
OR WAIT null SECS
Catch up on the groundbreaking FDA approvals, key trial updates, and more news from the last month.
After a relatively quiet September, ophthalmology enjoyed a series of key approvals from the US Food and Drug Administration (FDA) and important trial results during October 2025.
Between adalimumab-aaty’s expanded indication for pediatric patients and epioxa’s approval for keratoconus, underrepresented and undertreated diseases have received renewed regulatory attention. A post-hoc analysis of the KINGFISHER trial also displayed the efficacy of brolucizumab in diabetic macular edema (DME), opening another treatment pathway for the disease.
With so many updates throughout the last month, the editorial team at HCPLive has collected 6 of the most important headlines in ophthalmology from October. Check them out below.
Announced on October 20 by parent company Glaukos Corporation, this approval was based on 2 pivotal phase 3 trials showing statistically significant improvements in maximum corneal curvature at 12 months. This approval provides clinicians with another potential treatment pathway for keratoconus, a disease otherwise requiring invasive surgery with significant pain and extended healing times.
Announced by parent company Celltrion on October 17, the FDA’s decision expands adalimumab-aaty’s primary indication for rheumatoid arthritis, Crohn’s disease, and plaque psoriasis – among other conditions – to uveitis and hidradenitis suppurativa in patients ≥2 years of age and ≥12 years of age, respectively. The company offers adalimumab-aaty in both branded and unbranded versions, with 2 pricing options to meet various patient needs and improve affordability.
A post-hoc analysis of the KINGFISHER trial has shown the superiority of brolucizumab 6 mg compared to aflibercept 2 mg in treating DME irrespective of prior anti-VEGF treatment. Changes in best-corrected visual acuity and in central subfield thickness were consistently higher among the patients assigned to brolucizumab compared to aflibercept, highlighting an anatomical advantage.
A secondary analysis of the J-DOIT3 study has spotlighted a potential association between higher HbA1c, nonsevere hypoglycemia, and a higher risk of onset of diabetic retinopathy in patients with type 2 diabetes. This association exists even after achieving good glycemic management with a low incidence of severe hypoglycemia, indicating the importance of strict glycemic management.
A recent study has found a significant association between macular hole healing and total cholesterol and triglycerides, which indicates a potential link between dyslipidemia and macular hole recovery. However, the study’s retrospective nature led investigators to call for further research, looking to elucidate the specific mechanisms linking the 2 factors.
Although this study was unable to determine a direct correlation, the comparison of GLP-1 RAs and other weight-loss drugs showed a risk reduction for nonexudative age-related macular degeneration (AMD) in the former. After a follow-up of ≤10 years, investigators saw an association between GLP-1 RAs and a decreased risk of developing nonexudative AMD at 5, 7, and 10 years. Moreover, patients taking no weight loss medication had a higher risk of progressing to exudative AMD.
Related Content: