EyeWorld Weekly, June 4, 2021

EyeWorld Weekly, June 4, 2021

EyeWorld Weekly

June 4, 2021 • Volume 27, Number 22

Early termination of study evaluating Beovu

Novartis announced early termination of its Phase 3 MERLIN study, which was evaluating Beovu (brolucizumab) 6 mg vs. aflibercept 2 mg dosed every 4 weeks after a loading phase for patients with wet AMD with persistent fluid despite anti-VEGF therapy. According to the company’s press release, though Beovu met the study’s primary endpoint of noninferiority in change of BCVA from baseline and superiority for anatomical secondary endpoints, it was associated with higher rates of intraocular inflammation, including retinal vasculitis and retinal vascular occlusion compared to the aflibercept arm. The company stated that it terminated this study as well as its RAPTOR and RAVEN studies to preserve patient safety. According to the press release, a 2- to 3-month interval of Beovu following a loading phase is still an effective treatment option for some patients with wet AMD.

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NDA resubmitted to FDA for investigational macular edema treatment

Bausch + Lomb and Clearside Biomedical announced their resubmission of an NDA to the FDA for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension). XIPERE is an investigational treatment for macular edema associated with uveitis. According to the company’s press release, this is a Class 2 resubmission with an assigned PDUFA action date of Oct. 30, 2021.

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First peer-reviewed paper on visual recovery in a blind patient treated with optogenetic therapy

GenSight Biologics announced the publication of a paper in Nature Medicine that described a case report of partial vision recovery in a patient who was blind from late-stage retinitis pigmentosa who was treated with the company’s GS030 optogenetic therapy in a Phase 1/2 trial. According to the press release, this is the first peer-reviewed paper showing vision recovery with such a treatment in a patient blind from an inherited retinal disease. The company described GS030 as a treatment that combines gene therapy with a light-stimulating device. After treatment, the patient in the case report was able to perceive, locate, count, and touch objects, according to the press release.

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Study: New riboflavin formulation enhances transepithelial crosslinking

CXL Ophthalmics announced publication of a study involving Ribostat, its fixed-dose formulation of riboflavin and sodium iodide designed to be used in transepithelial crosslinking. The study, published in Clinical Ophthalmology, described how the iodide ions protect the concentration of riboflavin in the cornea during crosslinking with controlled experiments showing a statistically significant improvement in corneal stroma riboflavin concentrations during the procedure with this formulation. The company currently has an IND with the FDA for its EpiSmart crosslinking system, which includes Ribostat.

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Enrollment complete for blepharitis trial

Nicox announced completion of enrollment for its Phase 2b clinical trial of NCX 4251 as a treatment for blepharitis. More than 200 patients were enrolled and will receive either NCX 4251, an ophthalmic suspension of fluticasone propionate nanocrystals, or placebo. Topline results are expected in September 2021, according to the company.

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Companies partner to develop human-induced pluripotent stem cell-derived therapies for ocular diseases

Neurophth Biotechnology and Hopstem have partnered to create human-induced pluripotent stem cell-derived therapies for ocular diseases. According to Neurophth’s press release, the company has published proof-of-concept data for investigational gene therapies for retinal conditions, the most advanced of which is in development for ND4-mediated Leber hereditary optic neuropathy, which has an orphan drug designation from the FDA and an IND approved in China. The company has other therapies in the pipeline as well.

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ASCRS events

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Research highlights

  • A prospective, double-blind, randomized study evaluated the efficiency and tolerability of 0.5% cyclosporine A and fluorometholone for subepithelial infiltrates secondary to epidemic keratoconjunctivitis. The study included 72 eyes with subepithelial infiltrates, 38 of which were treated with topical fluorometholone and 34 of which were treated with topical cyclosporine. The research, published in the journal Cornea, found that resolution of subepithelial infiltrates was greater at 3 months in the fluorometholone group (3x greater). Resolution of subepithelial infiltrates was 70% in the fluorometholone group at 6 months and 47% in the cyclosporine group at this time point. Recurrence of subepithelial infiltrates was higher in the fluorometholone group than the cyclosporine group (16% vs. 9%, respectively). According to the study, fluorometholone was tolerated more at 3 months with less of a burning sensation upon instillation and less conjunctival injection; at 6 months, tolerance between the two groups was comparable. 
  • A study published in the British Journal of Ophthalmology described corneal epithelial mapping using OCT and a scoring system as a method to objectively diagnose dry eye disease. The study included 118 eyes of 59 patients with dry eye disease and 110 eyes of 55 control subjects. Corneal epithelial thickness was determined in seven zones using OCT. The researchers found significant epithelial thinning in the group with dry eye disease compared to control and identified superior intermediate epithelial thickness as the best marker for diagnosis of dry eye disease using OCT. The authors wrote that they used a multivariate approach and identified other significant covariables that they integrated into a multivariate model to improve sensitivity and specificity of this diagnostic method. 
  • A prospective, open-label, interventional, randomized, controlled study sought to determine patient preference and outcomes with intracanalicular dexamethasone vs. a standard drop regimen after bilateral refractive lens exchange surgery. According to the study authors, one eye in each patient received the intracanalicular dexamethasone while the other was treated with a steroid drop postop. Ninety percent of patients preferred the intracanalicular insert compared to 10% who preferred the steroid. In terms of treatment outcomes, there was no clinical or statistically significant difference between the two options. This research is published in the journal Clinical Ophthalmology.

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This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.

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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