Ophthalmology in 2025: Year in Review

Plenty of major decisions from the US Food and Drug Administration (FDA) and key trial results have punctuated 2025 for ophthalmology, making it a wildly productive year for the industry. Everything from diabetic retinopathy (DR) to diabetic macular edema (DME) was addressed at some point, with crucial drugs like Susvimo and Acoltremon Ophthalmic Solution receiving approval to enter US markets. Treatment pipelines with Nanoscope and eSight also made significant progress this past year, as detailed in episodes of New Insight with Veeral Sheth, MD.

In light of the sheer number of news releases in 2025, the editorial team at HCPLive has summarized some of the most impactful headlines from throughout the year. Catch up on any bit-ticket stories you may have missed from 2025 below.

FDA News

FDA Approves Susvimo for Diabetic Macular Edema

After this approval was announced on February 4, 2025, Susvimo, a ranibizumab-filled implant formerly known as the Port Delivery System with ranibizumab, became the first FDA-approved continuous delivery treatment for diabetic macular edema (DME). In addition to requiring fewer injections than standard therapy, Susvimo displayed continuous vision improvement in the phase 3 Pagoda study while remaining consistent with its known safety profile. During the trial, patients also received 4 loading doses of intravitreal ranibizumab prior to Susvimo implantation.

FDA Approves Revakinagene Taroretcel (ENCELTO) for MacTel

This March 6, 2025 approval marks the first ever FDA-approved treatment for macular telangiectasia type 2 (MacTel), a neurodegenerative disease of the retina that can cause progressive and irreversible vision loss. Revakinagene taroretcel was designed to deliver continuous therapeutic dosses of ciliary neurotrophic factor to the retina via Neurotech’s encapsulated cell therapy technology. After implantation, the device’s semi-permeable exterior membrane allows nutrients to enter and proteins to travel to the retina.

FDA Approves Susvimo for Treatment of Diabetic Retinopathy

Another major Susvimo approval took place on May 22, 2025, marking it the first and only FDA-approved continuous delivery ttreatment capable of maintaining vision in patients with diabetic retinopathy (DR) – requiring only 1 refill every 9 months. The phase 3 Pavilion study highlighted Susvimo’s superiority to standard-of-care for DR, with roughly 80% of patients on Susvimo achieving a ≥2-step DR severity score improvement by week 100.

FDA Approves Acoltremon Ophthalmic Solution (TRYPTYR) for Dry Eye Disease

On May 28, 2025, the FDA’s approval of acoltremon ophthalmic solution for signs and symptoms of dry eye disease (DED) marked a significant turning point in treating one of the most common ocular surface disorders in the world. The decision was based on positive topline results from the COMET-2 and COMET-3 trials, which displayed acoltremon ophthalmic solution’s superiority to vehicle control. 42.6% of patients in COMET-2 achieved a ≥10 mm increase in unanesthetized Schirmer’s score compared to 8.2% receiving vehicle, and 53.2% of acoltremon patients versus 14.4% of vehicle patients achieved the same in COMET-3.

FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation

Announced on June 12, 2025, the FDA’s approval of prednisolone acetate ophthalmic suspension provides a new salvo against ocular inflammation, a notoriously difficult-to-treat condition due to physiological barriers such as frequent blinking and the tear film. Most commercial eyedrops also have low ocular bioavailability, requiring frequent doses; prednisolone acetate ophthalmic suspension, 1%, is a self-administered eye drop intended for use 2-4 times daily.

Trial Updates and New Guidelines

Intravitreal UBX1325 Shows Efficacy in Diabetic Retinopathy, DME, with Dante Pieramici, MD

The BEHOLD and ASPIRE trials have prominently displayed the safety and efficacy of UBX1325 (foselutoclax), an intravitreal injection targeting cellular senescence to slow the progression of DME and DR. The editorial team at HCPLive spoke with Dante Pieramici, MD, of the California Retina Research Foundation, to discuss the implications of this new gene therapy for common ocular diseases.

Lifitegrast 5% Improves All Biomarkers of Dry Eye Disease, Study Suggests

During a 12-week prospective observational case series study, lifitegrast displayed improvements in all measured clinical biomarkers of dry eye disease (DED) in adult patients. The antagonist of lymphocyte function-associated antigen-1 prevents inflammatory response by blocking this antigen from interacting with intercellular adhesion molecule 1. It also increases goblet cell number and area, as well as tear formation.

Veligrotug Shows Durability for Thyroid Eye Disease in Phase 3 Trial Results

The phase 3 THRIVE trial has highlighted veligrotug’s long-term durability in treating thyroid eye disease. These results came soon after the FDA granted Breakthrough Therapy Designation to the intravenously delivered anti-IGF-1R antibody. Veligrotug has the potential to be the intravitreal treatment of choice for active and chronic thyroid eye disease patients.

Faricimab Rapidly Reduces Retinal Fluid in nAMD in TENAYA and LUCERNE

A post-hoc analysis of the TENAYA and LUCERNE clinical trials highlighted faricimab as exhibiting greater improvements in anatomic outcomes versus aflibercept in patients with neovascular age-related macular degeneration. In both trials, best-corrected visual acuity (BCVA) changes were substantially higher with faricimab compared to aflibercept, as well as effectively extending the time between treatments without sacrificing efficacy.

Faricimab Confirmed Safe for Treatment of Retinal Vein Occlusion

A secondary phase of the BALATON and COMINO trials met their primary endpoints of faricimab noninferiority to aflibercept at week 24, reaffirming faricimab’s efficacy in treating macular edema due to retinal vein occlusion. These sustained increases have not been seen in earlier central or hemiretinal retinal vein occlusion anti-VEGF trials – robust BCVA gains and CST reductions were maintained through all 72 weeks of the study.

Feature Content/Podcasts

New Insight: Restoring Sight With Nanoscope's MCO-010, With Ashish Patel, PhD, MBA

In this episode, host Veeral Sheth, MD, MBA, speaks with Ashish Patel, PhD, MBA, the senior vice president of sales and marketing at Nanoscope Therapeutics, Inc., to discuss the company’s current pipeline in therapeutic devices. The lead program, the MCO-010, is designed to deliver a broadband, highly sensitive opsin to bipolar cells, artificially converting them into surrogate photoreceptors and thereby restoring vision without requiring external goggles or light stimulation.

New Insight: The eSight Go with Roland Mattern, eSight Director of Marketing

In this episode, Sheth spoke with Roland Mattern to discuss the eSight Go, a fifth-generation wearable low-vision device built to enhance central vision function in patients suffering from macular degeneration, diabetic retinopathy, and Stargardt’s disease. Mattern details the history of the company, from its founding to its current pipeline, which aims to help patients with low vision regain mobility and independence.

New Insight: Exploring ENCELTO for MacTel with Rich Small, CEO of Neurotech

In this episode, Sheth spoke with Rich Small, the chief executive officer of Neurotech, about the FDA’s approval of revakinagene taroretcel-lwey for macular telangiectasia type 2. Small details the history of Neurotech, the scientific foundation of revakinagene taroretcel-lwey, and the ideal patient profile for this revolutionary medication. Small also indicated ENCELTO.com, a patient service hub aimed at streamlining diagnosis, treatment, and access to care for patients with macular telangiectasia type 2.

New Insight: A Deep Dive into the Oculis Pipeline with Riad Sherif, MD

In this episode, Sheth met with Riad Sherif, MD, the chief executive officer of Oculis, to discuss the company’s current treatment pipeline in ophthalmic therapeutics. The conversation highlighted OCS-05, a neuroprotective agent which has shown promising results in acute optic neuritis. At the time, the phase 2 ACUITY trial had just been presented, displaying OCS-05’s preservative effects on retinal ganglion cells, which in turn improved low-contrast visual acuity. Additionally, the majority of patients receiving OCS-05 experienced substantially fewer multiple sclerosis relapses, highlighting potentially broader neuroprotective potential.