Rapamycin passes 48‑week safety test—what it means for your clinic

1. Senolytics Move From Theory → Real Outcomes

UNITY’s Phase 2b ASPIRE trial reported that a single dose of the senolytic UBX1325 produced vision gains through week 36 comparable to aflibercept in tough‑to‑treat diabetic macular edema.​

Why it matters: It’s the first human evidence that selectively clearing senescent cells can durably remodel tissue—validating UNITY’s “ophthalmology‑first” path and giving clinics a clear IRB conversation starter for future senolytic trials.

2. Rapamycin Shows Year-Long Safety–and Surprising Benefits

The peer‑reviewed PEARL trial (48 weeks, 5–10 mg weekly) found no significant safety signals and a lean‑mass increase plus pain reduction in women on 10 mg.​ A quick note on dosing; this study was performed using compounded rapamycin, which about a third as bioavailable than manufacturer-grade rapamycin, meaning clinicians who want to create similar protocols may need to adjust dosing accordingly. There's discussion in the community as well about whether similar results may not have been found for male participants due to the dose being too low for an effect. Regardless, the safety outcomes are promising given prior concern about rapamycin being traditionally used as an immunosuppressant.

Clinic takeaway: Low‑dose, intermittent rapamycin is looking ever safer for properly screened adults. Start baseline DXA scans and longitudinal labs now so you can contribute real‑world data as dosing guidance tightens.

3. FDA Signals a Faster Lane for AI Devices

Two weeks ago the agency released draft guidance on AI/ML‑enabled medical devices, outlining lifecycle management and streamlined submissions.​

Pair that with brand‑new data on AI‑assisted biomarker segmentation for nAMD, published just 48 hours ago, showing improved precision in tracking disease activity.​

Why it matters: Regulatory clarity plus fresh clinical proof‑points = green light for integrating AI biomarkers (think biological‑age from fundus or blood) into your care pathways. We're keeping a close eye on similar developments for our own R&D.