EyeWorld Weekly Update, April 19, 2019

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April 19, 2019
Volume 24 , Number 15

FDA priority review initiated for wet AMD treatment brolucizumab

The U.S. FDA has accepted the Biologics License Application for brolucizumab (RTH258, Novartis) to treat wet age-related macular degeneration (AMD), according to a Novartis press release. Novartis is using a priority review voucher to speed up the FDA's review. If approved, the drug is slated to launch by the end of this year. The regulatory application for brolucizumab is primarily based on data from the Phase 3 HAWK and HARRIER trails, both of which were global head-to-head trials in wet AMD patients that showed efficacy at week 48, starting with a 12-week dosing regimen. Brolucizumab is a humanized single-chain antibody fragment. Wet AMD gene therapy ADVM-022 on clinical hold The clinical program for ADVM-022 (Adverum Biotechnologies), a gene therapy under evaluation in the OPTIC Phase 1 clinical trial in patients with wet AMD, has been placed on clinical hold per the U.S. FDA. The FDA is requesting additional chemistry, manufacturing, and control information and requirements on the ADVM-022 manufacturing process. Adverum submitted its response last week and is working with the FDA during its review, according to an Adverum press release. Adverum expects to continue patient dosing once the FDA review is completed. First patient dosed in Phase 2/3 ILLUMINATE trial of sepofarsen The first patient has been dosed in the Phase 2/3 ILLUMINATE clinical trial for sepofarsen (ProQR Therapeutics) for patients with Leber's congenital amaurosis 10. Formerly called QR-110, sepofarsen targets the most common p.Cys998X mutation in CEP290 that affects an estimated 2,000 people in the Western world, according to a ProQR press release. ILLUMINATE is a randomized, prospective, double-masked, sham-controlled 24-month trial of sepofarsen slated to enroll 30 adults and children with Leber's congenital amaurosis due to one or two copies of the p.Cys998X mutation in the CEP290 gene. IND submission received for SDP-4 eye drop for dry eye SilkTech Biopharmaceuticals has received clearance for its Investigational New Drug submission with the U.S. FDA for its SDP-4 eye drop, according to a company press release. The company also has begun its Phase 2 trial to assess safety and efficacy of the drop. SDP-4 uses a naturally derived silk protein to treat dry eye. SilkTech's Phase 2 multicenter, double-masked, randomized, vehicle-controlled trial will include 300 patients, with results expected later this year.

Wet AMD gene therapy ADVM-022 on clinical hold

The clinical program for ADVM-022 (Adverum Biotechnologies), a gene therapy under evaluation in the OPTIC Phase 1 clinical trial in patients with wet AMD, has been placed on clinical hold per the U.S. FDA. The FDA is requesting additional chemistry, manufacturing, and control information and requirements on the ADVM-022 manufacturing process. Adverum submitted its response last week and is working with the FDA during its review, according to an Adverum press release. Adverum expects to continue patient dosing once the FDA review is completed.

First patient dosed in Phase 2/3 ILLUMINATE trial of sepofarsen

The first patient has been dosed in the Phase 2/3 ILLUMINATE clinical trial for sepofarsen (ProQR Therapeutics) for patients with Leber’s congenital amaurosis 10. Formerly called QR-110, sepofarsen targets the most common p.Cys998X mutation in CEP290 that affects an estimated 2,000 people in the Western world, according to a ProQR press release. ILLUMINATE is a randomized, prospective, double-masked, sham-controlled 24-month trial of sepofarsen slated to enroll 30 adults and children with Leber’s congenital amaurosis due to one or two copies o

IND submission received for SDP-4 eye drop for dry eye

SilkTech Biopharmaceuticals has received clearance for its Investigational New Drug submission with the U.S. FDA for its SDP-4 eye drop, according to a company press release. The company also has begun its Phase 2 trial to assess safety and efficacy of the drop. SDP-4 uses a naturally derived silk protein to treat dry eye. SilkTech’s Phase 2 multicenter, double-masked, randomized, vehicle-controlled trial will include 300 patients, with results expected later this year.

Ophthotech becomes IVERIC bio, Inc.

Ophthotech Corporation has announced a name change to IVERIC bio, Inc. The name change is part of the company’s transition strategy to focus on discovering and developing new gene therapy solutions to treat orphan inherited retinal diseases with unmet medical needs, according to a company press release.

Independent living an important outcome for glaucoma patients

The ability to maintain independent living was the most important outcome from glaucoma treatment for a group of 45 glaucoma patients who were interviewed, reported Bina Bhaskar Kulkarni, and coresearchers. Their study focused on the clinical and social outcomes that were important to glaucoma patients who were having medical glaucoma treatments or surgery. Patients were recruited for focus group interviews. Social factors were the most important outcomes from glaucoma surgery for patients, including the ability to maintain a driver’s license. Independent living, caring for family, and having a good quality social life were also important. Although patients said they understood the importance of clinical measures, the social outcomes were still important for them. Certainty of a successful outcome and proven longevity of effect were both key for choosing newer surgical treatments, according to the researchers. The study is published in the British Journal of Ophthalmology.

Research briefs

  • The online symptom checker available via WebMD may eventually provide the correct clinical diagnosis for ophthalmic conditions in most cases, but a substantial proportion of diagnoses may not be captured, according to Carl Shen, MD, and coresearchers. Their cross-sectional study used 42 validated clinical vignettes of ophthalmic symptoms and distilled them to their core presenting symptoms. Cases were entered into WebMD’s symptom checker by both medically trained and nonmedically trained personnel who did not know the patient’s diagnosis. A median of 26.8 diagnoses were generated by the symptom check. The primary diagnosis by the symptom checker was correct in 11 of 42 cases. The correct diagnosis was included in the symptom checker’s top three diagnoses in 16 of 42 cases. In 18 of 42 cases, the correct diagnosis was not included. The study appears in JAMA Ophthalmology.
  • Eating fish twice a week, fruit twice a day, and 200 grams of vegetables daily is associated significantly with a reduced risk of AMD, reported APM de Koning-Backus and coresearchers. Their prospective population-based cohort study reviewed 4,202 participants from the Rotterdam Study who were 55 years or older and free of AMD at baseline and followed for about 9 years. Incident AMD was graded via fundus photos, and participants used food frequency questionnaires. A total of 754 people developed incident AMD. Intake of the recommended amounts of vegetables, fruit, and fish were 30.6%, 54.9%, and 12.5%, respectively. Eating fish twice a week was particularly associated with a decreased risk of incident AMD. A younger age, higher income, and nonsmoking status were associated with a healthier food pattern. The study is published in the American Journal of Ophthalmology.
  • A 23-gauge vitrectomy with lens extraction through a corneoscleral limbal incision (CSLI) may have advantages over 23-gauge vitrectomy with phacofragmentation to manage dislocated hard lens nuclei, according to Quan-Yong Yi, MD, and coresearchers. Their retrospective case series included consecutive patients with complete posterior dislocation of a hard nucleus in the vitreous cavity. All patients had 23-gauge, three-channel vitrectomy, while others had phacofragmentation or lens extraction through a CSLI. There were 21 eyes of 21 patients in the CSLI group and 22 eyes of 22 patients in the phacofragmentation group. The median follow-up was 10.8 months. There was a shorter mean surgical time in the CSLI group compared with the phacofragmentation group (42.5 minutes versus 68.2 minutes, respectively). With the CSLI group, there was less frequent use of perfluorocarbon liquid, octafluoropropane, and air tamponade. There also was a lower incidence of retinal tears (9.5% versus 31.8%) and better corrected distance visual acuity. However, there was worse astigmatism at 1 day and 1 week postop. The postop IOP did not differ between the two groups. In the CSLI group, corneal edema and recurrent retinal detachment were less common. The study is published in the Journal of Cataract & Refractive Surgery.

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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