EyeWorld Weekly, December 13, 2024

Topline results for non-steroidal immunomodulator for postop inflammation

VivaVision announced positive topline results from its Phase 2 U.S. trial investigating VVN461-CS-201 as a non-steroidal immunomodulator for the treatment of postop inflammation after cataract surgery. The study included 91 participants who had standard cataract surgery and were randomized to receive four doses daily of VVN461 1.0%, VVN461 0.5%, or vehicle. The company’s press release stated that VVN461 use showed statistical and clinical improvement compared to vehicle. At day 14 of use, 60% and 53.3% of participants in the 1% and 0.5% groups, respectively, achieved anterior cell chamber Grade 0, compared to 19.4% in the vehicle group. The press release also noted a clinically and statistically significant reduction in anterior chamber cell flare and patient-reported ocular pain.

Pilot study describes use of prosthetic device for treatment of dry eye

BostonSight announced publication of its pilot study that investigated the Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) with cyclosporine, 0.05%, for treatment of dry eye disease. The prospective clinical trial, published in the journal Clinical Ophthalmology, is the first, according to the company’s press release, to “[utilize] a pharmaceutical in this manner.” According to the paper, the study enrolled 14 PROSE wearers, nine of whom (18 eyes) completed the study. The participants put one drop of preservative-free cyclosporine, 0.05%, in the PROSE reservoir and filled the rest with preservative-free saline. They then wore the device for 6 hours, repeated the drug/saline-loading protocol, and wore PROSE for an additional 4 hours each day. Sign and symptom data were collected at baseline, 1 week, and 1 month. After 1 month, OSDI scores improved to 3.83±6.87 from baseline (p=0.07); there was no statistically significant change in BCVA, according to the paper. Though not compared to a placebo, the authors wrote that there “was statistically significant (p<0.05) improvement in mean per subject and mean per eye corneal fluorescein staining, conjunctival lissamine staining, and conjunctival hyperemia by slit lamp examination at one-month follow-up.”

First patient dosed in Phase 3 trial investigating wet AMD treatment

EyePoint Pharmaceuticals announced that the first patient has been dosed in its second, global Phase 3 clinical trial for DURAVYU (EYP-1901) for treatment of wet AMD. The investigational treatment is of vorolanib delivered via the bioerodible Durasert E sustained drug delivery implant. EyePoint is conducting two Phase 3 trials, comparing 2.7 mg DURAVYU to an aflibercept control; both trials will also evaluate re-dosing, according to the company’s press release. The company expects topline data for this pivotal program in 2026.

Acquisition and partnership news

ASCRS news and events

  • 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California.
  • ASCRS Live!: This educational dinner series, which made its way to several cities across the U.S. in 2024, has wrapped up for the year. Stay tuned for information about 2025 in-person events.
  • ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.

Research highlights

  • A retrospective case-control study published in the Journal of Cataract & Refractive Surgery sought to differentiate between normal corneas and those with forme fruste keratoconus using SS-OCT topography CASIA2 (Tomey) and machine learning algorithms. The study included three groups: 108 eyes with keratoconus, 88 eyes with forme fruste keratoconus, and 162 normal corneas. According to the paper, “machine learning models (random forest [RF], logistic regression [LR]) were used to develop a multiclass classifier for automated early KC detection.” These were then trained with a training database and tested with a test database and compared to the Ectasia Screening Index. The investigators found that both models detected forme fruste keratoconus “with an area under the curve of 0.99 and 0.98,” for RF and LR, respectively. They had sensitivities of 84% and 100%, respectively, which the authors noted were better than the Ectasia Screening Index sensitivity for forme fruste keratoconus diagnosis of 28%. With this research, the authors identified “discriminating topographic parameters to be considered in refractive surgery screening on SS-OCT CASIA2” and developed “an algorithm capable of classifying normal eyes vs. forme fruste keratoconus cases.
  • The 1-year safety and efficacy of “bio-interventional cyclodialysis and scleral reinforcement” via an ab interno approach for patients with open angle glaucoma having cataract surgery was investigated in a prospective, consecutive case series published in the journal Clinical Ophthalmology. The cyclodialysis, according to the study, was followed by visco-cycloplasty and reinforcement with a modified allograft scaffold to “maintain patency of the cyclodialysis reservoir and increase uveoscleral outflow,” according to the authors. The study included 117 eyes, which had a mean baseline BCVA of 20/40 and a mean medicated IOP of 20.2± 6.0 mm Hg on 1.4±1.3 IOP-lowering medications. After the procedure, at 12 months, there was a 27.1% reduction in medicated IOP, and eyes with a medicated baseline IOP of more than 21 mm Hg showed a “39.7% paired IOP reduction at 12 months with a concurrent reduction in the mean number of IOP-lowering medications to 0.8±0.9, which were statistically significant (p<0.01).” Among the whole group, 81.9% of eyes achieved a medicated IOP of 18 mm Hg or less with no increase in medications 12 months postop. In 3.2% of cases, a secondary glaucoma surgery was needed to achieve target IOP, according to the paper.

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

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: Sumit “Sam” Garg, MD, Chief Medical Editor, Mitchell Weikert, MD, Cataract Editor, Karolinne Rocha, MD, PhD, Refractive Editor, Julie Schallhorn, MD, Cornea Editor, Manjool Shah, MD, Glaucoma Editor

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