EW Weekly, March 6, 2020

FDA approves first intracameral, sustained-release bimatoprost implant
Allergan has announced FDA approval of Durysta, the first intracameral, sustained-release, biodegradable bimatoprost implant, for patients with open-angle glaucoma or ocular hypertension. A single-use, preloaded applicator is designed to deliver 10 mcg of the prostaglandin analog into the anterior chamber. In clinical trials it showed an approximately 30% reduction in IOP from baseline over 12 weeks, according to the company’s news release. David Nicholson, chief research and development officer for Allergan, said in the news release that this “provides a much-needed option for patients challenged with topical drops or needing alternative options." Mr. Nicholson also said that Allergan has five ongoing Phase 3 studies with Durysta that could support enhancement of the FDA label.

Study: SARS-CoV-2 may be present in coronavirus patients with conjunctivitis
SARS-CoV-2 may be found in the tears and conjunctival secretions in novel coronavirus pneumonia patients with conjunctivitis, reported Jianhua Xia, MM, and coresearchers, in a study published last week in the Journal of Medical Virology. The prospective interventional case series study included 30 confirmed novel coronavirus pneumonia patients (21 common type and 9 severe type) selected at the First Affiliated Hospital of Zhejiang University, Hangzhou, China, between January 26 and February 9. Tear and conjunctival secretions were collected two times so researchers could perform a reverse transcription polymerase chain reaction assay (RT-PCR). There was one patient with conjunctivitis; both of the patient’s tear and conjunctival secretions yielded positive RT-PCR results. The other patient samples (from patients who did not have conjunctivitis) were negative.

Novartis issues safety update for wet AMD drug Beovu
After members of the American Society of Retina Specialists (ASRS) were notified of 14 reports of vasculitis associated with the wet age-related macular degeneration drug Beovu (brolucizumab), drug maker Novartis issued a safety update. The company's prescribing information in the U.S. states a 4% intraocular inflammation rate and a 1% rate of retina artery occlusion, and Novartis reported it is conducting a "comprehensive review" of the reported cases of severe vision loss, inflammation, and potential retinal vasculitis. "We believe the incidence of these events remains consistent with or below the package insert," Novartis said in a press release. Physicians should let Novartis know if a patient's eye becomes red, sensitive to light, painful, or has a change in vision after Beovu administration. The 14 cases have occurred since the drug's U.S. FDA approval last October. Among the 14 were 11 cases of occlusive retinal vasculitis.

DREAM extension study: Halting of omega-3 supplementation did not lead to differing clinical results for dry eye
In an extension study of the Dry Eye Assessment and Management (DREAM) randomized clinical trial, patients who halted the use of omega-3 supplements for a year did not have significantly worse ocular surface outcomes compared with those who continued omega-3 supplementation, according to Munira Hussain and coresearchers. In the study, patients initially assigned to 3,000 mg of omega-3 fatty acids daily for a year in the primary trial were then randomized 1:1 to receive the active supplement or a placebo of refined olive oil for an additional year. Change in the Ocular Surface Disease Index (OSDI) was the primary outcome. Conjunctival staining, corneal staining, tear breakup time, Schirmer test results, and adverse events were among the secondary outcomes. In the 22 patients receiving omega-3 supplementation and the 21 receiving placebo supplements, there was a similar mean change in the OSDI score between months 12 and 24 (mean difference in change, –0.6 points). Researchers did not find any significant between-group differences for conjunctival staining (mean difference in change, –0.5 points), corneal staining (–0.3 points), tear breakup time (–0.8 s), and Schirmer test (0.6 mm). There were similar adverse event rates in both groups. The study is published in The Ocular Surface.

Second Phase 3 results with YUTIQ focus on reducing flares in chronic non-infectious uveitis
Topline 36-month follow-up data from the second Phase 3 trial of YUTIQ (fluocinolone acetonide intravitreal implant, EyePoint Pharmaceuticals) found the treatment had a long-term ability to lower uveitic flares, which was consistent with the first Phase 3 trial results. The second double-masked, randomized Phase 3 trial included 153 patients (101 eyes) at 15 clinical centers in India. Fifty-two eyes received sham injections. The recurrence rate at 36 months in YUTIQ-treated eyes was 46.5% versus 75% in the eyes receiving sham injections (P=0.001). The visual acuity gains or losses of three lines or more were similar between the treatment groups. A total of 8.9% of YUTIQ-treated eyes needed an adjunctive intraocular/periocular injection medication for uveitic inflammation compared with 51.9% of sham-treated eyes. Among the YUTIQ-treated eyes, 31.7% needed an adjunctive systemic steroid or immunosuppressant compared with 32.7% of the sham-treated eyes. YUTIQ was approved by the U.S. FDA in October 2018.

TOBRADEX ST launched by Eyevance
TOBRADEX ST (tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05%) has been launched in the U.S. by Eyevance Pharmaceuticals following the company’s product acquisition late last year. Eyevance acquired TOBRADEX ST and NATACYN (natamycin ophthalmic suspension) from Novartis.

Research briefs
  • In a systematic review and meta-analysis, autologous serum tears were found to be an effective treatment for dry eye disease, reported L. Wang and coresearchers. Their study included five databases that were searched for relevant randomized controlled trials comparing autologous serum eye drops versus artificial tears. The OSDI, Schirmer I test, tear breakup time, and fluorescein and rose bengal staining were used to evaluate efficacy. Seven randomized controlled trials were found with 267 subjects. Subject age in most studies was 50 years, with a treatment duration of about 8 weeks. The OSDI was lower after autologous serum treatment compared with artificial tears (mean difference, –10.75 points). No difference was found in the Schirmer I test after treatment between the two groups (mean difference, 1.68 points). Tear breakup time in the autologous serum group was longer than that in the artificial tear group (4.53 points). No statistically significant difference was found in the fluorescein staining scores between the two groups (–2.53 points). Rose bengal staining score in the autologous serum group was slightly lower than that in the artificial tear group (mean difference, –0.78). More randomized controlled trials with large samples and longer follow-up are needed to further target the role of autologous serum to manage dry eye disease, the researchers concluded. The study is published in Ophthalmic Research.
  • There were non-significant differences among nine formulas used for multifocal IOL implantation candidates, reported Joaquín Fernández, MD, and coresearchers. A method to make it easier to detect accuracy deficiencies of any IOL power calculation formula was used in the retrospective, observational case series and was tested among the nine formulas. The first stage of the study included 3,519 eyes from cataract surgery candidates. Frequency distributions were computed for axial length, anterior chamber depth, lens thickness, white-to-white, and mean corneal radius. Resulting data for each parameter were 5th , 25th, and 75th, and 95th percentile, allowing researchers to define a corresponding normality range. In the study’s second stage, a graphic representation method was tested for nine formulas in 70 eyes slated for cataract surgery with multifocal IOL implantation. The normality ranges were 22.84 to 24.42 mm for axial length, 2.86 to 3.39 mm for anterior chamber depth, 4.36 to 4.88 mm for lens thickness, 11.64 to 12.19 mm for white-to-white, and 7.52 to 7.87 mm for mean corneal radius. The graphical method showed less accuracy in ±0.50 D for anterior chamber depths from 2.46 to 2.85 mm for several formulas (P<0.05). The research appears in the Journal of Cataract & Refractive Surgery.

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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