EW Weekly, September 27, 2019

Fast-track designation given to ADX-2191 for prevention of proliferative vitreoretinopathy
The FDA has granted a fast-track designation to ADX-2191 (Aldeyra Therapeutics) for the prevention of proliferative vitreoretinopathy. The company plans to begin its adaptive Phase 3 GUARD trial of ADX-2191 in the fourth quarter of this year. The trial will compare recurrence rates of proliferative vitreoretinopathy-related retinal detachment across patients treated with ADX-2191 or standard of care after surgical repair of retinal detachment.

Study: Ocular drug prices in the U.S. differ widely
There is significant variation in prices for ophthalmic medications in the U.S., particularly topical agents, Dan Gong, MD, and coresearchers reported. Their cross-sectional, observational study focused on U.S. and international drug pricing for commonly prescribed intravitreal and topical ophthalmic medications. Researchers obtained the 2017 third-quarter wholesale average price, drug acquisition cost, or consumer pricing through U.S. government health insurance plans, commercial drug plans, and online pricing without insurance through a large U.S. warehouse retailer. Researchers also studied international drug pricing in Italy, Spain, Turkey, Canada, and Japan. In the U.S., aflibercept (Eylea, Regeneron Pharmaceuticals) and ranibizumab (Lucentis, Genentech) were priced similarly and were more costly than dexamethasone implants. Pricing for the same two drugs through government health insurance plans abroad was less costly, by as much as 84.3%, compared to the U.S. Pricing in the U.S. for topical medications varied significantly for both branded and nonbranded medications. The study is published in JAMA Ophthalmology.

Phase 2 trial results released for geographic atrophy treatment APL-2
A 29% reduction in the growth of geographic lesion areas occurred at 12 months in the monthly treatment group from the Phase 2 FILLY study, which focused on intravitreal APL-2 (pegcetacoplan, Apellis Pharmaceuticals) secondary to AMD, according to a company press release. The FILLY study was a multicenter, randomized, single-masked, sham-controlled trial assessing APL-2 in 246 patients at more than 40 sites in the U.S., Australia, and New Zealand. APL-2 was given as an intravitreal injection monthly or every other month for 12 months, followed by a 6-month monitoring period. Change in geographic atrophy lesion area from baseline to month 12 compared to sham was the primary efficacy endpoint. A 20% reduction was observed in the bimonthly treatment group. The effect was more pronounced in the last 6 months of treatment with observed reductions of 45% and 33% for APL-2 monthly and every other month, respectively, compared to sham. There was a higher incidence of exudation in APL-2 treated eyes (20.9% and 8.9% in the monthly and bimonthly groups, respectively) compared with sham-treated eyes, which was manageable with standard-of-care treatment. APL-2 currently has a fast-track designation for geographic atrophy treatment. Apellis is currently enrolling for two Phase 3 studies to assess the efficacy and safety of multiple intravitreal injections of APL-2 in patients with geographic atrophy secondary to AMD.

EMA's CHMP recommends approval for Rhokiinsa
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of the marketing authorization application for Rhokiinsa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals), according to a company press release. The indication for Rhokiinsa is lowering elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension. Rhokiinsa is marketed as Rhopressa in the U.S. A final decision will come in 2 months and will be applicable to all European Union member states plus Iceland, Norway, and Liechtenstein, according to the press release.

Company receives European grant for molecule to help treat ocular inflammation
Tarsius Pharma has received a HORIZON 2020 Grant from the European Commission worth approximately $2.6 million to help develop its bio-inspired technology for ocular inflammatory diseases from within the immune system, according to a company press release. Tarsius uses a patented, proprietary molecule that was developed to "re-engineer" the immune system, according to the company. Its platform may potentially treat an array of autoimmune and inflammatory ocular diseases.

Submit your nomination for the inaugural ASCRS Educator Award
The new ASCRS Educator Award recognizes an ASCRS member who has made education an enduring career priority. Nominees must: have demonstrated passion and commitment to education, leadership, and selflessness in the pursuit of expanding knowledge in the interest of improving patient outcomes; be an ophthalmologist focused on anterior segment surgery; have at least 5 years in practice; and be a current ASCRS member. Nominations are due by November 29. Find more information at ascrs.org/educatoraward.

Research briefs
  • In a cohort study, the rate of filled opioid prescriptions increased for all types of incisional ocular surgery over time, according to Anton Kolomeyer, MD, PhD, and coresearchers. The study included patients with incisional ocular surgeries within a large national U.S. insurer's administrative medical claims database from 2000-2016. The primary analysis focused on the rate of filled opioid prescriptions for each ophthalmic subspecialty surgery over time. Among more than 2.4 million incisional ocular surgeries included, 1.90% were associated with an opioid prescription. The rate of filled opioid prescriptions varied, with the lowest rate in the 2000-2001 cohort year and the highest in 2014. A trend toward filling more prescriptions was seen in the later years. With the ongoing national opioid crisis, understanding use patterns could help reverse the epidemic, the researchers concluded. The research appears in JAMA Ophthalmology.
  • In a cross-sectional study focused on classifying subtypes of meibomian gland dysfunction (MGD) and evaluating the dependency of dry eye signs, symptoms, and parameters of MGD subtypes, Jiaxin Xiao and coresearchers found that patients with low-delivery MGD had worse dry eye parameters and ocular symptoms than those with high meibum delivery. The study included the right eyes of 447 patients with MGD of various subtypes and 20 healthy volunteers who were divided into one of four subtypes: high meibum delivery (hypersecretory and non-obvious MGD) and low meibum delivery (hyposecretory and obstructive MGD). In addition to meibum expression, meibum quality, and meibomian gland loss on images, clinical tests included tear film breakup time (TBUT), ocular staining, osmolarity, and Schirmer I and additional testing. There were 78 eyes with hypersecretory MGD, 49 eyes with nonobvious MGD, 66 eyes with hyposecretory MGD, and 254 eyes with obstructive MGD. In the low delivery groups, increased tear film osmolarity and lower TBUT were found. Ocular symptoms and staining were worse in the low delivery MGD groups than the high delivery groups. The findings show the pivotal role of meibum secretion on ocular surface health and indicate that non-obvious MGD cannot be diagnosed via traditional dry eye tests, the researchers concluded. The study is published in the American Journal of Ophthalmology.
  • When comparing accelerated collagen crosslinking (CXL) alone to CXL with simultaneous intrastromal corneal ring segments (CXL-ICR) and CXL with simultaneous topography-guided photorefractive keratectomy (CXL-TG-PRK), JNeera Singal, MD, and coresearchers found that CXL-ICR may be more effective for eyes with more irregular astigmatism and worse corrected distance visual acuity (CDVA). Additionally, CXL-TG-PRK may be best for eyes that require improvements in irregular astigmatism but that still have good CDVA. Their prospective, nonrandomized, interventional study included 452 eyes from 375 subjects with progressive keratoconus, pellucid marginal degeneration, or LASIK-induced ectasia who underwent accelerated CXL (n = 204), CXL-ICR (n = 126), or CXL-TG-PRK (n = 122). Visual and topographic outcomes were evaluated 1 year postop. The change in logMAR uncorrected distance visual acuity was significant with CXL-ICR and CXL-TG-PRK but not CXL alone. Improvement in CDVA was greater with CXL-ICR than CXL alone and CXL-TG-PRK. The study appears in the Journal of Cataract & Refractive Surgery.
Product News
  • Preloaded DMEK tissue is now available in the Melles DORC tube (Eversight).

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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