An in-depth look at the FDA approvals and clinical milestones that defined 2025 and how they are poised to influence practice patterns moving into 2026.
Editor's Note: This content was generated with the assistance of AI.
From first-in-class pharmacologic therapies to next-generation retinal durability strategies and less invasive surgical platforms, 2025 emerged as a pivotal year for the ophthalmic pipeline. Over the past 12 months, the US Food and Drug Administration (FDA) delivered a series of approvals that reshaped treatment paradigms across retina, cornea, cataract, refractive surgery, and ocular surface disease. More than incremental wins, these regulatory decisions signaled clear inflection points in how eye disease is treated—prioritizing sustained efficacy, novel mechanisms of action, and reduced treatment burden, while broadening clinician choice across subspecialties.
What follows is an in-depth look at the FDA approvals and clinical milestones that defined 2025 and how they are poised to influence practice patterns moving into 2026.
The MEL 90 approval signals continued consolidation toward fully integrated refractive platforms. Practices invested in SMILE and femtosecond technologies may benefit from streamlined workflows, faster treatments, and consistency across procedures—key factors for both outcomes and operational efficiency.
The FDA approval of the ZEISS MEL 90 excimer laser represented more than a single-device clearance—it marked the completion of ZEISS’ Corneal Refractive Workflow in the US. Approved for myopia, hyperopia, and mixed astigmatism, the MEL 90 integrates with the VISUMAX 800 femtosecond laser and SMILE pro software, enabling surgeons to deliver LASIK and lenticule-based procedures within a unified platform.
Clinically, the system’s Triple-A (advanced ablation algorithm) technology stood out for its tissue-sparing profile, high predictability, and rapid ablation speed. For refractive surgeons, this approval reinforced an ongoing shift toward platform-based ecosystems that emphasize efficiency, reproducibility, and scalability in high-volume practices.
Epithelium-on cross-linking may meaningfully change referral patterns and timing of care. Reduced procedural morbidity could support earlier treatment, improved patient acceptance, and broader screening initiatives for keratoconus.
Perhaps one of the most practice-altering approvals of the year came with Glaukos’ Epioxa, the first FDA-approved corneal cross-linking therapy that does not require epithelial removal. The incision-free, epithelium-on approach addresses long-standing barriers to cross-linking adoption, including postoperative pain, prolonged recovery, and patient reluctance.
Backed by phase 3 pivotal trial data, Epioxa’s approval has significant implications for earlier intervention in keratoconus—a disease that remains underdiagnosed despite its progressive and potentially sight-threatening nature. By lowering the procedural threshold, the therapy may expand access to treatment and shift the timing of intervention closer to diagnosis.
BVI’s FineVision HP trifocal intraocular lens received FDA approval in 2025, formally introducing a lens with more than 15 years of international clinical use to the US market. As premium cataract surgery continues to evolve, the availability of a well-established trifocal option offers surgeons additional flexibility when addressing patient expectations for spectacle independence.
With a diffractive optic designed to deliver balanced far, intermediate, and near vision, FineVision HP enters a competitive premium IOL landscape increasingly focused on customization and patient-reported outcomes. Its phased US rollout positions it as a notable addition for practices seeking to broaden premium offerings.
Pharmacologic presbyopia treatment introduces a non-surgical option that may complement premium IOLs and refractive procedures, altering how surgeons counsel early presbyopes and manage expectations across the aging spectrum. Unlike earlier pharmacologic approaches, VIZZ employs a pupil-selective miotic designed to minimize ciliary muscle stimulation while extending depth of focus.
Presbyopia management reached a turning point with FDA approval of LENZ Therapeutics’ VIZZ (aceclidine 1.44%), the first and only aceclidine-based eye drop approved for near vision correction. Unlike earlier pharmacologic approaches, VIZZ employs a pupil-selective miotic designed to minimize ciliary muscle stimulation while extending depth of focus.
Phase 3 CLARITY trial data demonstrated rapid onset—within 30 minutes—and durability lasting up to 10 hours, supporting once-daily dosing. For ophthalmologists, the approval represents a meaningful expansion of presbyopia treatment beyond lenses and surgery and may reshape patient conversations around early intervention and lifestyle-driven vision correction.
Phase 3 CLARITY trial data demonstrated rapid onset—within 30 minutes—and durability lasting up to 10 hours, supporting once-daily dosing. For ophthalmologists, the approval represents a meaningful expansion of presbyopia treatment beyond lenses and surgery and may reshape patient conversations around early intervention and lifestyle-driven vision correction.
Alcon’s Tryptyr (acoltremon ophthalmic solution 0.003%) became the first TRPM8 receptor agonist approved for the treatment of dry eye disease. By stimulating corneal sensory nerves to enhance natural tear production, Tryptyr introduced a distinct neurosensory mechanism of action in a crowded and heterogeneous treatment landscape.
Supported by the COMET-2 and COMET-3 phase 3 trials, the therapy demonstrated statistically significant increases in tear production as early as day one. The approval reflects growing recognition of dry eye disease as a multifactorial condition requiring mechanism-driven treatment stratification.
Complementing innovation at the branded-drug level, FDA approvals of generic cyclosporine ophthalmic emulsion 0.05% and loteprednol etabonate ophthalmic gel 0.38% helped expand access to foundational therapies for chronic dry eye and postoperative inflammation. These approvals underscore the FDA’s dual role in fostering innovation while supporting affordability across ophthalmic care.
Longer refill intervals may improve adherence and reduce clinic congestion, particularly for patients with chronic bilateral disease. Sustained delivery platforms also open new discussions around earlier intervention and durability-driven treatment strategies.
Genentech’s Susvimo platform continued to gain momentum in 2025 with FDA approvals for diabetic macular edema and diabetic retinopathy, adding to its original indication for wet age-related macular degeneration. The refillable ocular implant, which delivers ranibizumab continuously with refills every six to nine months, directly addresses treatment burden—one of the most persistent challenges in retinal care.
Phase 3 data supporting these approvals demonstrated noninferior visual outcomes compared with monthly injections, reinforcing the role of sustained delivery platforms in long-term disease management.
Neurotech Pharmaceuticals’ approval of ENCELTO (revakinagene taroretcel-lwey) marked the first FDA-approved treatment for macular telangiectasia type 2. Utilizing encapsulated cell therapy to deliver ciliary neurotrophic factor (CNTF) directly to the retina, ENCELTO represents a significant advance for a previously untreatable neurodegenerative retinal disease.
The approval validates encapsulated cell therapy as a viable long-term delivery strategy and may have broader implications for future gene- and cell-based approaches in ophthalmology.
Regeneron’s EYLEA HD (aflibercept 8 mg) received FDA approval for macular edema following retinal vein occlusion, offering extended dosing intervals that can reduce injection frequency while maintaining efficacy. At the same time, Celltrion’s EYDENZELT—an aflibercept biosimilar referencing EYLEA—entered the US market, intensifying competition and potentially improving access to anti-VEGF therapy.
Together, these approvals highlight parallel trends in retina care: the pursuit of longer durability and the growing influence of biosimilars on treatment economics.
Across subspecialties, the FDA approvals of 2025 shared common themes: longer-lasting therapies, less invasive procedures, and an expanding emphasis on mechanism-based treatment selection. For ophthalmologists, the year delivered not only new products but also new strategic considerations around workflow, patient counseling, and long-term disease management.
As these therapies transition from approval to widespread clinical adoption, their real-world impact will continue to shape practice patterns. What is already evident, however, is that 2025 will be remembered as a year when the ophthalmic pipeline translated decisively into meaningful clinical progress.
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