FDA Approves Aflibercept Injection Prefilled Syringe
The US FDA in August approved the aflibercept (Eylea, Regeneron) injection prefilled syringe. The 2-mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer aflibercept that will require fewer preparation steps compared with administration via vial.
The aflibercept prefilled syringe is expected to be available to physicians and patients this year, according to a press release from Regeneron.
In the United States, aflibercept is indicated to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
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Benefit Seen in Subgroups in Phase 2a Study of PlGF Inhibitor
In patients with center-involved diabetic macular edema, no statistically significant difference was observed in mean BCVA in patients who received a combination of the PlGF inhibitor THR-317 (Oxurion) plus ranibizumab (Lucentis, Genentech) compared with patients who received ranibizumab monotherapy, according to 3-month results of a phase 2a study. Patients in the combination therapy arm who had poor baseline vision (BCVA ≤ 65 letters) or a history of nonresponse to anti-VEGF therapy demonstrated improvement compared with the monotherapy group, according to an August press release from Oxurion.
ProQR Will Begin Phase 1/2 Trial of QR-1123 in Patients With Retinitis Pigmentosa
ProQR received clearance from the FDA in August to begin a trial assessing QR-1123, its first-in-class investigational oligonucleotide designed to address the underlying cause of vision loss associated with autosomal dominant retinitis pigmentosa due to the P23H mutation in the rhodopsin gene. Patient enrollment will begin this year.
Nidek Launches Mirante Scanning Laser Ophthalmoscope
The Mirante is a multimodal fundus imaging platform that combines high-definition scanning laser ophthalmoscopy and OCT with ultra-widefield imaging.
CLOUD-BASED TELEMEDICINE PLATFORM MAY CUT UNNECESSARY REFERRALS
Implementation of a cloud-based telemedicine platform could reduce unnecessary referrals from optometrists to ophthalmologists by more than half, according to a retrospective study published in the British Journal of Ophthalmology.
Participating optometrists uploaded clinical data, OCT scans, and 45° color fundus photos centered on the macula to a cloud-based platform for assessment by a consultant ophthalmologist. The main study outcome was reduction of unnecessary referrals among 107 patients over 10 months of observation.
About half of the patients classified into the referral pathway by the optometrist were deemed by the ophthalmology specialist not to require referral. Fourteen patients, 86% of whom experienced vision loss, were designated as urgent, and 35 patients, 37% of whom experienced vision loss, were designated as routine referrals by the reviewing ophthalmologist.