Catch up with what Optometry Times®' shared this week:

Optometry news

Pegcetacoplan approved by FDA for the treatment of geographic atrophy

By Lynda Charters; Emily Kaiser, Assistant Managing Editor; Kassi Jackson, Editor

The FDA approved intravitreal pegcetacoplan (SYFOVRE; Apellis) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) based on the results of the 24-month phase 3 data submitted in its New Drug Application in November 2022.

“The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, MD, PhD, lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center, in a press release. “Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With SYFOVRE, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.”

Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of GA.

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Addressing symptom relief of optic neuritis in multiple sclerosis

By Brenda Montecalvo, OD

Multiple sclerosis (MS) can be a demanding and disabling condition in which the body’s immune system attacks nerves in the brain and spinal cord. Symptoms can be highly patient specific, but visual problems are often 1 of the first conditions of MS to be seen clinically.¹ Unfortunately, many patients may suffer from relapsing-remitting MS, demonstrated alternating periods of symptoms and recovery.¹

Optic neuritis can be an early warning sign of MS, which may not impact life span so much as a patient’s quality of life.^2,3 While eye care professionals (ECPs) are aware of optic neuritis, there can be some clinical challenges to consistently provide optimal eyesight to patients with MS who suffer from flare-ups.

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Keratoconus and perfect vision: Is it possible?

By William B. Trattler, MD; Elise Kramer, OD, FAAO, FSLS

Most people with keratoconus (KC) have myopic astigmatism. As the disease progresses, the myopia and/or astigmatism may increase over months and years and as it becomes even more advanced, the patient will lose best-corrected visual acuity. Often, it is worsening vision or the inability to correct the patient to 20/20 that leads to the initial referral to a cornea specialist or a contact lens specialist.

By contrast, the conventional wisdom is that we really don’t expect to see KC in an emmetrope or even in a low ametrope. However, there are patients with frank keratoconus who actually have reasonably good vision without correction or who can achieve 20/20 vision with a simple soft contact lens or spectacle correction. If these patients undergo topography/tomography imaging, the cone will be clearly visible even though there might otherwise not have been any other red flags.

For example, an 18-year-old low myope who had good vision in his habitual glasses that had been prescribed elsewhere presented with viral conjunctivitis with 2+ injection and follicles in both eyes. He was started on a topical steroid OU. One week later he returned, complaining of a reduction in vision. Upon examination, visual acuity was reduced to only 20/60 OD and 20/40 OS with his current glasses. Since he had developed subepithelial infiltrates, corneal topography was performed and, surprisingly, revealed keratoconus in both eyes (Figure 1). There was no family history and no prior suspicion of keratoconus. The steroid was continued and the infiltrates resolved. After repeat imaging that demonstrated progression, he underwent cross-linking in both eyes a few months later.

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Orasis Pharmaceuticals’ NDA for CSF-1 for presbyopia accepted by FDA

By Emily Kaiser, Assistant Managing Editor

Orasis Pharmaceuticals announced that the U.S. Food and Drug Adminstration (FDA) has accepted its New Drug Application (NDA) for its investigational low dose pilocarpine hydrochloride 0.4% (CSF-1) eye drop for the treatment of presbyopia. The Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023 was assigned to the novel eye drop.¹

“We are encouraged by the acceptance of our NDA filing as we progress towards our mission of reshaping vision possibilities for the millions of people in the U.S. living with presbyopia, or blurry near-vision,” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals, in a press release. “We look forward to working with the FDA towards approval and commercial launch of CSF-1.”

The acceptance of the NDA was decided based on the results of the Phase 3 NEAR-1 and NEAR-2 clinical trials, which investigated safety and efficacy of CSF-1 in over 600 patients. By day 8 of the trial, both trials had met primary and secondary endpoints. The investigational eye drop achieved a statistically significant 3-line or more gain in distance-corrected visual acuity and the investigators reported no loss of 1-line or more in distance visual acuity. Only 2.6% of participants reported moderate adverse events and all other adverse events were mild; the most common treatment-related events included headache and installation site pain, which occurred in 6.8% and 5.8% of participants, respectively.

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Controversies in Modern Eye Care 2023: Back to in-person and better than before

By Arjan Hura, MD; Kassi Jackson, Editor

Arjan Hura, MD, refractive, cataract, and anterior segment surgeon at the Maloney-Shamie Institute, and co-chair of the 17th annual Controversies in Modern Eye Care meeting held April 30, 2023 in Los Angeles, caught up with Optometry Times®' editor Kassi Jackson to give a sneak peek.

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Practical management EP 5: Utilizing digital platforms

By Maria Sampalis, OD; Kassi Jackson, Editor

Maria Sampalis, OD, owner of Sampalis Eye Care in Cranston and Providence, Rhode Island, sat down with Optometry Times®' editor Kassi Jackson to talk all-things practice management, touching on digital platforms and the importance of utilizing them

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