EW Weekly, July 19, 2019

New Drug Application for Bimatoprost Sustained-Release accepted by U.S. FDA
The U.S. FDA has accepted a New Drug Application for Bimatoprost Sustained-Release (Allergan), according to a company press release. If approved, the drug would be the first-in-class sustained release, biodegradable implant to reduce IOP in patients with primary open angle glaucoma or ocular hypertension, Allergan reported. The FDA is expected to take action within the first half of next year.

Allergic conjunctivitis treatment not approved by the FDA
The FDA has not approved EM-100 (Eton Pharmaceuticals), an over-the-counter preservative-free eye drop for ocular itching associated with allergic conjunctivitis. The regulatory agency issued a Compete Response Letter to Eton, and company leaders said they will issue a reply soon. The FDA did not raise any concerns about the application's clinical data, according to a press release from Eton. Bausch Health has the U.S. rights to EM-100.

Money raised by Trefoil Therapeutics to advance eFGF-1 for corneal disease treatment
Trefoil Therapeutics has raised $28 million in oversubscribed Series A financing to help develop engineered fibroblast growth factor-1 proteins (eFGF-1) as a regenerative pharmacologic therapy to treat serious corneal endothelial diseases and epithelial disorders, according to a company press release. The company's lead candidate, TTHX1114, is an engineered form of the FGF-1 protein created to reverse loss of vision by stimulating endothelial cell proliferation and migration. Funding also supports the completion of a Phase 2A proof-of-concept study in corneal endothelial dystrophy. An Investigational New Drug application is slated to be filed in early 2020, with initiation of a clinical trial afterward.

18-month results shared for MIGS treatment MINIject
Stability and sustained performance were observed over 18 months with the MINIject (iSTAR Medical), an implant designed to treat glaucoma. The first-in-human, microinvasive glaucoma surgery STAR-1 trial showed that implantation resulted in a mean IOP of 15 mm Hg at 18 months, consistent with results reported at 1 year. About two-thirds of the patients were able to stop using their eye drops, according to the company.

Dosing begins in Phase 1/2a trial of OpRegen for dry AMD
BioTime has dosed its first patient with the Orbit Subretinal Delivery System (Orbit SDS) as part of its ongoing Phase 1/2a clinical trial for the treatment of dry AMD, according to a company press release. The first patient also has received a new Thaw-and-Inject formulation of OpRegen, BioTime's retinal pigment epithelium transplant therapy. The ongoing study will evaluate the safety and tolerability of OpRegen.

Improvement observed in participants in Orion Visual Cortical Prosthesis study
Twelve-month results from the Early Feasibility Study of the Orion Visual Cortical Prosthesis System (Second Sight Medical Products) were positive, according to a company press release. Orion provides useful artificial vision to those who are blind by converting images captured by a miniature video camera mounted on glasses into a series of small electrical pulses transmitted wirelessly to electrodes implanted directly on the visual cortex. Six subjects have been implanted in the study. Four of the subjects are now 12 months post-implant and are making steady improvements in their ability to perform everyday tasks, company leaders reported. Two of six study participants have experienced an adverse device event, including one seizure and five non-serious adverse events, including a headache.

Research briefs
  • Same-day access to an academic ophthalmology department for ophthalmic concerns appeared to be less costly and took less time than a visit to an emergency department, reported Eric Singman, MD, and coresearchers. Their single-center, retrospective study analyzed the electronic medical record system at Wilmer Eye Institute and the Johns Hopkins Hospital emergency department (ED). Researchers tabulated encounters, charges, and visit length for outpatients seen on the same day or by previously scheduled appointments. The number of same-day access patients who indicated urgency also were tabulated. The mean charge for same-day clinic access was $258, and the mean clinic transit time was 1.55 hours. In the ED, the mean professional fee was $401, and the mean total hospital charge was $1040. At the ED, the mean length of stay was 7.3 hours. Conjunctivitis, corneal abrasion, iritis, and visual loss were the top four ophthalmic diagnoses in the ED. Major savings in time and money might be achieved if urgent eye care takes place in the clinic instead of the ED, the researchers concluded. The study is published in JAMA Ophthalmology.
  • The use of a bandage contact lens soaked in ketorolac 0.45% solution could be a potential drug depot to help reduce pain after transepithelial PRK, reported Rohit Shetty, FRCS, and coresearchers. Their prospective case series separated patients into two groups. In Group 1, a regular soft bandage contact lens was placed after transepithelial PRK. In Group 2, a ketorolac-soaked bandage soft contact lens was placed. Researchers measured pain with the Wong-Baker pain scale. Each group had 35 eyes (35 patients). The mean pain score was 7.95 in Group 1, which was significantly higher than Group 2 (2.76). The use of ultra-high-performance liquid chromatography showed that the soaked bandage contact lens acted as a depot for ketorolac. The research appears in the Journal of Cataract &Refractive Surgery.
  • After a long-term follow-up in adolescents who had accelerated corneal crosslinking, progression was observed in 20% of eyes despite appropriate treatment, reported Muhammet Derda Ozer, MD, and coresearchers. The retrospective review included patients with progressive keratoconus who were age 14 or younger (35 eyes, 23 patients). All patients were followed for at least 4 years after treatment. The mean patient age was 13 years (range, 11 to 14 years), and the mean follow-up was 56 months. At initial presentation, 31% of eyes were classified as stage 1 keratoconus, 40% were stage 2, 23% were stage 3, and 6% were stage 4. Central corneal thickness (CCT) and thickness of the thinnest point of the cornea had decreased significantly compared with preop values at the first year of follow-up. At the second year of follow-up, only thickness of the thinnest point of the cornea was decreased compared with preoperatively. In the last follow-up visit, CCT had increased significantly compared with preop central corneal thickness. Progression was found to be associated with K1, K2, CCT, thickness of thinnest point of the cornea, and age. The study appears in Cornea.
  • Shifting intraocular injections to nurses can be done without increased risk to visual function, according to a randomized, single-masked noninferiority study from Stine Bolme and coresearchers. In the study period, all patients had AMD, retinal vein occlusion, or diabetic macular edema and had intraocular injections at a tertiary ophthalmology department in Norway. Participants were randomized to nurse- or physician-administered intraocular injections of anti-vascular endothelial growth factor. Change in best corrected visual acuity from baseline to 1-year follow-up was the primary outcome measure. A total of 259 patients completed the 1-year follow-up. Intraocular injections performed by nurses were noninferior to physician-administered injections, with 0.7 to 1.6 letters gained, respectively (95% CI of the mean difference, –2.9 to 1.0; P=0.019). The study is published in Acta Ophthalmologica.

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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