nAMD treatment shows promise
Topical integrin inhibitor shows potential therapeutic results in early trial
A novel integrin inhibitor could offer the prospect of treating neovascular age-related macular degeneration (nAMD) with eye drops, reported researchers at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting, in Honolulu, Hawaii.
The drug in question, SF0166 (SciFluor Life Sciences), is a selective small-molecule inhibitor of integrin αvβ3 with physiochemical properties designed to facilitate an ability to reach the retina in high concentrations after topical administration.
Forty-four patients with active subfoveal choroidal neovascularisation and the presence of retinal or sub-retinal fluid participated in a Phase I/II, randomised, double-masked, multi-centre study. The patients self-administered an eye drop containing either 1.25 or 2.5mg SF0166, twice a day for 28 days. They were then followed for an additional 28 days.
Patients were evaluated and followed with spectral domain optical coherence tomography, visual acuity, slit-lamp biomicroscopy, intraocular pressure measurements, fundus photography and fluorescein angiography.
Forty-two of the 44 patients completed the study. Of these, 15 had not been treated previously with anti-VEGF agents. The researchers noted evidence of biologic activity in the form of mean increase in visual acuity and decreases in central retinal thickness and/or fluid seen with spectral domain optical coherence tomography in the 36% of patients that were treatment naive.
POTENTIAL TO REVOLUTIONISE TREATMENT
“This has the potential to revolutionise the treatment of age-related macular degeneration. Topical treatment could increase compliance and possibly prevent vision loss through early intervention. We believe the positive results of this study justify additional clinical study,” Omar Amirana MD, Chief Executive Officer, SciFluor Life Sciences, Inc., Cambridge, US, told EuroTimes.
Treatment responses were seen with both doses. The mean improvement in visual acuity in the treatment-naïve patients was four letters by 28 days. Decreases in central retinal thickness and subretinal fluid of approximately 25 microns were observed.
No serious ocular adverse events were observed. Five patients experienced mild-to-moderate ocular adverse events. One case of dry-eye was considered to be possibly related to the treatment. The study also saw one unrelated, non-ocular serious adverse event, a brachial artery thrombus, and 10 unrelated non-ocular adverse events.
The one-month follow-up suggested a durable response after treatment was discontinued. Additional studies are planned.
Several other potential eye drop treatments for AMD are in development. One of the first, squalamine (Ohr Pharmaceuticals), failed in clinical trials for AMD and has been abandoned. Another, PAN-90806 (PanOptica), a selective inhibitor of VEGF-R2, is in clinical trials. Another agent, KPI-285 (Kala Pharmaceuticals) is in the clinical trial planning stages.