EW Weekly, January 17, 2020

Eye care business from Allergan to be integrated into AbbVie
Upon completion of AbbVie’s acquisition of Allergan, Allergan’s eye care and specialty business will be integrated into the existing AbbVie organization, according to an AbbVie press release. AbbVie also announced the creation of a new business called Allergan Aesthetics that will include BOTOX Cosmetic, JUVEDERM dermal fillers, and other related aesthetic products. The acquisition of Allergan is expected to be complete by the end of first quarter 2020. AbbVie announced its slated acquisition of Allergan in June 2019.

Phase 1b results: Tolerability and IOP lowering among findings with AKB-9778
Tolerability and IOP lowering were among the findings of new results announced from a fifth cohort of patients in a Phase 1b trial with AKB-9778 (Aerpio Pharmaceuticals). The randomized, double-masked trial is focused on evaluating increasing concentrations of AKB-9778 as eye drops. The primary study outcome was ocular safety and tolerability with a change in IOP by day 7. The study’s fifth cohort included 43 patients with ocular hypertension/primary open angle glaucoma on prostaglandin therapy, with the goal of analyzing safety, tolerability, and pilot efficacy of once-a-day AKB-9778 (40 mg/ml) as adjunctive therapy. The study randomized patients 3:1 to receive AKB-9778 (32 subjects) or placebo (11 subjects) in the morning for a week while continuing prostaglandin therapy in the evening. The active arm showed statistically significant decreases in IOP at all administration time points compared with day 1 baseline values. Placebo-corrected results showed a statistically significant decrease in IOP on day 7 and at 0, 4, and 8 hours post-dose compared with placebo. AKB-9778 was well tolerated. In the active treatment arm, 18.8% of subjects experienced hyperemia versus 9.1% of subjects in the prostaglandin-alone arm. AKB-9778 binds to and inhibits vascular endothelial tyrosine phosphatase, which is a negative regulator of Tie2.

First patient dosed with ALY688 for dry eye
The first patient has been dosed in a Phase 1/2a trial for ALY688 ophthalmic solution (Allysta Pharmaceuticals) for dry eye disease, according to a company press release. ALY688 is a peptide agonist that binds to and activates adiponectin receptors that are widely distributed on the ocular surface. After receptor binding, it aims to reduce inflammation and promote healing of injured cells lining the ocular surface, according to the company. Animal models of dry eye disease showed that this led to significant improvement in corneal damage, tear integrity, and tear volume.

Results announced from OPTIC Phase 1 trial of ADVM-022 gene therapy for AMD
Results were announced from the first cohort of patients in the OPTIC Phase 1 trial of ADVM-022 (Adverum Biotechnologies) for wet age-related macular degeneration (AMD). Building on results originally announced in October, the current efficacy and safety data had a median follow-up of 44 weeks (range, 40 to 52 weeks). Among the six patients, researchers found that zero rescue injections were needed, vision remained stable compared with baseline, and anatomic improvements were sustained. The multicenter, open-label, Phase 1 dose-escalation trial focuses on the safety and tolerability of a single intravitreal injection of ADVM-022 in patients who have wet AMD and who are responsive to anti-vascular endothelial growth factor treatment. ADVM-022 uses a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under control with a proprietary expression cassette. ADVM-022 is designed to be a one-time intravitreal injection. The drug has a Fast Track designation from the FDA. In the first half of this year, company leaders plan to submit an Investigational New Drug Application for ADVM-022 to treat diabetic retinopathy.

Pilot study results announced with visual prosthesis for late-stage RP
A pilot study with the BVT Gen2 suprachoroidal visual prosthesis (Bionic Vision Technologies) in four late-stage retinitis pigmentosa patients found improved combined performance in six functional vision tests at 44 weeks of active use of the device, according to a company press release. The 2-year pilot study, underway in Australia, included patients who were unilaterally implanted with the device in the eye with the least amount of vision. Company leaders plan to start a worldwide clinical trial for device commercialization.

New CPT codes for Notal Vision home-based OCT technology
The Current Procedural Terminology (CPT) Editorial Panel created three new Category III codes to report patient-initiated remote retinal OCT scans. This is performed with the use of home-based OCT pipeline technology from Notal Vision, according to a company press release. The new codes are 0604T, 0605T, and 0606T. Notal Vision’s home-based OCT technology received a Breakthrough Device designation from the U.S. FDA at the end of 2018.

CE mark given for STAAR EVO ICL in post-cataract patients
The EVO ICL (STAAR Surgical) received the CE approval mark for use of the ICL as a supplemental lens in cataract surgery patients, according to a company announcement. The approval applies to the EVO/EVO+ and VISIAN Implantable Collamer Lenses for myopia and hyperopia as well as the EVO/EVO+ and VISIAN Toric Implantable Collamer Lenses for myopia and hyperopia with astigmatism.

Make your plans for the 2020 ASCRS Annual Meeting
Registration for the 2020 ASCRS Annual Meeting is open, and registering early is strongly recommended to get the lowest rates and to ensure availability at your preferred hotel. You may also want to consider making travel arrangements to the meeting early to get the best deals during this busy season. More information is available at annualmeeting.ascrs.org.

Research briefs
  • A family history of keratoconus, allergy, asthma, and eczema were the largest risk factors for keratoconus in a systematic review and meta-analysis, according to Hassan Hashemi, MD, and coresearchers. Their review retrieved 3,996 articles and analyzed 29 of them. Among the 29 articles, there were more than 7.1 million participants from 15 countries. Prevalence was 1.38 per 1,000 among the whole population. Prevalence among men was 20.6 per 1,000 and 18.33 per 1,000 in women in studies that reported sex. The odds ratios for eye rubbing, family history of keratoconus, allergy, asthma, and eczema were 3.09, 6.42, 1.42, 1.94, and 2.95, respectively. The study appears in Cornea.
  • There was a limited refractive predictability with the use of wavefront-guided customized treatment with excimer laser in highly aberrated corneas, reported Rana Hanna, MD, and coresearchers. Their retrospective, consecutive, noncomparative case series used the Amaris excimer laser and ORK-CAM software (both Schwind eye-tech-solutions) to calculate the ablation profile. Included eyes were post-refractive and keratoplasty procedures or had high irregular astigmatism with significant high order aberrations (HOAs) that had wavefront-guided customized treatment. A total of 55 treatments in 51 eyes of 35 patients were included. The postop uncorrected distance visual acuity was 0.2 logMAR or better in 72% of eyes. Postop residual manifest refraction spherical equivalent was ±0.50 D in 56% of eyes; 11% lost one line or more of corrected distance visual acuity. Post-hyperopic treatment was associated with a higher rate of refractive surprises. Eyes with preop coma-like aberrations were more likely to benefit from a reduction in HOAs. The study appears in the Journal of Cataract & Refractive Surgery.

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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