near vision for a specific occasion or activity, or up to 2 drops daily for an extended effect lasting up to 8 hours. Prescriptions can be filled through BlinkRx or Medvantx, with free home delivery.

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Minnesota passes first scope expansion bill in over 2 decades

The Minnesota Optometric Association is celebrating recent legislation that was passed in the form of the state’s first optometric scope expansion bill in more than 20 years. The law will work to remove outdated restrictions on medications and allow some in-office procedures, and will take effect in August, according to an American Optometric Association news release.

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FDA expands Susvimo’s indications to include diabetic retinopathy

The US Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR). Susvimo is the first and only FDA-approved, continuous delivery treatment shown to maintain vision in people with DR with just one refill every 9 months, according to the company.

Susvimo 100 mg/mL is indicated for the treatment of patients with neovascular age-related macular degeneration (wet AMD), diabetic macular edema (DME), with the new addition of DR, to patients who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication.

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New Arkansas bill to instate VBM regulations, prioritize fair reimbursement and patient choice

Arkansas Governor Sarah Huckabee Sanders signed HB 1353 (Act 142 of 2025) into law, which will work to rebalance providers’ interactions with vision benefit managers (VBMs). The act will allow ODs in the state of Arkansas to receive fair reimbursements, increase reimbursement certainty, and establish payment protection, among other regulations.1 Act 142 will take effect in August 2025 with additional provisions to roll out based on plan renewals, contract changes, or by January 1, 2026, according to an American Optometric Association (AOA) news release.

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FDA approves Regeneron's Eylea HD injection for macular edema following RVO

The FDA has approved aflibercept injection 8 mg (Eylea HD) from Regeneron Pharmaceuticals for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every-8-week dosing after an initial monthly dosing period.

Additionally, the agency approved a monthly dosing option for some patients who may benefit from resuming this schedule across approved indications. These include wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and RVO.¹

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