EW Weekly, September 13, 2019

FDA Biologics License Application and EMA Marketing Authorization completed for abicipar pegol
The U.S. FDA has accepted a Biologics License Application and the European Medicines Agency (EMA) has validated a Marketing Authorization Application for abicipar pegol (Allergan and Molecular Partners), an investigational DARPin therapy for patients with neovascular AMD, according to a press release from the two companies. Action is expected by the FDA on the Biologics License Application in mid-2020, and the European Commission’s decision is expected in the second half of 2020. Both filings are based on data from the Phase 3 trials CEDAR and SEQUOIA, which supported the noninferior efficacy of a quarterly dosing regimen with abicipar pegol to keep vision gains with more than 50% fewer injections versus ranibizumab (13 versus 6 injections) dosed once a month in the first year. DARPin molecules are derived from naturally occurring binding proteins that have repeat sequences with capping structures at the end of each protein.

Phase 3b TALON trial announced to compare two wet AMD treatments
Novartis has announced its initiation of the Phase 3b TALON trial, which will compare its investigational brolucizumab versus aflibercept to treat wet AMD in two primary endpoints. The two endpoints will be superiority for brolucizumab in treatment interval duration and noninferiority in visual acuity change. TALON is a 64-week, two-arm, randomized, double-masked trial that will include an estimated 176 sites and approximately 700 patients. Physicians will use a treat-to-control regimen to allow physicians to extend treatment intervals up to 16 weeks based on response to disease. Trial recruitment is slated to begin this fall, according to the company.

Topline data announced from Phase 1 trial for THR-149 for DME
Topline data from a Phase 1 study with THR-149 (Oxurion) for diabetic macular edema (DME) found that the drug was well-tolerated and safe, the company reported in a press release. There was increasing average improvement in best corrected visual acuity (BCVA) of up to 7.5 letters at day 14 after a single injection of THR-149. At day 90, the average BCVA improvement was 6.5 letters after a single injection. THR-149 is a potent plasma kallikrein inhibitor. The open-label, multicenter, nonrandomized trial focused on the safety of a single intravitreal injection of THR-149 at three ascending dose levels in 12 subjects with visual impairment due to center-involved DME.

Priority review granted by FDA to Graves’ disease treatment teprotumumab
The U.S. FDA has accepted the Biologics License Application for teprotumumab (Horizon Therapeutics) and granted it a Priority Review designation, according to a company press release. If approved, it would be the first FDA-approved medicine to treat active thyroid eye disease, the company reported.

FDA gives Fast Track designation for QR-1123 to treat autosomal dominant RP
The FDA has given a Fast Track designation to QR-1123 (ProQR), a first-in-class investigational antisense oligonucleotide that addresses the underlying cause of vision loss associated with autosomal dominant retinitis pigmentosa due to the P23H mutation in the rhodopsin gene. ProQR leaders will soon begin enrollment for the Phase 1/2 Aurora trial for QR-1123.

Advancing Eyecare acquires Ophthalmic Instruments
Advancing Eyecare has acquired Ophthalmic Instruments, according to a company press release. Both companies are distributors of ophthalmic instruments.  

Research briefs
  • Late IOL calcification was the main reason for IOL explantation in a retrospective study of 200 IOL explants, according to Tabitha Neuhann, MD, and coresearchers. They evaluated explants sent to their lab for patient demographics, implant duration, IOL type, model, power, and reason for explantation. The median time the IOL remained in the eye was 5.8 years. Only 13.5% of the IOLs were explanted because of dislocation. Nearly 84% of the lenses were made with hydrophobic acrylic. There were superficial and subsurface deposits of calcium phosphate in most of the opacified lenses. The study is published in the Journal of Cataract & Refractive Surgery.
  • In a prospective, randomized, parallel group clinical trial comparing the long-term efficacy and safety of two operation methods for late in-the-bag IOL dislocation, both approaches were equally efficient and safe, reported Marius Dalby and coresearchers. Over 3 years, 104 eyes were assigned to either one group for IOL positioning via scleral suturing or for IOL exchange by retropupillary fixation of an iris claw IOL. The main outcome measurement was corrected distance visual acuity (CDVA) at 2 years postoperatively. Sixty-three percent of the patients completed the 2-year follow-up. After 2 years, the mean CDVA was 0.20 logMAR in the repositioning group and 0.22 logMAR in the exchange group. Seventy-six percent of patients achieved a CDVA of 20/40 or better. Twelve percent of eyes had cystoid macular edema in the repositioning group compared with 15% in the exchange group. No endophthalmitis or retinal detachment occurred. The study appears in the American Journal of Ophthalmology.
  • Angle alpha correlated preoperatively and postoperatively with postop vision in patients who received a diffractive quadrifocal IOL in a retrospective longitudinal study, according to Chia-Yi Lee and coresearchers. They included 73 eyes from 73 patients who had diffractive quadrifocal IOL implantation with a follow-up of longer than 6 months and records of wavefront aberrometry within 1 week perioperatively. Corrected distance visual acuity at 1 month postop was significantly better than preop status, with insignificant improvement found at 6 months. Preop Tracey refraction spherical equivalent, angle alpha, and spherical aberration were significantly correlated with postop CDVA and near corrected visual acuity. Tracey refraction spherical equivalent, angle alpha, and spherical equivalent were significantly correlated with CDVA at 6 months postop and near corrected visual acuity; trefoil, internal higher order aberrations, and total higher order aberrations were associated with near corrected visual acuity. The preop angle alpha could predict all postop visual performances, while the postop Tracey refraction spherical equivalent could predict the CDVA at 6 months after surgery and near corrected visual acuity. The research appears in BMC Ophthalmology.
  • Acute endophthalmitis occurred in 0.04% of 8.5 million cataract surgeries in the U.S. from 2013 to 2017, according to data from the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) Registry database. A retrospective cohort study from Suzann Pershing, MD, and coresearchers focused on cases that occurred within 30 days postoperatively. Researchers compared patient characteristics as well as mean and median visual acuity at 1 month before surgery and 1 week and 1 and 3 months after surgery. Endophthalmitis was highest among patients ages 0 to 17 years (0.37% over 5 years), followed by patients ages 18 to 44 years (0.18% over 5 years) (P<0.0001). Endophthalmitis was four times more prevalent in combined cases of cataract with other ophthalmic procedures than standalone cataract surgeries (0.20% versus 0.04%). It occurred in 0.35% of patients receiving an anterior vitrectomy. The mean visual acuity was 20/100 at 3 months postop in patients with endophthalmitis compared with 20/40 among those without endophthalmitis. Four percent of endophthalmitis patients achieved 20/20 or better visual acuity at 3 months, and 44% achieved 20/40 or better. The study is published in Ophthalmology.

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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