Q3 2025 Recap: Ophthalmology News and Updates

The third quarter of 2025 saw a slew of critical trial results, from investigating treatment interval extension in diabetic macular edema (DME) to providing alternative treatment methods for difficult diseases like Stargardt Disease, and a handful of promising approvals from the US Food and Drug Administration (FDA).

The US Food and Drug Administration (FDA) approval of aceclidine in July 2025 provided a safe and effective method for treating presbyopia, and the acceptance of reproxalap’s New Drug Application (NDA) for dry eye disease (DED) may finally provide patients with a promising new solution for an extremely common condition.

Additionally, clinical trials like VERONA, QUASAR, BEHOLD, and ASPIRE have presented promising new therapies for diabetic retinopathy (DR), DME, and neovascular age-related macular degeneration (nAMD). The field of intravitreal implants is also expanding with the improvement of ocular health by the EYP-1901 and PER-100 implants.

The editorial team at HCPLive has collected some of the most impactful headlines from Q3 of 2025 – check them out below:

FDA Decisions

FDA Approves Aceclidine (VIZZ) for Presbyopia in Adults

Aceclidine ophthalmic solution, the first and only FDA-approved aceclidine-based eye drop for presbyopia, received its approval on July 31, 2025. The solution primarily interacts with the iris, contracting the sphincter muscle to create a pinhole effect in the pupil, thereby extending the depth of focus and improving near vision without inducing a myopic shift. According to parent company LENZ Therapeutics, samples are expected to arrive in the US in October 2025, and the commercial product is anticipated to be available in mid-2025.

FDA Accepts Reproxalap Application for Dry Eye Disease

On July 17, 2025, parent company Aldeyra Therapeutics announced the acceptance of reproxalap’s NDA for DED. The first-in-class small molecule modulator of RASP achieved its primary endpoint in a phase 3 randomized, double-masked dry eye chamber trial compared to vehicle, assessing its efficacy in reducing ocular discomfort. The FDA has set an expected PDUFA date for December 16, 2025.

Trial Updates

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

Data from the BEHOLD and ASPIRE phase 2 and 2b trials indicated the efficacy of senolytic small molecule inhibitor of anti-apoptotic protein BCL-xL UBX1325 in limiting the impact of DME and DR. Presented at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists, these data showed that 53% of patients receiving UBX1325 did not require anti-VEGF rescue at any point during the trial, compared to 22% in the sham subgroup. BEHOLD also saw patients receiving UBX1325 stabilized or improved their central subfield thickness.

Gildeuretinol Shows Lasting Visual Improvements in Stargardt Disease, with Kenneth Fan, MD, MBA

Another presentation at ASRS 2025 highlighted the ongoing TEASE-3 trial, investigating gildeuretinol’s disease-slowing capabilities in Stargardt Disease. Among the 5 patients who had completed the trial in July 2025, best-corrected visual acuity (BCVA) showed little to no decline over the entire 24-month trial period. Additionally, gildeuretinol was well-tolerated, with only 1 treatment-emergent adverse event designated as severe.

VERONA Meets Primary Endpoint of Time to Supplement in DME, with Yasha Modi, MD

The phase 2 VERONA study saw investigational intravitreal injection EYP-1901, a sustained-release tyrosine kinase inhibitor insert, achieve extended time to first supplement versus aflibercept in DME. Presented at ASRS 2025, these data have helped to open the floodgates of treatment extension across ophthalmology. Patients with DME have long relied on anti-VEGF therapies, requiring repeated injections and presenting a severe treatment burden. EYP-1901 could significantly reduce that burden by providing an alternative to frequent injections.

PER-001 Implant Safely Improves Ocular Health in Patients with DR

Another intravitreal implant presented at ASRS 2025, PER-001, a first-in-class, sustained-release implant delivering an endothelin A receptor agonist, has proven itself safe and well-tolerated in patients with DR. PER-001 led to more significant improvements in ultra-widefield fluorescein angiography and low luminance and low contrast visual acuity compared to sham.

Aflibercept 8 mg Maintains Long-Term Visual Improvement in Diabetic Macular Edema

The ongoing phase 3 QUASAR trial comparing aflibercept 8mg to 2mg has shown significantly higher BCVA improvement in DME secondary to retinal vein occlusion in the higher dose. Patients assigned to the higher dose also achieved this improvement with fewer injections, highlighting the 8mg dose’s capacity for reducing the treatment burden for DME. Aflibercept 8mg also exhibited a safety profile consistent with that of aflibercept 2mg throughout the trial.

OPTIC and LUNA Suggest Long-Term Efficacy of Ixo-Vec in nAMD, with Sean Adrean, MD

Both the OPTIC and LUNA trials highlighted the safety and efficacy of Ixo-vec in maintaining visual and anatomic endpoints in patients with nAMD, thereby reducing the injection burden for patients who had previously required frequent anti-VEGF injections. This investigative gene therapy, composed of the AAV.7m8 capsid, which is derived from in vivo directed evolution for enhanced transduction of retinal cells. This allows it to provide sustained aflibercept expression after a single injection.