First FDA-approved treatment for geographic atrophy

The FDA approved the first treatment for geographic atrophy secondary to AMD. The approval of SYFOVRE (pegcetacoplan injection) from Apellis Pharmaceuticals is, according to the company’s press release, “the most important event in retinal ophthalmology in more than a decade.” SYFOVRE is indicated for treatment of geographic atrophy for patients with or without subfoveal involvement; there is dosing flexibility (every 25–60 days), according to the company. The approval is based on two Phase 3 studies, which showed increasing treatment effects over time.

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FDA accepts NDA for presbyopia drop

The FDA accepted Orasis Pharmaceutical’s NDA for its drop designed to temporarily correct the effects of presbyopia. CSF-1, according to the company, is a preservative-free, low-dose pilocarpine hydrochloride drop. The company’s two Phase 3 clinical trials that were the basis for its NDA submission included more than 600 patients; both trials met their primary and secondary endpoints, which was a statistically significant 3-line or more gain in DCNVA with no loss of 1 or more lines of distance visual acuity on day 8. The PDUFA goal date for CSF-1 is set for October 22.

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NDA for geographic atrophy drug accepted with priority review

The FDA accepted IVERIC bio’s NDA for avacincaptad pegol (ACP), which the company described as an investigational complement C5 inhibitor for the treatment of geographic atrophy secondary to AMD. According to the company’s press release, ACP is designed to decrease activity of the complement system that causes retinal cell degeneration. The NDA is based on two Phase 3 clinical trials that showed the investigational treatment could achieve its prespecified primary endpoints at 12 months, with efficacy rates of up to 35% observed. The PDUFA goal date is set for August 19.

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Study: 5-year visual field data with MIGS device

Post hoc analysis of data published in the American Journal of Ophthalmology compared visual field progression of glaucoma patients who received cataract surgery alone or cataract surgery with the Hydrus Microstent (Alcon). The analysis included 352 eyes that received cataract surgery plus Hydrus and 165 that received cataract surgery alone. Visual field testing was obtained at 6 months then every year postop for 5 years. According to the paper, the rate of progression was –0.26 dB/year for the group that received Hydrus and –0.49 dB/year for the cataract surgery alone group, a significant difference. The authors reported that there was an increased probability of the visual field worsening by 5.5 dB, which they noted “[indicates] a greater proportion of fast progressors in the [cataract surgery alone] arm.” The authors concluded that cataract surgery combined with Hydrus Microstent implantation “has a significant effect on [visual field] preservation in glaucoma patients compared to [cataract surgery] alone.”

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the ASCRS Annual Meeting, May 5–8, 2023, in San Diego, California, is ongoing. “Make Waves” in education, innovation, and networking specifically focused on anterior segment surgery.
• ASCRS Annual Meeting Preview Program: The ASCRS Annual Meeting Preview Program is available online with more details about Annual Meeting schedules and programming.
• Eyecelerator: Registration is open for Eyecelerator @ ASCRS 2023. The innovation conference from ASCRS and the American Academy of Ophthalmology will be held on May 4 in San Diego, California. Join investors, industry leaders, and ophthalmologists at this showcase of companies, technology, and other exciting innovation topics in ophthalmology. Sponsorship opportunities and opportunities to present at the Eyecelerator Marketplace are available now. More detailed program information will be coming soon.

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Research highlights

• A comparative prospective clinical study published in the Journal of Cataract & Refractive Surgery reviewed the effect of ptosis surgery on IOL power measurements and other ocular biometric parameters. Patients with ptosis were divided into three groups based on severity of their droopy eyelid: Group 1 was more than 4 mm (n=19), Group 2 was 3–4 mm (n=22), and Group 3 was 1–2 mm (n=16). The mean flattest K, mean steepest K, and mean K significantly decreased 3 months post-ptosis surgery in Group 1; these metrics decreased but were not significant in Groups 2 and 3 after ptosis surgery. Mean corneal astigmatism decreased 3 months postop in all groups. According to the authors the mean IOL power targeting emmetropia increased in Group 1 post-ptosis surgery but remained similar in Groups 2 and 3. The authors concluded that if patients have 4 or more mm of ptosis, it significantly affects corneal curvature values and IOL power calculations. “Surgeons might consider altering their lens power choice accordingly if cataract surgery is to be sequentially followed by ptosis repair,” they wrote.
• A multicenter, retrospective cohort study evaluated the long-term visual acuity outcomes of cataract surgery in eyes with inflammatory eye disease. The study included 1,741 patients (2,382 eyes) with non-infectious eye disease who had cataract surgery with tertiary uveitis management. According to the study, visual acuity improved from a mean baseline of 20/200 to mean 20/63 within 3 months of cataract surgery, independent of anatomical location. The paper reported that eyes reaching 20/40 or better at 1 year were more likely to have scleritis or anterior uveitis, a preop VA of 20/50–20/80, inactive uveitis, have had phaco, or have had an IOL. The authors concluded that both adult and pediatric eyes with uveitis had improved visual acuity after cataract surgery that remained stable for at least 5 years postop. The research is published in the British Journal of Ophthalmology.

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Product news

• Oculus announced the launch of its GONIO ready, a gonio lens that attaches to the microscope, rather than being handheld, freeing up the surgeon’s second hand.

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