Sirolimus looks promising in DME

Article

MacuSight has announced positive interim data from a Phase I study of its proprietary formulation of sirolimus (originally known as rapamycin) for the treatment of chronic, clinically significant diabetic macular oedema (DME).

MacuSight has announced positive interim data from a Phase I study of its proprietary formulation of sirolimus (originally known as rapamycin) for the treatment of chronic, clinically significant diabetic macular oedema (DME).

The randomized, open-label study of 50 subjects with DME was designed to investigate the safety, tolerability and biological activity of sirolimus delivered either by subconjunctival or intravitreal injection. The trial included ten treatment arms with subjects receiving one of five doses.

At 45 and 90 days post-treatment, subjects receiving the two lowest doses by subconjunctival injection showed mean improvements in visual acuity (VA) of 8.5 and 7.4 letters, respectively. This group also demonstrated anatomical improvements, with a mean decrease in foveal thickness consistent with the observed functional improvements in VA.

Preliminary data at 180 days post-treatment, suggests that initial improvements in VA and foveal thickness reductions are maintained or enhanced over time in many patients.

MacuSight has already completed enrolment of a second Phase I trial, which will examine sirolimus in patients with exudative age-related macular degeneration.

Sirolimus is a potent, broad-acting compound that has demonstrated the ability to combat disease through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti-migratory, anti-proliferative, anti-fibrotic and anti-permeability activity.

Newsletter

Join ophthalmologists across Europe—sign up for exclusive updates and innovations in surgical techniques and clinical care.

Recent Videos
Alfredo Sadun, MD, PhD, chief of Ophthalmology at the Doheny Eye Institute, University of California Los Angeles, shared exciting new research with the Eye Care Network during the Association for Research in Vision and Ophthalmology (ARVO) meeting on the subject of Leber hereditary optic neuropathy (LHON).
At this year's Association for Research in Vision and Ophthalmology (ARVO) meeting in Salt Lake City, Utah, Nitish Mehta, MD, shared highlights from his research documenting real-world results of aflibercept 8 mg for patients with diabetic macular oedema.
ARVO 2025: Anat Loewenstein, MD, shares data from herself and her colleagues on meeting needs of patients with diabetic retinopathy
At the American Society of Cataract and Refractive Surgeons annual meeting, Sheng Lim, MD, FRCOphth discusses the benefit of endoscopic cyclophotocoagulation for patients with primary open angle glaucoma and cataracts in the CONCEPT study
A photo of Seville, Spain, with the Congress on Controversies in Ophthalmology logo superimposed on it. Image credit: ©francovolpato – stock.adobe.com; logo courtesy COPHy
Anat Loewenstein, MD, Professor and Director, Department of Ophthalmology, Tel Aviv Medical Center, discusses the Congress on Controversies in Ophthalmology (COPHy)
Anat Loewenstein, MD, speaks about the 22nd Annual Angiogenesis, Exudation, and Degeneration Meeting in February 2025 and shares her global forecast for AI-driven home OCT
Sarah M. Thomasy, DVM, PhD, DACVO, a veterinary ophthalmologist at UC Davis, talks about how her research at the Glaucoma 360 symposium
I. Paul Singh, MD, an anterior segment and glaucoma specialist, discusses the Glaucoma 360 conference, where he participated in a panel discussion on the use of artificial intelligence (AI) in glaucoma care.
Charles Wykoff, MD, PhD, discusses his Floretina ICOOR presentation topic, retinal non-perfusion in diabetic retinopathy, with David Hutton, editor of Ophthalmology Times
© 2025 MJH Life Sciences

All rights reserved.