EW Weekly, October 5, 2018

October 5, 2018
Volume 24 , Number 37

Phase 2b trial results announced for ocular reproxalap for dry eye

Phase 2b clinical trial results for topical ocular reproxalap (Aldeyra Therapeutics, Lexington, Massachusetts) in patients with dry eye disease found that the agent could be a treatment option relevant to existing therapies, according to a company press release. The randomized, vehicle-controlled, multicenter, double-masked trial investigated 0.1% and 0.25% concentrations of reproxalap compared with the vehicle in 300 patients for 12 weeks. The trial focused on safety and efficacy of reproxalap to treat signs and symptoms of dry eye disease to select a drug concentration, confirm endpoint selection, and determine sample size for a pivotal Phase 3 clinical program. Patients treated with the 0.25% concentration had statistically significant and clinically relevant reductions in the Four-Symptom Ocular Dryness Score (P<0.05) and the Overall Ocular Discomfort Symptom Score (P<0.05). Symptoms improved greater than the vehicle across all measures. Both concentrations of reproxalap showed activity relative to the vehicle, and a clear dose response was observed. The company plans to initiate a Phase 3 program for the agent next year.

Omeros announces reinstatement of pass-through status for Omidria

Reinstatement of separate payment by the Centers for Medicare and Medicaid Services under the pass-through program for Omidria (phenylephrine and ketorolac intraocular solution, Omeros Corporation, Seattle) 1%/0.3% went into effect on October 1, according to a company press release. Omidria and a small number of other drugs used during procedures with Medicare Part B fee-for-service patients received a 2-year extension of pass-through reimbursement status as a result of a bipartisan congressional response to nationwide concerns regarding limited access for Medicare beneficiaries to these drugs. The latter is due to inadequate reimbursement when payments for the drugs are packaged into their respective procedural fees, the company explained. Omeros continues to pursue permanent separate payment for Omidria.

Worldwide rights to Nexagon acquired by Eyevance

Worldwide rights to Nexagon were acquired this week by Eyevance Pharmaceuticals (Fort Worth, Texas). Nexagon is a 30-base antisense oligomer in development for persistent corneal epithelial defect nonresponsive to standard of care. The acquisition of Nexagon was made from the company OcuNexus (San Diego). Nexagon is a first-in-class, unmodified antisense oligodeoxynucleotide that inhibits a cell membrane hemichannel forming protein, connexin43, according to an Eyevance press release.

Submit your ASCRS Film Festival entries today

Submissions are now being accepted for the 2019 ASCRS Film Festival. The deadline for submissions is Wednesday, October 17.
Established in 1982, the Film Festival Awards honor the best filmmakers in ophthalmology. Each year, members are invited to submit film entries, and a panel of nine judges rate the submitted films on applicability/educational value, originality, scientific content/validity, clarity, cinematic quality, and artistic effects. The full list of film categories is available on the submissions website.
A grand prize winner, a runner-up, and a winner from each category will be announced during the 37th Annual Film Festival Awards at the 2019 ASCRS*ASOA Annual Meeting, May 3-7 in San Diego. Download the full 2019 ASCRS/ASOA Submission Guide for more information.

Research briefs

  • A higher adherence to a Mediterranean diet was associated with a 41% lower risk of incident advanced age-related macular degeneration (AMD), according to a prospective cohort study led by Bénédicte M.J. Merle, PhD, and coresearchers. The study combined data from the Rotterdam Study I (RS-I) and the Alienor study populations. A total of 4,446 participants age 55 or older from the RS-1 student and 550 French adults age 73 or older from the Alienor Study with complete ophthalmologic and dietary data were included in the present study. Exams were performed every 5 years over a 21-year study period in the RS-I and every 2 years over a 4-year period in the Alienor Study. A nine-component score was used to evaluate adherence to a Mediterranean diet based on intake of vegetables, fruits, legumes, cereals, fish, meat, dairy products, alcohol, and monounsaturated-to-saturated fatty acids. There were 155 included participants who demonstrated incident advanced AMD. Participants with a high Mediterranean diet score had a significantly lower risk for incident advanced AMD compared with participants with a low score. The study is published in Ophthalmology.
  • A retrospective analysis of intraoperative aberrometry for IOL power determination found that among approximately 32,000 eyes, those with calculations that incorporated intraoperative aberrometry outperformed preop calculations, according to Robert Cionni, MD, and coresearchers. The difference was more evident in eyes in which the preop planned IOL power was different than the power of the IOL implanted. In their analysis of a database of eyes from around the U.S., the primary endpoints included the difference between mean and median absolute prediction error with intraoperative aberrometry versus preop calculation; the percentage of cases was compared when the prediction error was 0.5 D or less. The intraop aberrometry absolute prediction error was lower than the preop calculation (0.30 D versus 0.36; P<.0001). Aberrometry absolute median prediction error was lower than the preop calculation (0.24 D versus 0.29 D; P< .0001). There was a larger percentage of eyes with an aberrometry absolute prediction error of 0.5 D or less than eyes with a preop absolute prediction error of 0.5 D or less. The study appears in the Journal of Cataract & Refractive Surgery.
  • A study from Imran Mohammed and coresearchers has helped identify why Descemet's membrane endothelial keratoplasty and pre-Descemet's endothelial keratoplasty tissues always scroll with the endothelial cells on the outside. The experimental study measured elastin content in Descemet's membrane (DM), pre-Descemet's layer, central and peripheral stroma, sclera, and trabecular meshwork using a Fastin elastin assay kit. The distribution of elastin in DM, pre-Descemet's layer, and anterior lens capsule were examined by immunohistology. The pre-Descemet's layer showed the highest elastin content among the tissues study. The elastin localized as a distinct anterior band in the DM and was uniformly distributed in the pre-Descemet's layer, demarcating the latter from the corneal stroma, according to the authors. The use of enzymatic treatment of DM with elastase reversed scrolling and corresponded with degradation or disappearance of elastin. High elastin content and uniform distributing in the pre-Descemet's layer suggest a structural difference from the posterior stroma, the researchers concluded. The study is published in the American Journal of Ophthalmology.
  • Hispanic/Latino race and lack of application of steroid ointments were risk factors for a greater chance of a higher IOP after pterygium surgery, according to Kevin Wu and coresearchers. Their retrospective cohort study focused on pre- and postop IOP measures (day 1, week 1, months 1 and 3, and when clinically necessary). Age, sex, race, baseline IOP, cup-to-disc ratio, glaucoma history, and frequency of postop steroid drop use were compared. Patients with a postop IOP measurement of 22 mm Hg or higher or with an IOP increase of 10 mm Hg or higher compared with the preop measurement was labeled the ocular hypertension group. Forty-eight of 212 eyes (22.64%) had postop IOP elevation within 3 months of operation. Although no significant differences were found between the various factors analyzed, Hispanic/Latino race and lack of steroid application ointment were significant risk factors for the development of ocular hypertension. The study is published in Clinical Ophthalmology.

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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