What’s new in 2025-2026: Ophthalmic drugs and drug delivery systems

Continuous innovation is needed in ophthalmic drugs and delivery systems. The World Health Organization estimates that globally, at least 2.2 billion people have some form of vision impairment. In at least 1 billion of these cases, vision impairment could have been prevented or is yet to be addressed, posing a tremendous financial burden.¹

Chronic ocular diseases such as glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy can cause severe visual impairment. Other eye conditions, such as ocular surface disease (including dry eye disease [DED], blepharitis, meibomian gland dysfunction, and neurotrophic keratitis, etc), adversely affect vision and quality of life for our patients.

The eye’s very complex anatomy presents multiple physiological barriers (ie, the blood-retina barrier and the tear drainage system) to drug absorption and limits drug bioavailability to the target tissues. Therefore, the objectives of new ophthalmic drug delivery systems include optimal sustained drug concentrations at target sites. Anterior and posterior segment sites present different challenges. Reducing the frequency of administration with sustained-release modalities has the potential to improve patient adherence and ultimately improve medical outcomes. Traditional eye drops often lead to variable concentration profiles that are not ideal. Anterior segment ophthalmic challenges include inadequate corneal permeability, nasolacrimal drainage, and tear washout. Posterior segment challenges include the large volume of the vitreous humor and the blood-retina barrier. The unique and complex anatomy of the eye creates significant physiological barriers that limit drug bioavailability (ie, tear turnover, the blood-retina barrier).

Let’s first discuss the new ophthalmic drugs approved in 2025 and highlight their potential benefits for patients. In the last year, the FDA approved these ophthalmic medications:

Anti-inflammatories and dry eye medications

• Lupin’s loteprednol etabonate ophthalmic gel, 0.38% is a corticosteroid for the treatment of postoperative inflammation and pain following ocular surgery.² It is reported to be the bioequivalent of Bausch & Lomb’s Lotemax SM ophthalmic gel.³
• Acoltremon ophthalmic solution 0.003% (Tryptyr) is a TRPM8 receptor agonist that significantly increases early natural tear production and is approved for the treatment of DED. The drug has a novel mechanism that triggers TRPM8 cold receptors on the ocular surface. It is similar to varenicline solution (Tyrvaya) nasal spray, which triggers the lacrimal functional unit, stimulating the production of tears in the patient for hours. Acoltremon ophthalmic solution 0.003% has the potential to be used for presurgical patients where a faster response than other typical anti-inflammatory medications is desirable.⁴

Presbyopia medications

• Aceclidine ophthalmic solution (Vizz 1.44%; LENZ Therapeutics) was FDA approved on July 31, 2025, as an aceclidine-based eye drop for the treatment of presbyopia in adults. It utilizes a novel pupil-selective miotic to improve near vision. Aceclidine ophthalmic solution 1.44% has not previously been approved in the United States, although it is used to treat glaucoma in Europe. The agent is intended for use once daily and is preservative free. It contains aceclidine, which interacts with the iris via minimal ciliary muscle stimulation. The drug can improve near vision without causing a myopic shift. Data from the CLARITY phase 3 clinical trials reported that 93% of participants achieved a near visual acuity of 20/40 or better within 30 minutes, with this improvement lasting up to 10 hours.^4-8

Anti-VEGF medications

• Ranibizumab injection 100 mg/mL (Susvimo) has received approval for its continuous delivery system to treat diabetic retinopathy (DR). It is the only FDA-approved continuous delivery treatment offering VEGF suppression and has been shown to maintain vision in patients with DR with just 1 refill every 9 months. Ranibizumab injection was first approved in 2021 for the treatment of wet AMD and in early 2025 for diabetic macular edema. The intravitreal use of the drug via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure, continuously delivering a customized formulation of ranibizumab over time. Ranibizumab is a VEGF inhibitor that binds to and inhibits VEGF-A, a protein that plays a crucial role in the formation of new blood vessels and the leakiness of blood vessels.⁹

Innovations in ophthalmic drugs, delivery systems, and development programs are complex, decades long, and very expensive. Nanotechnology-based platforms are evolving and being studied. They have advantages, limitations, and challenges in addressing ocular drug delivery. These nanobased drug delivery systems are drawing increased attention due to their potential to increase bioavailability and therapeutic efficacy. Further research in this area is necessary to foster innovation.^10,11

Lastly, artificial intelligence (AI) and other digital technologies have the potential to accelerate ophthalmic drug innovation and development. Utilizing machine learning algorithms and clinical and multiomic data sets, AI can begin to predict pharmacokinetics and pharmacodynamics and identify new drug targets. It can identify potential problems related to drug toxicity. AI-assisted multimodal ocular biomarkers and their monitoring support future personalized medicine initiatives.¹² Integrating AI into ophthalmic drug innovation can shorten long development timelines by enhancing efficiency and reducing costs.

We are just in the beginning stages of understanding the potential of AI in ophthalmic drug development. In ophthalmic care, we need better and more standardized regulations for AI to ensure both safe and equitable implementation for our patients and communities.

References

1. Blindness and vision impairment. World Health Organization. August 10, 2023. Accessed December 9, 2025. https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment

2. Harp MD. Lupin launches loteprednol etabonate ophthalmic suspension, 0.5, in the United States. Ophthalmology Times. July 19, 2025. Accessed December 9, 2025. https://www.ophthalmologytimes.com/view/lupin-launches-loteprednol-etabonate-ophthalmic-suspension-0-5-in-the-united-states

3. Lee A. Acoltremon: first approval. Drugs. 2025;85(10):1307-1310. doi:10.1007/s40265-025-02218-5

4. DeFino A. Alcon launches Tryptyr for dry eye in US. Healio. July 31, 2025. Accessed December 9, 2025. https://www.healio.com/news/optometry/20250731/alcon-launches-tryptyr-for-dry-eye-in-us

5. Aslam HG, Fatima M, Sajid H, Irshad NUN, Imran SB. FDA approval of aceclidine (Vizz): a new chapter in nonsurgical presbyopia management. Ann Med Surg (Lond). 2025;87(11):6923-6925. doi:10.1097/MS9.0000000000004008

6. McCabe CM, Schmidt EE. The emerging era of presbyopia-correcting eye drops: what’s next? Ophthalmology Times. August 20, 2025. Accessed December 9, 2025. https://www.ophthalmologytimes.com/view/the-emerging-era-of-presbyopia-correcting-eye-drops-what-s-next-

7. Harp MD. Lotus submits NDA in South Korea for LENZ’s presbyopia treatment Vizz. Ophthalmology Times. December 2, 2025. Accessed December 9, 2025. https://www.ophthalmologytimes.com/view/lotus-submits-nda-in-south-korea-for-lenz-s-presbyopia-treatment-vizz

8. LENZ launches Vizz for presbyopia in adults. News release. The Ophthalmologist. October 9, 2025. Accessed December 9, 2025. https://www.theophthalmologist.com/issues/2025/articles/october/lenz-launches-vizz-for-presbyopia-in-adults/

9. Harp MD, Maharjan EK. Genentech’s Susvimo receives new FDA indication for diabetic retinopathy. Ophthalmology Times. May 22, 2025. Accessed December 9, 2025. https://www.ophthalmologytimes.com/view/genentech-s-susvimo-receives-new-fda-indication-for-diabetic-retinopathy

10. Khan S, Do CW, Ho EA. Recent updates on drug delivery approaches for improved ocular delivery with an insight into nanostructured drug delivery carriers for anterior and posterior segment disorders. Drug Deliv Transl Res. 2025;15(6):1828-1876. doi:10.1007/s13346-024-01756-x

11. Bairagi RD, Reon RR, Hasan M, et al. Ocular drug delivery systems based on nanotechnology: a comprehensive review for the treatment of eye diseases. Discov Nano. 2025;20(1):75. doi:10.1186/s11671-025-04234-6

12. Cheng H, Wong JLY, Quek CWN, et al. Ophthalmic drug discovery and development using artificial intelligence and digital health technologies. NPJ Digit Med. 2025;8(1):573. doi:10.1038/s41746-025-01954-y