EW Weekly, April 5, 2019

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April 5, 2019
Volume 24 , Number 13

FDA approves Avaclyr for herpetic keratitis

The FDA has approved the New Drug Application (NDA) for Avaclyr (acyclovir ophthalmic ointment, Fera Pharmaceuticals) for herpetic keratitis. The drug also was granted Orphan Drug exclusivity, which gives the company 7 years of marketing exclusivity. Avaclyr 3% is a herpes simplex virus nucleoside analog DNA polymerase inhibitor indicated to treat acute herpetic keratitis in patients with herpes simplex virus. The most common adverse reactions in patients were eye pain/stinging, punctate keratitis, and follicular conjunctivitis.

Lotemax SM launched in the U.S. for postop inflammation, pain

Lotemax SM (loteprednol etabonate ophthalmic gel 0.38%, Bausch + Lomb) has launched in the U.S. for postoperative inflammation and pain. The new gel formulation was designed with SubMicron technology for better penetration to key ocular tissues at a low preservative level, according to a company press release. The FDA recently approved LOTEMAX SM.

FDA accepts supplemental new drug submission for Dextenza for ocular inflammation

The FDA accepted the filing of a supplemental NDA for Dextenza to include the treatment of ocular inflammation after ophthalmic surgery, according to a company press release. The FDA has set a Prescription Drug User Fee Act target action date of Nov. 10, 2019, for its review of the supplemental NDA. Dextenza, an intracanalicular insert delivering dexamethasone, was approved by the FDA in November 2018 to treat postop surgical pain for up to 30 days.

Topline results announced for MAPLE study of abicipar pegol for nAMD

Topline safety results from the 28-week open-label study MAPLE with abicipar pegol were announced by Allergan and Molecular Partners. The trial enrolled 123 neovascular age-related macular degeneration (nAMD) patients and analyzed the safety of abicipar produced by a modified manufacturing process. Treatment naïve or prior anti-vascular endothelial growth factor-treated patients received three monthly 2 mg abicipar injections, followed by 2 mg injections every 8 weeks, for a total of five injections through week 28. The incidence of intraocular inflammation was 8.9% in the MAPLE study, which was lower than the rate observed in prior Phase 3 studies due to the manufacturing process improvements, according to the companies. The incidence of severe intraocular inflammation was 1.6%, with one case of iritis and one case of uveitis. The Biologics License Application for abicipar is expected to be filed by Allergan in the first half of this year.

Dosing of first patient occurs in Phase 2 study of elamipretide to treat dry AMD

The first patient has received elamipretide (Stealth BioTherapeutics) in the ReCLAIM-2 study, a Phase 2 study in patients with dry AMD with geographic atrophy, according to the manufacturer. ReCLAIM-2 is a double-masked, placebo-controlled, multicenter trial with approximately 180 subjects with non-central geographic atrophy in at least one eye. Subjects will be randomized 2 to 1 to receive elamipretide or placebo as a 40 mg once-daily injection for 48 weeks. The FDA granted Fast Track designation for elamipretide for patients with dry AMD with geographic atrophy.

Register now: FDA and ophthalmic community workshop on laser-based imaging

On April 8 from 8:00 a.m. to 4:30 p.m. EDT, join ASCRS, the FDA, and the ophthalmic community at the Tommy Douglas Conference Center in Silver Spring, Maryland, for a 1-day workshop that will focus on the latest trends and enhancements in ophthalmic laser-based imaging modalities, including: OCT and adaptive optics, regulatory and reimbursement considerations, and new topics of interest such as the Medical Device Development Tools program and the emerging role of artificial intelligence. Registration is required to attend. ASCRS members will receive a discounted rate of $295 (in-person) and $275 (webcast). To register for the public workshop, visit Forum on Laser-Based Imaging. If you have any questions or need help registering, contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org .

Register now for the April 10 "Phaco Challenging Cases and Complications" webinar

On Wednesday, April 10, at 9:30 p.m. EDT, ASCRS is hosting the "Phaco Challenging Cases and Complications" webinar, sponsored by the Young Eye Surgeons Committeel. This video-based webinar will cover complex cases that every cataract surgeon will encounter. Topics include: rock-hard cataracts, intraoperative floppy iris syndrome, zonular instability, and posterior capsule tears. Become a member of ASCRS today and receive all webinars complimentary as a member benefit . Please join ASCRS Young Eye Surgeons Committee members Sumit "Sam" Garg, MD, and Zaina Al-Mohtaseb, MD, with their expert panelists David Chang, MD, and Thomas Oetting, MD, for this engaging and valuable session.

Research briefs

  • After cataract surgery, patients with diabetic retinopathy were less likely to achieve a corrected distance visual acuity (CDVA) of 20/20. However, they gained as many lines of CDVA from phacoemulsification as patients without diabetes, reported Liyan Liu, MSc, and coresearchers who assessed the relationship between diabetic retinopathy severity, diabetes duration, insulin dependence, and preop hemoglobin A1C with visual outcome after phaco for cataract patients with type 2 diabetes. The retrospective case series included 65,370 patients, 28% of whom had type 2 diabetes without diabetic retinopathy, 5% of whom had nonproliferative diabetic retinopathy, and 1.2% of whom had proliferative diabetic retinopathy. Patients with diabetes but no diabetic retinopathy were as likely as those without diabetes to achieve a CDVA of 20/20. However, odds of a postop CDVA of 20/25 or worse grew with the severity of retinopathy, diabetes duration, and insulin dependence. However, it did not increase with preop hemoglobin A1C. The results showed no evidence that cataract surgery should be delayed in patients with diabetes who have an elevated hemoglobin A1C, the researchers concluded. The study is published in the Journal of Cataract & Refractive Surgery.
  • Incisional glaucoma surgery had a more pronounced effect on Goldmann applanation tonometry and contact lens sensor parameters than laser therapies and medications, according to Carlo A. Cutolo, MD, and coresearchers, who investigated the effect of different IOP-lowering interventions and a 24-hour ocular dimensional profile recorded by a contact lens sensor. Data from contact lens sensor done before and after IOP-lowering interventions were analyzed, along with three interventions: topical medications, laser trabeculoplasty, and incisional surgery. There were 182 eyes in the analysis: 60 with topical medications, 69 with laser treatment, and 53 with surgery. The mean Goldmann applanation tonometry IOP change was 3.6 mm Hg (P<0.001). More contact lens sensor parameters had a major change after surgery than in the other groups. Surgery was the most predictive of greatest percentage change in contact lens sensor signals. Eleven (9.5%) of the contact lens sensor parameters were significantly correlated with Goldmann applanation tonometry changes. A contact lens sensor can potentially detect changes in patterns resulting from IOP-lowering interventions beyond daytime Goldman applanation tonometry IOP, the researchers concluded. The study is published in the Journal of Glaucoma.
  • In a patient- and outcome-masked randomized controlled clinical trial, DMEK resulted in fewer posterior corneal higher-order aberrations (HOAs) compared with ultrathin DSAEK, reported Matthew J. Duggan, MD, and coresearchers. At 3, 6, and 12 months postop, the posterior corneal surface had significantly less coma and total HOA in DMEK compared to ultrathin DSAEK. Posterior trefoil, secondary astigmatism, and tetrafoil were lower in DMEK than in ultrathin DSAEK at 3, 6, and 12 months. There were no significant differences at any time in anterior surface HOA for DMEK and ultrathin DSAEK. The total posterior corneal HOA correlates moderately with 6- and 12-month postop visual acuity and may partially account for better visual acuity observed after DMEK, the researchers concluded. The study is published in Ophthalmology.
Product news
  • The Hood Glaucoma Report is now available with a software update within the SPECTRALIS OCT Glaucoma Module Premium Edition (Heidelberg Engineering).

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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