EW Weekly, June 28, 2019

AbbVie to acquire Allergan
AbbVie will acquire Allergan in an approximately $63 billion deal, according to a joint announcement from the companies. The two companies have a 2019 annual combined revenue of about $48 billion and a presence in more than 175 countries.

First patient enrolled in Phase 2b clinical trial of Oxervate for dry eye
The first patient has been enrolled in NGF0118, a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of the recombinant human nerve growth factor Oxervate (Dompé) for moderate to severe dry eye disease, according to a company press release. Oxervate was approved previously by the U.S. FDA to treat neurotrophic keratitis. The current study will include an estimated 300 eligible adult patients among 11 U.S.-based sites. The study will analyze the safety and efficacy of recombinant human nerve growth factor eye solution compared with vehicle. There will be 4 weeks of active treatment, followed by 12 weeks of observation. The study's primary endpoint will be change from baseline in ocular surface tear wetting as measured with a Schirmer I test. Secondary endpoints will be signs and symptoms of dry eye, including ocular surface staining. As part of a separate study, Dompé; will collect various biomarker information from patients as part of a plan to develop tailored treatments.

Aldeyra program for noninfectious anterior uveitis halted
Based on results from the SOLACE trial for noninfectious anterior uveitis, Aldeyra Therapeutics has decided to stop its noninfectious anterior uveitis program. In the SOLACE trial, statistical significance was not achieved with the agent reproxalap for primary or secondary endpoints due to high rates of disease resolution in vehicle-treated patients. However, the activity of reproxalap was consistently greater than that of vehicle, the company announced. Company leaders plan to continue prioritizing the advancement of reproxalap in ocular programs for dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy.

Glaukos to acquire DOSE Medical Corporation
Glaukos has entered into a definitive agreement and plan of merger to acquire DOSE Medical Corporation in a $2.5 million cash deal. DOSE Medical will become a wholly owned subsidiary of Glaukos when the agreement is finalized. The transaction is slated to close this quarter. The acquisition expands Glaukos into the retina space, as DOSE Medical develops multiple, microinvasive, sustained-release drug delivery platforms for retinal diseases including age-related macular degeneration and diabetic macular edema.

Positive recommendation given for ILUVIEN in the U.K. for non-infectious posterior uveitis
The U.K.'s National Institute for Health and Care Excellence (NICE) has recommended funding for ILUVIEN 190 micrograms intravitreal implant (Alimera Sciences) to prevent the relapse of noninfectious uveitis affecting the posterior segment, according to an Alimera press release. In the U.K., a recommendation from NICE for funding signifies that the U.K. National Health Service will pay for prescriptions of ILUVIEN to treat noninfectious posterior uveitis. The agent is already approved in the U.K. for diabetic macular edema.

Research briefs
  • In a study comparing intraoperative aberrometry results to preop biometry-based methods for IOL power in short eyes, there was no significant difference between the two, reported Shruti Sudhakar, MD, and coresearchers. The retrospective consecutive case series included eyes with an axial length shorter than 22.1 mm that had cataract extraction and IOL implantation. Predicted residual refractive error was calculated preoperatively with Hoffer Q, Holladay 2, Haigis, Barrett Universal II, and Hill-RBF formulas and intraoperatively using intraop aberrometry. For each aforementioned method, the postop spherical equivalent was compared with the predicted spherical equivalent. A total of 51 eyes from 38 patients were included. The mean numerical errors associated with Hoffer Q, Holladay 2, Haigis, Barrett Universal II, Hill-RBF and intraop aberrometry were –0.08, –0.14, +0.26, +0.11, +0.07, and +0.00, respectively (P<.001). The proportion of eyes within ±0.5 D of the predicted spherical equivalent were 49.0%, 43.1%, 52.9%, 52.9%, 60.8%, and 58.8%, respectively. Prediction outcomes from intraop aberrometry were better statistically than Haigis but not with other formulas. The study is published in the Journal of Cataract & Refractive Surgery.
  • Omidenepag isopropyl showed stable IOP-lowering effects and was well tolerated in a Phase 2 study focused on the agent's safety and efficacy, according to Makoto Aihara, MD. The researchers reported on results from three randomized, multicenter studies focused on the selective EP2 agonist. Patients in the studies were randomized to 1 of 7 omidenepag isopropyl concentrations ranging from 0.0003% to 0.003%, latanoprost (0.005%), or placebo and one drop daily for 28 days (studies 1 and 3) or 90 days (study 2). The primary endpoints were the observed mean diurnal IOP and the IOP at each time point on the final visit as well as change from baseline in mean diurnal IOP at week 4 (study 3). Intraocular pressure-lowering effects were observed dose dependently; at 0.002% and 0.0025%, there were clinically relevant mean diurnal reductions in IOP from baseline that were similar to latanoprost and superior to placebo. A dosing of 0.002% was identified as the optimal dose for a Phase 3 investigation. The research is published in the Journal of Glaucoma.
  • There are fewer posterior corneal higher-order aberrations (HOAs) with Descemet’s membrane endothelial keratoplasty (DMEK) compared with ultrathin Descemet’s stripping automated endothelial keratoplasty (DSAEK), according to Matthew Duggan, MD, and coresearchers. In their patient- and outcome-masked randomized controlled clinical trial, patients with damaged or diseased endothelium from Fuchs’ endothelial dystrophy or pseudophakic bullous keratopathy were included. The corneal anterior and posterior surface HOA were measured with Scheimpflug imaging before surgery and at 3, 6, and 12 months postop. The posterior corneal surface had significantly less coma and total HOA at the postop time points in DMEK compared with ultrathin DSAEK. Posterior trefoil, secondary astigmatism, and tetrafoil were lower in DMEK than in ultrathin DSAEK post. No significant differences were seen in anterior surface HOAs at any post-surgical time. Total posterior HOA was increased in ultrasound DSAEK postop compared with baseline; in DMEK it was decreased at 6 and 12 months (4.0- or 6.0-mm OZ, or both). Total posterior corneal HOA correlates with 6- and 12-month postop visual acuity and may account for better visual acuity after DMEK, the researchers concluded. The study is published in Ophthalmology.
  • In the first year after lensectomy in children younger than 13 years, amblyopia was frequently observed, reported the Writing Committee for the Pediatric Eye Disease Investigator Group. Their prospective, observational study included 880 children who were seen at 61 pediatric eyecare practices and had follow-up within 15 months after surgery. All patients had lensectomy with or without implantation of an IOL. Lens surgery was bilateral in 41.1% of patients; the mean age at the annual follow-up was 4.9 years. Amblyopia was identified in 51% of children. A new glaucoma or suspected glaucoma diagnosis was made in 5.9% of eyes that did not have glaucoma before lensectomy. In 17% of eyes, additional intraocular surgery—most commonly vitrectomy or membranectomy—were needed to clear the visual axis. In children age 2 or older, visual acuity was typically less than normal for age and was worse with unilateral cataract. The study appears 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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