Ophthalmology Month in Review: March 2025

March was a notable month for ophthalmology, with first-time regulatory approvals and independent studies advancing the future of eye care. The US Food and Drug Administration (FDA) approved the first-ever treatment for Macular Telangiectasia (MacTel) type 2 and granted Fast Track designation to a first-of-its-kind spreading capsid treatment for X-linked retinoschisis (XLRS).

However, regulatory momentum stalled when sozinibercept trials failed to achieve their primary endpoint, when the treatment was unable to provide superior results to aflibercept monotherapy.

New knowledge came to light that the COVID-19 lockdowns of 2020-2022 had devastating impacts on pediatric ocular health. Myopia and astigmatism both rose among the youth of Hong Kong, specifically due to corneal damage caused by near-work. Another study detailed the impacts of combined air, suggesting their debilitating effects on an individual’s chances of degenerative diseases.

Here’s a recap of what happened in ophthalmology in March:

FDA Approves Revakinagene Taroretcel (ENCELTO) for MacTel

Early in the month, the FDA announced its approval of revakinagene taroretcel-lwey (ENCELTO), formerly known as NT-501, for treatment of Macular Telangiectasia type 2 (MacTel). Neurotech’s cell-based gene therapy system, which is designed to continuously deliver doses of ciliary neurotrophic factor using the company’s encapsulated gel therapy technology, became the first and only FDA-approved MacTel treatment in history.

FDA Awards Fast Track Designation to ATSN-201 Gene Therapy for XLRS

The FDA also granted Fast Track designation to Atsena Therapeutics’ X-linked retinoschisis treatment ATSN-201. The company’s novel spreading capsid treatment is actively being tested in Part B of the LIGHTHOUSE trial, which will observe patients off-therapy for a year before offering ATSN-201 for treatment.

Sozinibercept for Wet AMD Misses Primary Endpoint in Phase 3 COAST Trial

Opthea’s ill-fated sozinibercept combination therapy failed to achieve its primary endpoint in Phase 3 of the COAST trial. The first-in-class vascular endothelial growth factor (VEGF) C/D “trap” fusion protein exhibited mean best-corrected visual acuity improvements below that of aflibercept monotherapy.

Higher Astigmatism Rates Found in Children after COVID-19 Pandemic

A study towards the end of March indicated that COVID-19 and the ensuing lockdown had a debilitating effect on refractive and corneal astigmatisms in children. The amount of time spent in front of screens or engaged in near work has caused a drastic uptick in both forms of astigmatism every year since the initial lockdown in 2020.

Weight-Adjusted Waist Index Successfully Predicts Macular Degeneration

Another study revealed that the weight-adjusted waist index, a tool commonly used for determining diabetes and hypertension, can also be used to predict age-related macular degeneration. Additionally, the index may be a more accurate predictor than BMI, as it circumvents the issue of distinguishing between fat and muscle mass.

Joint Air Pollutant Exposure Linked to Eye Disease

A prospective cohort study from Hong Kong indicated that compounding pollutant exposure directly correlates to a higher risk of ocular disease, such as AMD and cataract. Given that there are no existing methods for measuring combined pollutants, this study puts forward the importance of adapting to the impacts of the changing environment.