EW Weekly, September 18, 2020

First patient dosed in photobiomodulation trial for dry AMD

LumiThera began a prospective, pilot, human clinical trial for its photobiomodulation (PBM) treatment with its Valeda Light Delivery System. The study will evaluate the treatment’s improvement on electroretinogram outcomes in patients with dry AMD, according to a company press release. Patients in the study will receive three treatments per week for 3 weeks and will be followed out to 6 months. Changes in electroretinogram function will be monitored in collaboration with technology from Diopsys. The Valeda Light Delivery System obtained the CE mark to treat dry AMD in 2018, and the company is also investigating its utility in diabetic retinopathy, in addition to continued studies with dry AMD.

First pediatric patient dosed in Phase 3 trial with dexamethasone ophthalmic insert

The first pediatric patient received DEXTENZA (dexamethasone ophthalmic insert, Ocular Therapeutix) 0.4 mg in a Phase 3 trial. The trial is based in the U.S., randomized, and multicenter. According to the company’s press release, it will enroll about 60 patients 0–3 years old who will receive either DEXTENZA at the conclusion of surgery for congenital cataracts or prednisolone acetate suspension eye drops (control). Postop inflammation and pain will be evaluated in the study.

Patient enrollment complete for study of implantable collamer lens

STAAR Surgical announced that it completed patient enrollment of 300 for its FDA clinical trial evaluating the EVO/EVO+ Visian Implantable Collamer Lenses (ICL). The company press release stated that early, 6-month results are expected in the second quarter of 2021 with a submission to the FDA thereafter. The study will evaluate safety and efficacy of these ICLs for myopia and myopia with astigmatism.

Study for novel tumor-targeted therapy for choroidal melanoma sees first patient dosed

Building upon the first cohort of its Phase 2 study for AU-011, Aura Biosciences announced that it dosed its first patient for this novel, tumor-targeted therapy for primary choroidal melanoma. Safety and efficacy of treating the melanoma with AU-011, via suprachoroidal administration, will be assessed as well as dose tolerance. The press release from the company describes the potential for this treatment to be less invasive for early stages of the disease.

Research highlights
  • Using high-speed, phase-resolved OCT in line-field configuration to visualize nanometer/millisecond-scale shape changes, researchers observed in vivo a less than 5-millisecond deformation of human cone photoreceptors when exposed to phototransduction. The authors of this research describe the “biophysical phenomenon” as an “optical manifestation of electrical activity, caused due to the rapid charge displacement following isomerization,” according to the abstract of the study published in Science Advances. A press release about this research described how this “optoretinogram” could help researchers see the effect of gene and stem cell therapies at the cellular level.
  • A prospective, multicenter, open-label study evaluated the effect of lifitegrast ophthalmic solution 5% on tear film, biometry/keratometry readings, and refractive accuracy for cataract surgery patients. The study included 100 eyes of 100 patients who had confirmed dry eye. Baseline biometry data was collected followed by repeat measurements after 28 days on lifitegrast. Biometry reading accuracy for achieved refractive spherical equivalent was within 0.25 D in 47% of eyes prior to treatment and 50% of eyes after lifitegrast treatment; within 0.5 D in 71% of eyes before treatment and 79% of eyes after treatment; and within 0.75 D in 81% of eyes before treatment and 91% after treatment. With this data, the study authors concluded that lifitegrast 5% significantly improved preoperative corneal surface measurement accuracy. The research is published in Clinical Ophthalmology.
  • A single-clinic, unmasked, prospective, non-randomized clinical trial evaluated implantation of an EDOF IOL in one eye and a diffractive multifocal in the other. Thirty-nine total subjects were included. Best-corrected visual acuity of 20/25 or better was achieved in 77% of patients for distance, intermediate, and near, and all patients achieved 20/32 or better at the three distances. According to the study, defocus curves showed a mean continuous vision of 20/25 or better from plano to –2.5 D. All patients in the study achieved spectacle independence for distance, 95% for intermediate, and 70% for near. Most patients said they were bothered “not at all” or only “slightly” by halos (64%) and starbursts (88%). This study is published in Clinical Ophthalmology.

Product news
  • Visible Genomics launched a noninvasive genetic test for AMD.
  • The safety label for Beovu (brolucizumab, Novartis) was approved by the European Medicines Agency to include information about retinal vasculitis and retinal vascular occlusion.
  • Aerie Pharmaceuticals received FDA approval to produce Rhopressa (netarsudil ophthalmic solution) 0.02% in a facility in Athlone, Ireland, for commercialization in the U.S.
  • BVI introduced Patient Packs, which include a face mask, bouffant cap, shoe covers, optional gown, and patient instructions, to help give patients confidence as they return for in-person clinic visits.
  • CYSTADROPS (cysteamine ophthalmic solution, Recordati Rare Diseases) 0.37% is now available for prescription in the U.S. for patients with cystinosis.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor

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