Positive Phase 3 results from trial investigating ocular pain, inflammation treatment

Oculis Holding announced positive topline results from its Phase 3 trial that evaluated OCS-01 (dexamethasone), 15 mg/ml, for once-daily treatment of pain and inflammation after ocular surgery. According to the company’s press release, there was no inflammation in 57.2% of eyes treated with OCS-01 compared to 24.0% treated with vehicle at day 15. As for pain, 75.5% of eyes that received the investigational drop reported zero pain at day 4 compared to 52.0% on vehicle. The company reported that OCS-01 had a favorable safety profile with more treatment emergent adverse ocular events in the vehicle group. The drop has completed clinical trials for pain and inflammation management for both anterior and posterior segment conditions (cataract surgery and diabetic macular edema).

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Study evaluates use of sustained-release drug during Medicare pass-through program

Research published in JAMA Ophthalmology looked at the use and cost of sustained-release corticosteroids for cataract surgery during temporary Medicare pass-through reimbursement programs. The cross-sectional study of more than 4 million Medicare cataract surgeries between March 2019 and December 2021 found a low utilization rate of the sustained-release corticosteroid options (2.5%), despite the potential for patient compliance and convenience benefits, with a cost of around $500 per surgery. The authors wrote that “the high price needed to qualify for the Medicare pass-through program may have deterred the use of sustained-release corticosteroids for cataract surgery, suggesting, but not proving, that the current pass-through reimbursement rules may not be appropriate for sustained-release postoperative drugs.” An editorial published in the journal about this study explained that the pass-through program is intended to “[support] the availability of new drugs for beneficiaries during a defined initial period during which their use and impacts can be assessed.” The authors of the editorial wrote that the conclusions of the authors in this study gets to “an important policy observation” and puts forth a few reasons for the low utilization rate.

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FDA approves treatment for geographic atrophy

The FDA approved IZERVAY (avacincaptad pegol intravitreal solution) by Iveric Bio for treatment of geographic atrophy secondary to AMD. According to the company’s press release, IZERVAY is a complement C5 inhibitor that has shown in two Phase 3 clinical trials a statistically significant reduction in rate of geographic atrophy progression at 12 months. The company stated that the product will be available commercially in the U.S. within a few weeks.

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Dementia ‘much higher’ in patients with visual problems

Research published in JAMA Ophthalmology and in a press release from the University of Michigan further links problems with vision and cognitive issues, like dementia. According to the university’s press release, dementia prevalence was “much higher” in patients who presented with vision issues. The study included nearly 3,000 participants, among whom about 12% had dementia. About 22% of patients who couldn’t see well up close had dementia; 33% with moderate to severe distance vision, including blindness, had signs of dementia; 26% of patients who had contrast sensitivity issues had dementia; and 19% of those with mild distance vision impairment had dementia. The university’s press release stated that after adjusting for other differences, those with moderate to severe distance vision problems were 72% more likely to have dementia than those with no vision issues. In the paper, the authors concluded, “As most [visual impairment] is preventable, prioritizing vision health may be important for optimizing cognitive function.”

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ASCRS news and events

• ASCRS Podcast: Find the latest episode of Ophthalmology Quicksand Chronicles—Eureka Moments, featuring guest Steven Safran, MD.
• ASCRS Annual Meeting: The call for submissions for the 2024 ASCRS Annual Meeting is going on now through October 9. Find submission details here.
• ASCRS Satellite CME: Three clinical programs, a supplement to the main programming at the ASCRS Annual Meeting, are now available on demand. Find ASCRS Satellite CME offerings here.

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Research highlights

• A randomized, masked, controlled trial published in the Journal of Cataract & Refractive Surgery evaluated the astigmatism-reducing effect of toric IOLs when patients had low amounts (0.75–1.5 D) of corneal astigmatism. According to the paper, the first eye was randomized to receive either a toric or non-toric IOL and the second eye received the opposite. Fifty-eight eyes were included in the study. The postop median UDVA was 0.00 logMAR in eyes that had a toric IOL and 0.10 logMAR in non-toric eyes. Median CDVA was 0.00 in both groups. The authors reported that median residual astigmatism based on subjective and auto refraction was 0.25 D and 0.5 D, respectively, in the toric eyes and 0.5 D and 1 D, respectively, in the non-toric eyes. The authors concluded that toric IOLs “[appear] to be appropriate from a threshold value of approximately 0.75 D” preop, but they advocate for studies involving a larger patient population for confirmation.
• The visual outcomes of eyes that had a dropped nucleus during cataract surgery were reported in a retrospective chart review of prospectively reported cases from the Singapore National Eye Centre. According to the paper published in the journal Eye, dropped nucleus occurred in 0.17% of cataract surgery cases (n=292). Mean follow-up for these cases was 25.5 months, median 18.5 months. The authors reported a statistically significant difference in dropped nucleus rates between residents and faculty, 0.3% and 0.14%, respectively, but they noted that the rates of major subsequent complications were similar. Pars plana vitrectomy was performed in the majority of these cases, 87.2%; timing of vitrectomy (delayed or same day) did not affect final visual outcomes. Most patients (excluding those with other ocular pathology) at the final postop visit achieved a BCVA of 20/40 or better (85.2%). The investigators identified risk factors for having a poorer visual outcome; this included age (older than 70 years old), being left aphakic (no IOL implant), and other major complications.

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Product news

• Thea Pharma has acquired late-stage ophthalmic assets sepofarsen and ultevursen, both investigational RNA therapies, from ProQR Therapeutics.

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