EW Weekly, October 12, 2018

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October 12, 2018
Volume 24 , Number 38

Phase 3 trial begins for OCU310 for dry eye

A Phase 3 trial is underway for OCU310 (Ocugen, Malvern, Pennsylvania) for patients with dry eye disease, according to a company press release. OCU310 is an investigational, twice-daily, steroid-free, preservative-free eye drop of brimonidine tartrate 0.2% that is formulated with OcuNanoE, the company's proprietary nanoemulsion technology. Ocugen is conducting two identical placebo-controlled Phase 3 trials with about 240 patients per study. The efficacy and safety results will be analyzed after 28 days of treatment. The trials' primary endpoints will be the change from baseline to 4 weeks in Symptom Assessment in Dry Eye score and in lissamine green conjunctival staining scores after 4 weeks. Topline data from the trials are expected in the second half of 2019.

EMA receives Marketing Authorization Application for Rhokiinsa

The European Medicines Agency (EMA) received the Marketing Authorization Application for Rhokiinsa 0.02% (netarsudil ophthalmic solution, Aerie Pharmaceuticals, Durham, North Carolina). In the U.S., the agent is currently marketed as Rhopressa and is indicated to reduce elevated in IOP in patients with open-angle glaucoma or ocular hypertension. An opinion from the EMA regarding Rhokiinsa is expected in the second half of 2019, Aerie reported in a press release.

Treatments for inherited retinal diseases to be developed by Wave Life Sciences

Wave Life Sciences Ltd. (Cambridge, Massachusetts) announced plans this week to design and advance stereopure oligonucleotide therapeutics to treat rare, inherited eye diseases including retinitis pigmentosa due to a P23H mutation in the RHO gene, Usher syndrome type 2A, Stargardt disease, and Leber congenital amaurosis 10. The company said in a press release that it will announce its first ophthalmology development candidate in the second half of 2019. Company leaders decided to expand the therapeutic pipeline into ophthalmology based on data presented earlier this month demonstrating that a single intravitreal injection of stereopure oligonucleotide in the eye of non-human primates had a greater than 95% knockdown of a target RNA in the retina for at least 4 months. "Based on these data, the company is working to design development candidates that could achieve a therapeutic effect with only two doses per year," according to the press release.

Brolucizumab shown to reduce retinal fluid in Phase 3 data study

In a Phase 3 study, retinal fluid was detected less often in patients treated with brolucizumab 6 mg (RTH258, Novartis, Basel, Switzerland) compared with aflibercept over four visits between weeks 36 to 48, according to a company press release. The data are from the Phase 3 HAWK and HARRIER trials that focus on patients with neovascular age-related macular degeneration and reflect prespecified secondary endpoints. "The 36- to 48-week analysis is noteworthy because it provides insight in to the effect of maintenance treatment," according to the press release. Brolucizumab is a humanized single-chain antibody fragment. Regulatory submissions for brolucizumab are on track for December 2018.

Abstract submissions for the 2019 ASCRS Annual Meeting close next week

Help shape the ASCRS program and get the chance to present to your colleagues at the 2019 ASCRS Annual Meeting by submitting your abstracts for instructional courses, scientific papers, posters and films. The programming featured every year is developed by anterior segment surgeons for anterior segment surgeons. Be counted among 2019's outstanding presenters! Detailed information is now available on the Call for Submissions website. Please read the 2019 ASCRS Annual Meeting Submission Guide before submitting your abstract. The deadline to submit abstracts for instructional courses, scientific papers, posters, and films is next Wednesday, October 17. All ASCRS program faculty are required to register for the Annual Meeting. You can book your hotel now, and registration will open on Monday, October 15. We look forward to seeing you in San Diego!

Vision Ophthalmology Group acquires MED Medical Products GmbH

Vision Ophthalmology Group (Frankfurt, Germany) has acquired MED Medical Products GmbH (Karlstein, Germany), a specialist producer of customized procedure packs and disposable products.

Research briefs

  • Cataract surgery is associated with a modest reduction in a patient's subsequent risk of a serious traffic crash as a driver, according to Matthew B. Schlenker, MD, MSc, FRCSC, and coresearchers. Their population-based study of 559,546 patients included those who received cataract surgery in at least one eye and who were age 65 or older. The main outcome was emergency department visits for a traffic crash as a driver. There were a total of 4,680 traffic crashes (2.36 per 1,000 patient-years) accrued during the 3.5-year baseline interval and 1,200 traffic crashes (2.4 per 1,000 patient-years) during the 1-year subsequent interval. This represented 0.22 fewer crashes per 1,000 patient-years post-cataract surgery. Younger patients, those with a history of crashes, those with more emergency visits, and those with frequent outpatient physician visits had a higher risk of traffic crashes. The study is published in JAMA Ophthalmology.
  • Nanothin Descemet stripping automated endothelial keratoplasty (NT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) have comparable visual outcomes and complication rates, according to Khaliq Kurji, MD, MSc, FRCSC, and coresearchers. They analyzed a prospective case series of 28 consecutive cases of NT-DSAEK (less than or equal to 50 microns) and DMEK. Fuchs' dystrophy, pseudophakia, or planned combined cataract surgery/endothelial keratoplasty were among the inclusion criteria. The primary outcome measures were best spectacle-corrected visual acuity (BSCVA) and complications. The mean thickness of NT-DSAEK grafts was 41 microns (range, 26 to 50 microns). At 1 month post-surgery, the DMEK group had a significantly better mean BSCVA of 0.18 logMAR (20/33) compared with 0.28 logMAR (20/40) for NT-NSAEK (P= 0.049). The mean BSCVA was comparable between both groups at 3, 6, and 12 months. No complications occurred except for a DSAEK graft that was successfully rebubbled. The research appears in Cornea.
  • The safety and efficacy of IBI-10090 anterior chamber intracameral dexamethasone drug-delivery suspension (Dexycu, EyePoint Pharmaceuticals, Watertown, Massachusetts) was similar to that of prednisolone 1%, according to the results of a prospective, randomized, open-label, multicenter trial, reported Eric D. Donnenfeld, MD, and coresearchers. In the study, patients were randomized 2:1 to receive a 5-microliter injection of 517 micrograms of IBI-10090 in the anterior chamber or one drop, four times daily of topical prednisolone for 3 weeks. Researchers analyzed safety by the incidence and severity of adverse events. Among the 126 IBI-10090 and 55 prednisolone patients, there was no significantly different decrease in endothelial cell density between the groups. An increased IOP (11.1%), iritis (6.3%), and systemic effects (7.9% for the IBI-10090 group and 10.9% for the prednisolone group) were the most common adverse events. Anterior chamber cell clearing occurred by 8 days post-op in 51.6% of the IBI-10090 patients and 50.9% of prednisolone eyes. At 90 days, more than 98% of eyes had clearing. Nearly 69% of IBI-10090 patients strongly agreed that not having to use eyedrops was very convenient. The study is published in the Journal of Cataract & Refractive Surgery.
Product news
    The RightEye LLC (Bethesda, Maryland) has received 510(k) clearance from the U.S. Food and Drug Administration to record, view, and analyze eye movements in support of identifying visual tracking impairment in patients.

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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