EyeWorld Weekly Update, November 30, 2018

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November 30, 2018
Volume 24 , Number 46

Clinical study initiated for IC-8 lens for cataract patients

An Investigational Device Exemption has been approved by the U.S. Food and Drug Administration (FDA) for a pivotal study of the IC-8 small aperture IOL (AcuFocus, Irvine, California) for cataract patients. The IOL is a clear monofocal lens with an embedded mini-ring in the center, according to a company press release. The prospective, multicenter, parallel-group study will demonstrate the extended depth of focus achieved with the IC-8 compared with traditional monofocal IOLs. AcuFocus will enroll an estimated 475 patients with bilateral cataracts, and participants will be followed for 12 months.

Initial patient enrolled for Phase 3 trial of mydriasis

The first patient has been enrolled in one of two Phase 3 trials that will focus on the MicroStat (Eyenovia, New York) program for pharmacologic mydriasis. The trials, MIST-1 and MIST-2, will investigate the safety and efficacy of the Eyenovia's fixed-combination phenylephrine 2.5%/tropicamide 1% ophthalmic solution, which is given as a microdose using an Optejet dispenser. The two studies are randomized, double-blind, and multicenter superiority, and each will enroll about 65 participants in the U.S. Both eyes of patients in the MIST-1 study will be treated on separate days with the company's solution; in MIST-2, participants will receive the company's fixed-combination mydriatic solution and a placebo on separate days. Both studies will have a primary endpoint of mean change in baseline pupil diameter at 35 minutes after study treatment is administered.

Photrexa drug formulations receive permanent J code

The Centers for Medicare and Medicaid Services issued a product-specific J code for Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution, Avedro, Waltham, Massachusetts). The new J code is J2787. The code will be effective on Jan. 1.

Results announced with Ocular Bandage Gel for punctate epitheliopathy, PRK

Top-line data from two studies, one focused on the Ocular Bandage Gel (EyeGate Pharmaceuticals, Waltham, Massachusetts) for punctate epitheliopathies and the second on the Ocular Bandage Gel for corneal epithelial defects in patients after PRK, were announced earlier this month. In the punctate epitheliopathy study, 30 subjects were enrolled, all of whom had pathologies such as dry eye; the Ocular Bandage Gel was compared to a commercially available rewetting drop. Corneal fluorescein staining and symptomology at days 7, 14, and 28 were assessed. The Ocular Bandage Gel eye drops led to statistically significant improvement by day 7 and at day 28. In the PRK study, 45 subjects having bilateral PRK were enrolled. The trial compared two dosing regimens of the bandage gel to current standard use of a bandage contact lens and artificial tears. The percentage of subjects who had complete wound healing at days 3 and 4, as well as wound size on day 3, were the assessments used. Both bandage gel dosing regimens outperformed standard of care in the number of eyes healed at days 3 and 4. The PRK study was a replication of a previous EyeGate study. The data likely will lead to regulatory filings for approvals, according to a company press release.

First patient dosing in Phase 1 trial of ADVM-022 gene therapy in wet AMD

The first patient was dosed recently in the Phase 1 OPTIC trial that is evaluating ADVM-022 (Adverum Biotechnologies, Menlo Park, California) for patients with wet age-related macular degeneration (AMD). The multicenter, open-label, Phase 1 dose-escalation trial will assess the safety and tolerability of a single intravitreal administration of ADVM-022 in patients with wet AMD who are responsive to anti-vascular endothelial growth factor treatment. The trial is slated to enroll 18 patients and will evaluate three doses of ADVM-022. Patients will receive a tapering prophylactic corticosteroid regimen. The safety and tolerability of ADVM-022 at 24 weeks after a single intravitreal administration will be the primary endpoint. ADVM-022 uses a proprietary vector capsid that carries an aflibercept coding sequence under the control of a proprietary expression cassette and is administered as a single intravitreal administration. In September, Adverum received a Fast Track designation from the FDA for ADVM-022 for wet AMD.

RESEARCH BRIEFS

  • In individuals susceptible to other biological oxidative stressors, exposure to ambient black carbon may be a risk factor for increased IOP, according to J.C. Nwanaji-Enwerem and coresearchers. They conducted a population-based analysis in men participating in the Normative Aging Study of the U.S. Department of Veterans Affairs. Their research included 419 older men and 911 total follow-up study visits between 2000 and 2011. The mean 1-year black carbon exposure was 0.51 micrograms/m3; mean IOP was 14.1 mm Hg in both eyes. During the follow-ups, 57% had a high endothelial function allelic risk score, 70.7% had a high metal-processing allelic risk score, and 68.4% had a high oxidative stress allelic risk score. The association of black carbon with IOP was larger in those with a high oxidative stress allelic score compared with those who had a low score. If additional studies confirm the results, monitoring for ambient black carbon exposure could prevent the development and progression of IOP-related disease, the researchers concluded. The study appears in JAMA Ophthalmology.
  • When measuring the precision of IOL power prediction in eyes shorter than 22 mm, the Barrett Universal II, Haigis, Hoffer Q, Holladay 2, RBF method, and SRK/T formulas all were equally accurate, according to Ankur Shrivastava, MS, and coresearchers. Their retrospective observational study of 50 eyes of 50 patients analyzed the six previously mentioned formulas in eyes shorter than 22 mm. They defined the mean numerical error as the difference between the actual postop spherical equivalent at the 1-month follow-up and the predicted postop spherical equivalent. The median absolute error was calculated and compared among the six formulas after zeroing of the mean numerical error by adjusting the lens constant individually for each formula. Post-hoc analysis and Bonferroni correction for multiple comparisons showed no significant statistical differences among the formulas, according to the researchers. The study is published in the Journal of Cataract & Refractive Surgery.
  • In a retrospective study comparing visual outcomes and intraop complications of phaco surgery after prior pars plana vitrectomy, there was significant visual acuity improvement with post-vitrectomy cataract surgery. However, there was a worse mean postop vision of 0.2 logMAR units when compared with eyes without prior PPV, reported Mohamed Kamel Soliman, MD, and coresearchers. In the 2,221 eyes in the prior PPV group, eyes with worse preop logMAR visual acuity were from younger patients and tended to have longer axial lengths than the non-vitrectomized group. The mean vision in the prior PPV group was poorer at all postop time points up to 24 weeks. The rate of posterior capsule rupture was not different between the prior PPV group and the non-vitrectomized group. However, zonular dialysis and dropped nuclear fragments occurred more frequently in the PPV group. The study is published in Ophthalmology.
  • In 11 cases of sporadic Creutzfeldt-Jakob disease, all patients had detectable prions in the eye, reported CD Orrù and coresearchers. In some patients, the seed levels in the retina approached those in the brain. Prion deposits also could be seen via immunohistochemical retinal tissue staining, although other ocular tissues were negative. The results have implications for estimating the risk for iatrogenic transmission of sporadic Creutzfeldt-Jakob disease and for the development of antemortem diagnostic tests for prion diseases, the researchers concluded. The research is published in MBio.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, 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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