At the European Society of Retina Specialists (Euretina) Congress in Paris, Ashvattha Therapeutics reported that its investigational drug migaldendranib (formerly D-4517.2) significantly reduced the need for intravitreal injections in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) in a phase 2 trial.

The 40-week multicenter trial evaluated subcutaneous migaldendranib, a nanomedicine designed to cross the blood-retinal barrier and selectively normalize VEGF expression in areas of retinal inflammation. Patients enrolled had previously been treated with intravitreal anti-VEGF therapy. According to data reported at Euretina, annualized injection rates fell from 8.4 to 1.6 in study eyes and from 8.3 to 0.9 in fellow eyes, representing reductions of nearly 80% and 90%, respectively. Participants also demonstrated improvements in visual acuity, gaining an average of 6.1 ETDRS letters in DME eyes, along with reductions in central subfield thickness. Similar gains were observed in nAMD eyes.

No treatment-related systemic or ocular serious adverse events were reported. Improvements were also observed in retinal anatomy, with reductions in central subfield thickness. The results suggest that monthly, at-home subcutaneous administration of migaldendranib could provide a less burdensome alternative to frequent in-office intravitreal injections. Further studies will be needed to confirm safety and efficacy prior to regulatory approval. RP