In the News
Alcon and Staar Surgical announced the companies have entered into a definitive merger agreement through which Alcon intends to acquire Staar. The acquisition includes the EVO family of lenses (EVO ICL) for vision correction for patients with moderate to high myopia, with or without astigmatism. The transaction represents a total equity value of approximately $1.5 billion. Alcon also announced the US commercial availability of Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease (DED). Approved by the US Food and Drug Administration (FDA)in May, Alcon said eyecare professionals across the United States can officially begin prescribing Tryptyr to their patients. In addition, Alcon announced its intention to acquire LumiThera, Inc. and its Valeda Light Delivery System photobiomodulation (PBM) device for the treatment of early and intermediate dry AMD.
Lenz Therapeutics announced the FDA approval of Vizz (aceclidine ophthalmic solution) 1.44 %, an eye drop for the treatment of presbyopia in adults. Vizz contracts the iris sphincter muscle resulting in a pinhole effect and achieves a pupil diameter less than 2 mm, which extends depth of focus to significantly improve near vision without causing a myopic shift. According to the company, samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by the end of 2025.
Regener-Eyes announced the FDA has officially closed the voluntary product recall of Regener-eyes PRO and LITE, marking full recall regulatory resolution and a return to normal operations. After a comprehensive review, the company identified a potential concern and introduced an enhanced bottle design featuring advanced backflow prevention technology to help protect against microbial contamination. The company said this improvement further safeguards product integrity and demonstrates its commitment to continuous improvement.
Lupin Limited received approval from the FDA for its abbreviated new drug application (NDA) for loteprednol etabonate ophthalmic gel, 0.38%, a bioequivalent to Bausch + Lomb’s Lotemax SM ophthalmic gel, the company said in a press release. Loteprednol etabonate ophthalmic gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
Aldeyra Therapeutics announced that the FDA has accepted for review the resubmitted NDA for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of DED. The FDA assigned a Prescription Drug User Fee Act target action date of December 16, 2025.
Optomed launched Optomed Lumo, its next-generation handheld fundus camera. According to the company, Lumo was designed with input from physicians and offers intuitive operation with high-quality imaging and AI-enhanced diagnostic platforms, enabling faster decision-making. Initial deliveries are expected to begin in Q3 2025 in selected markets, with a broader rollout planned in subsequent quarters.
Altris AI released Altris Sync, a secure application that syncs AI directly to optical coherence tomography (OCT) devices from 8 OCT manufacturers. The introduction of Altris Sync for automated upload of OCT files is designed to remove the need for manual operations and bring AI decision support for OCT analysis to every clinic. Altris Sync now connects OCT devices from Carl Zeiss MediTech, Canon, Topcon, Heidelberg Engineering, Visionix, Nikon (Optos), Optopol, and Nidek.
Ziemer USA, in partnership with CorneaGen, launched the Galilei CTAK module, which is now available for use with the Galilei diagnostic platform. The module is now available in the US market and requires a software update to existing Galilei systems. Ziemer USA said these advancements underscore its ongoing commitment to the US refractive market, with a strong focus on corneal therapeutics and enhancing outcomes for patients with keratoconus.
Viatris Inc’s phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after 6 weeks of twice-daily dosing. The company said it is focused on delivering novel therapies such as Tyrvaya and Ryzumvi, while progressing a differentiated pipeline that addresses unmet needs in anterior segment conditions.
Bausch + Lomb reported results from a phase 3 study that assessed the efficacy and safety of Lumify Preservative Free redness reliever eye drops compared to Lumify redness reliever eye drops for reducing ocular redness. The study met its primary objective, confirming that Lumify Preservative Free is statistically non-inferior to Lumify in reducing ocular redness in adults.
Opus Genetics reported positive results from VEGA-3, its second pivotal phase 3 trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia. The trial met its primary endpoint, with a statistically significant 27.2% of participants treated with the drug achieving a ≥15-letter improvement in binocular DCNVA and less than a 5-letter loss in binocular BCDVA at 12 hours post-dose on day 8, compared to 11.5% of patients on placebo.
EyePoint Pharmaceuticals completed enrollment for its phase 3 LUCIA trial evaluating the vorolanib intravitreal insert (Duravyu, formerly EYP-1901), a potential treatment for neovascular age-related macular degeneration. More than 400 patients have been randomized into the study within 7 months. LUCIA is the second of 2 pivotal noninferiority trials in the Duravyu phase 3 program. The company expects top-line data in the third quarter of 2026.
Cloudbreak Pharma reported positive results from its phase 2 trial evaluating CBT-004 ophthalmic solution in patients with vascularized pinguecula and associated conjunctival hyperemia. Significant improvements were observed as early as day 7 in patients dosed with the highest investigated concentration of CBT-004, with benefits persisting through the 28-day treatment period.
Okyo Pharma LTD reported positive data from the phase 2 trial of urcosimod to treat neuropathic corneal pain. For the per-protocol population, change in mean pain score was 5.5 in the 0.05% urcosimod group and 2.75 in the placebo group, reflecting a 2.75 delta difference between drug and placebo following the 12-week treatment period. Notably, 75% of patients treated with 0.05% urcosimod achieved greater than 80% improvement in pain severity.
Ashvattha Therapeutics released interim results from its ongoing phase 2 study of subcutaneous migaldendranib for the treatment of diabetic macular edema (DME) and wet AMD. DME patients exhibited an increased BCVA of +4.5 letters and a decreased central subfield thickness (CST) of -69.1 µm, with an observed reduction in treatment burden by 80%. Wet AMD patients maintained stable mean BCVA and CST for 24 weeks with +3 letters, -45.5µm CST, and a 79.9% reduction in treatment burden.
Harrow entered into a definitive agreement with Samsung Bioepis to secure the exclusive US commercial rights to its ophthalmology biosimilar portfolio—Byooviz (ranibizumab-nuna), an FDA-approved biosimilar referencing ranibizumab (Lucentis; Genentech), and Opuviz (aflibercept-yszy), an FDA-approved biosimilar referencing aflibercept (Eylea; Regeneron).
Topcon Healthcare announced the acquisition of Intelligent Retinal Imaging Systems (IRIS), a US-based company that is known for its cloud-based retinal screening technology. This acquisition strengthens Topcon Healthcare’s from the Eye initiative by expanding the use of ocular data and AI-assisted screening across both primary care and eyecare settings.
Aeye Health formed a strategic partnership with Ford Medical that will bring Aeye’s fully autonomous diabetic eye exam screening solutions to pharmacies and non-acute centers nationwide. AEYE-DS, Aeye Health’s AI-driven technology, enables point-of-care screening for patients who may not regularly see an eye
specialist, the company said.
Boehringer Ingelheim and Re-Vana Therapeutics announced a strategic collaboration and license agreement to develop first-in-class extended-release therapies for ocular diseases. Re-Vana’s drug delivery technology is designed to release medications over a 6-month to 12-month period, significantly reducing the number of injections some ocular therapies require. Boehringer Ingelheim said it will investigate combining this extended-release technology with its own pipeline of treatments aimed at preserving the retina.
A coalition of leading eyecare and research organizations has launched a nationwide campaign to protect the National Eye Institute (NEI) from proposed federal restructuring and funding cuts. The initiative comes in response to mounting concerns over potential efforts to consolidate the NEI into a broader agency focused on brain and dental research. Such a move, advocates say, could significantly undermine progress in eye health and vision-related discoveries.
The Centers for Medicare and Medicaid Services (CMS) proposed CY 2026 payment rate regulation for hospital outpatient departments and ambulatory surgery centers contains good news, including a 2.4% average increase in payment rates. According to the Outpatient Ophthalmic Surgery Society, the proposed rule incorporates multiple policies for which the society has long advocated. Changes include CMS extending its policy of the 2019-2025 period, in which CMS updated ASC payment rates by the Hospital Market Basket rather than the lower Consumer Price Index-Urban, to 2026 while it further studies the issue. The resulting 2.4% payment increase represents an average across all ASC procedures.
Sight Sciences announced that the manuscript detailing 24-month results from stage 3 of the SAHARA randomized controlled trial has been published by Optometry and Vision Science. The study showed that all mean signs and symptoms remained statistically significantly better than the study baseline at all timepoints measured through the end of the study at 24 months. The majority (66%) of participants who received treatment for DED with the TearCare System (TearCare) at baseline and again at Month 5 required no additional treatment based on pre-defined retreatment criteria.
Eyesafe published a report that finds that people born in 2025 will likely spend 21 years of their lives looking at a screen. The report synthesizes data from the US Bureau of Labor Statistics, Nielsen, and other sources to reveal that its finding of 181,000+ hours staring at a screen amounts to over a quarter of a person’s life and more than 40% of their waking hours. The report also highlights a massive generational shift, Eyesafe notes.
A large observational study using US Medicare data expands on prior evidence regarding the association between the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and an increased risk of developing nonarteritic anterior ischemic optic neuropathy (NAION) in older patients with type 2 diabetes. The retrospective cohort study, published as a research letter in JAMA Ophthalmology, revealed that semaglutide and liraglutide showed the highest risk, while dulaglutide and exenatide were not significantly associated with NAION.
Heidelberg Engineering announced an advancement in the use of artificial intelligence (AI) for ophthalmic diagnostics, with the publication of the Eye2Gene study titled “Next-generation phenotyping of inherited retinal diseases from multimodal imaging with Eye2Gene” in Nature Machine Intelligence. The study highlights the potential of AI-powered analysis of multimodal Spectralis imaging to accelerate genetic diagnosis in patients with inherited retinal diseases.
Rain Eye Drops LLC launched the RainDrop Dispenser Aid, a newly refined device exclusively licensed from the US Department of Veterans Affairs (VA). According to the company, this patented tool is designed to help Americans who have dry eye apply mono-dose eyedrop vials more easily and accurately.
Corza Medical announced the company has expanded its Onatec Ophthalmic Suture Portfolio, adding nearly 130 products tailored for ophthalmic and oculoplastic surgery. The updated portfolio includes a range of absorbable and non-absorbable sutures paired with precision-engineered Onatec Needles. The launch is aimed at improving surgical performance in delicate eye procedures, the company said. OM