EW Weekly, June 14, 2019

Phase 1B trial underway for POAG agent AKB-9778
Aerpio has dosed its first subject in a Phase 1B trial of AKB-9778, an ocular formulation developed to treat primary open angle glaucoma, the company announced. The double-masked, multiple-ascending dose trial will enroll four cohorts of 12 subjects who will receive increasing daily doses of the ocular formulation or a placebo for 7 days. The trial's endpoint will be ocular safety and tolerability; IOP lowering will be the key pharmacodynamic endpoint. AKB-9778 binds to and inhibits vascular endothelial protein tyrosine phosphatase, which is a negative regulator of Tie2. Lowered Tie2 activity contributes to vascular instability in many diseases, including diabetes, according to Aerpio.

First patient enrolled in Phase 3 study for progressive myopia
The first patient has been enrolled in Eyenovia's CHAPERONE study, which is its MicroPine Phase 3 program, according to a company press release. The U.S.-based, multicenter, randomized, double-masked study will include more than 400 children from 3 to 12 years old and investigate the safety and efficacy of MicroPine to reduce progressive myopia with the company's proprietary atropine topical microformulation delivered by the Optejet dispenser.

FDA approves PRK pivotal study
The U.S. FDA has approved the initiation of a PRK pivotal study led by EyeGate Pharmaceuticals, according to a company press release. EyeGate will begin enrollment soon and should have topline results by the end of the year. The company's OGB platform, if approved, will be the first prescription hyaluronic acid eyedrop formulation in the U.S. market, according to EyeGate.

First patient dosed in second cohort of Phase 1 trial for ADVM-022 gene therapy for wet AMD
The first patient has been dosed in the second cohort of the ongoing OPTIC Phase 1 trial for ADVM-022 for the treatment of wet age-related macular degeneration (AMD). In the trial, patients receive a single intravitreal injection of the gene therapy candidate ADVM-022 at a dose of 2 x 10^11 vg/eye. OPTIC is a multicenter, open-label, dose-escalation trial to assess the safety and efficacy of a single intravitreal administration of ADVM-22 in patients with wet AMD who are responsive to anti-vascular endothelial growth factor (VEGF) treatment. 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.

THR-317 for DME safe and well-tolerated in Phase 1/2 study
A Phase 1/2 study of THR-317 (Oxurion) for diabetic macular edema met its primary endpoint of safety at both 4 mg and 8 mg doses, reported Anat Lowenstein, MD. The Phase 1/2 study included 49 patients, some of whom were anti-VEGF naïve and others who were suboptimal anti-VEGF responders. Patients receiving the 8 mg dose of THR-317 had better visual acuity outcomes than the 4 mg dose group. A Phase 2 study of 8 mg of THR-317 in combination with ranibizumab is ongoing.

Three-year follow-up data for ILUVIEN in recurrent noninfectious uveitis announced
Three-year follow-up data from a Phase 3 clinical trial of the ILUVIEN (Alimera Sciences) 190 micrograms intravitreal implant had positive results, according to a company press release. The study focused on prevention of relapse in recurrent noninfectious uveitis. Median time to the first recurrence of noninfectious uveitis was significantly longer in the ILUVIEN arm of the trial (657 days) compared with the control sham arm (70.5 days; P 0.001). The number of uveitis recurrences was significantly lower in the ILUVIEN arm (1.7) versus the sham arm (5.3) over the 3-year period. There was also better improvement from baseline of best corrected visual acuity and a lower rate of surgery to reduce severe IOP. The data will support the company's planned European launch of the drug for noninfectious uveitis affecting the posterior segment in the second half of this year.

Register now for the June 26 ASCRS webinar "Management of Dislocated IOLs and Secondary IOL Placement: Yamane Technique Pearls"
Physicians can learn more about intrascleral haptic fixation, IOL exchange, and the Yamane technique in the upcoming webinar “Management of Dislocated IOLs and Secondary IOL Placement: Yamane Technique Pearls,” sponsored by the ASCRS Cataract Clinical Committee.
Register now and join experts Nicole Fram, MD, Brandon Ayres, MD, Steve Safran, MD, and Mitchell Weikert, MD, on June 26 at 9:00 p.m. ET to hear them discuss the advantages, limitations, and pearls related to this technique.
The webinar will be captured and available on the ASCRS Center for Learning at ascrs.org afterward.

Research briefs
  • An increased risk for intraop or postop complications after phacoemulsification was found in eyes with previous herpes zoster-related keratitis, according to a study from Lucy Lu, MB ChB, and coresearchers. Their retrospective case series focused on intraop and postop complications, postop visual acuity, and recurrent disease in eyes with herpes zoster-related keratitis and/or uveitis. Among the 57 eyes of 57 patients included, 66.7% had recurrent disease before cataract surgery. There were intraop complications in 14% of patients, including posterior capsule tear in 3.5% of patients. An IOP of 30 mm Hg or higher was seen in 3.5%, and central corneal edema occurred in 14%; all resolved within a month. Additionally, cystoid macular edema occurred in 3.5% of patients. At 12 months, the median corrected distance visual acuity was 20/40. Herpes zoster recurred in 40.4% of patients after surgery, and a higher risk for recurrence was associated with shorter periods of quiescence and a greater number of recurrences before surgery. Because of disease severity, one eye was eviscerated. Consideration should be given to maximizing the period of quiescence before surgery and the potential role for antiviral prophylaxis, the researchers concluded. The study is published in the Journal of Cataract & Refractive Surgery.
  • In a cross-sectional study focused on clinical encounters of patients with microbial keratitis, Hamza Ashfaq, BS, and coresearchers found that almost 1 in 4 medications were mismatched between the progress note and the formal medication list in the electronic health record (EHR). Researchers focused on the medications of 53 patients with microbial keratitis at a tertiary care, referral academic medical center. Medication documentation was compared between the structured medication list taken from the EHR server and the medications written into the clinical progress note and transcribed by the study team. Among the 247 medications identified, 23.1% of prescribed medications differed between the progress notes and the formal EHR-based medication list. The reasons for the discrepancy included medications not prescribed via the EHR ordering system (43.9%), outside medications not reconciled in the internal EHR medication list (40.4%), and medications prescribed via the EHR ordering system and in the formal list but not described in the clinical note (15.8%). Nearly one-third of patients had at least one medication mismatch in their record. The findings suggest that EHR data should be checked for internal consistency before use in research, the authors concluded. The study is published in JAMA 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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