FDA approves drop for mydriasis reversal

Ocuphire and Viatris announced FDA approval of RYZUMVI (phentolamine ophthalmic solution) for the treatment of pharmacologically induced mydriasis. The companies’ press release stated that this drop is intended to reverse dilation produced by adrenergic agonists, such as phenylephrine, and parasympatholytic agents, such as tropicamide. The companies explained that pharmacologic agents, needed for dilated eye exams to detect vision-threatening diseases, can induce photophobia and blurred vision, which impacts daily activities until the pupil returns to normal function. The clinical trial program for RYZUMVI included more than 600 participants, including some pediatric patients. In a Phase 3 trial, a greater percentage of participants who received the study drop saw a pupil diameter that returned to within 0.2 mm of baseline or less at all timepoints from 60 minutes post-instillation through 24 hours. Commercial availability of RYZUMVI is expected within the first half of 2024.

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Inventors of OCT honored with ‘American Nobel Prize’

James Fujimoto, PhD, David Huang, MD, PhD, and Eric Swanson, MD, MS, were honored with the 2023 Lasker-DeBakey Clinical Medical Research Award for their invention of optical coherence tomography (OCT). According to MIT’s news release about the award, the Lasker Awards are “considered one of the most prestigious prizes for biomedical research,” and other sources have described them as being the “American Nobel Prize.”

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Preservative-free latanoprost begins U.S. launch

Thea Pharma announced the U.S. launch of IYUZEH (latanoprost ophthalmic solution). According to the company’s press release, IYUZEH is the “first and only preservative-free latanoprost” approved in the U.S. for patients with primary open angle glaucoma and ocular hypertension.

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Enrollment complete in myopia treatment trial

Dopavision has completed enrollment for its MyopiaX-1 trial, which is evaluating the use of a technology-based treatment for stemming myopia progression. According to the company’s press release, MyopiaX is a non-invasive, non-pharmaceutical medical device. The current trial is randomized and controlled to evaluate safety, tolerability, and clinical outcomes over a 12-month period. It enrolled more than 100 participants with progressive myopia between 6–14 years old.

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ASCRS news and events

• 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 Live Webinar: “Complex Presbyopia IOLs,” a live educational event, will take place Tuesday, October 24 at 9:00 p.m. ET. Register now for this webinar.

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Research highlights

• A cross-sectional comparative study published in JAMA Ophthalmology assessed the quality of ophthalmic scientific abstracts and the legitimacy of references generated by artificial intelligence (AI) chatbots. More specifically, the authors used two versions of an AI chatbot (an early version and an updated version) to generate abstracts and 10 references for clinical research questions in seven ophthalmic subspecialties. These abstracts were then graded by two human authors using modified DISCERN criteria and other performance evaluation scores. According to the paper, the DISCERN scores for the abstracts were 35.9 and 38.1 out of a max score of 50 for the early and updated chatbot versions, respectively. This, the authors concluded, showed that the chatbot could generate “average quality” abstracts. There was, however, a “high hallucination rate” when it came to generating fake references (unverifiable references), and the authors urged “caution … when using these AI resources for health education or academic purposes.”
• The long-term outcomes of toric implantable collamer lenses (ICLs) was the subject of a retrospective observational study published in the Journal of Cataract & Refractive Surgery. The study included patients (77 patients, 133 eyes) who had toric ICL surgery between 2005–2009 and who were evaluated again 8–10 years postop. According to the authors, the mean uncorrected and corrected visual acuities at the final visit were −0.01±0.2 and −0.17±0.05, respectively. Manifest astigmatism was −0.45±0.43 D, and mean change in corneal astigmatism from 1 year postop to the final visit was 0.40±0.26 D. The authors noted that in the 38 eyes with a 0.5 D or more change in corneal astigmatism over the long-term follow-up period, most (78.9%) were against the rule. Mean manifest astigmatism change from the 1-year postop visit to the final long-term follow-up visit was 0.43±0.52 D. Sixty eyes experienced a change in manifest astigmatism of 0.5 D or more, and 41.7% of these changed to against-the-rule astigmatism, followed by 30% oblique astigmatism, and 28.3% with-the-rule astigmatism. In the 8- to 10-year follow-up period, 6% of cases developed anterior subcapsular cataracts, and 3% had ICL removal followed by cataract surgery. The authors reported no vision-threatening complications.

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Product news

• Apellis received a permanent J-code (J2781) for SYFOVRE (pegcetacoplan injection), effective October 1.

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