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Kicking off November 2023, the 127th Annual American Academy of Ophthalmology (AAO) Meeting set the stage for a month filled with significant updates in eye care.
In November, the US Food and Drug Administration (FDA) initiated a voluntary recall of eye drops by major brands, such as CVS and Target, following safety concerns, particularly regarding the risk of eye infection. Simultaneously, the FDA revamped the regulatory pathways for two new therapies, indicating landscape developments expected in 2024.
At AAO 2023, new data from pivotal phase 3 trials continued the ongoing discourse on recently approved agents targeting geographic atrophy (GA). Both pegcetacoplan injection (SYFVORE) and avacincaptad pegol (IZERVAY) continued to show escalating treatment efficacy in patients afflicted by this incapacitating sight-threatening condition.
A prevailing focus in medicine, notably within ophthalmology, centers around understanding and addressing disparities in care. Analyses presented at AAO 2023 indicated progress in mitigating these disparities, with ongoing efforts to close this care divide.
Here are 7 key stories from our coverage of ophthalmology from November 2023.
FDA News
FDA Announces Recall of Eye Drops from Leading Brands Over Safety Concerns
On November 15, 2023, the FDA announced a nationwide recall of 27 eye drop products, including some sold at CVS, Rite Aid, and Target, for potential safety reasons, including eye infection risk. The drops, voluntarily recalled by manufacturing company Kilitch Healthcare India Limited, included all lot numbers with expirations ranging from November 2023 to September 2025.
The recall followed a warning sent out by the FDA on October 27, 2023, recommending manufacturers recall all lots, owing to insanitary conditions and positive bacterial test results from environmental sampling of critical drug production areas.
Oral APX3330 Receives FDA Nod for Phase 3 Endpoint in Diabetic Retinopathy
A successful end-of-phase 2 meeting between the FDA and Ocuphire Pharma, Inc. supported the advancement of oral APX3330 into phase 3 trials for diabetic retinopathy. Announced on November 2, 2023, the agreement referenced the phase 3 primary endpoint of 3-step worsening on binocular diabetic retinopathy severity scale (DRSS) score.
The end-of-phase 2 meeting was supported by ZETA-1 trial results. Despite missing the primary endpoint of ≥2-step DRSS improvement, more placebo-treated patients had ≥3-step worsening on binocular DRSS from baseline, compared to APX3330-treated patients, at 24 weeks.
Per an FDA recommendation, Ocuphire will submit a Special Protocol Assessment to agree on the clinical trial protocol and statistical analysis plan for the phase 3 trial program.
Ophthalmic Bevacizumab Faces Revised Regulatory Path After Type A Meeting
After receiving a Complete Response Letter (CRL) in August 2023, Outlook Therapeutics has announced the receipt of the official minutes from a Type A meeting with the FDA, discussing the Biologics License Application for ONS-5010, or bevacizumab-vikg (LYTENAVA), for the treatment of wet age-related macular degeneration (AMD).
The company is required to complete an additional adequate and well-controlled study to support the BLA for ONS-5010. The FDA has informed the company it can conduct a 3-month non-inferiority study assessing ONS-5010 versus ranibizumab among treatment-naive patients with wet AMD, with a primary efficacy endpoint at 60 days.
Both parties identified necessary approaches to resolve Chemistry Manufacturing and Controls issues cited in August’s CRL.
GA Pipeline Updates
Charles Wykoff, MD, PhD: Increasing Effects of Pegcetacoplan in GALE Study
New 3-year GALE extension trial data showed increasing treatment effects with pegcetacoplan injection (SYFOVRE) among patients with GA secondary to AMD. Results from the extension trial showed pegcetacoplan reduced GA lesion growth with both monthly (35%) and every other month (24%), compared to the projected sham arm (P <.0001).
The complement C3 inhibitor also reduced GA lesion growth by 19% (P <.0001) after 1 year of pegcetacoplan treatment, compared to the sham treatment period, in individuals who crossed over from the sham group.
“I think these are the conversations that clinicians are having across the country and some patients are interested in engaging with [pegcetacoplan injection], knowing they’re not going to see better, but that you’re going to slow the progression of the disease,” said Charles C. Wykoff, MD, PhD, director of clinical research, Retina Consultants of Texas, in an interview with HCPLive.
Arshad Khanani, MD: Two-Year Results from GATHER2 Trial
Two-year results from the phase 3 GATHER2 clinical trial showed avacincaptad pegol (IZERVAY) continued to reduce the rate of geographic atrophy (GA) lesion growth in patients with GA secondary to AMD and more than doubled over 2 years.
Monthly dosing showed a statistically significant year-over-year reduction of 14% in the mean rate of GA growth from baseline versus sham (P = .0165). Every-other-month dosing, after a year of monthly dosing, led to a reduction of 19% in the mean GA growth rate at 2 years versus sham (P = .0015).
“The two-year data from the GATHER2 study shows that every-other-month dosing can continue to benefit our patients with GA, and that’s important, as it can decrease the treatment burden,” Arshad M. Khanani, MD, director of clinical research at Sierra Eye Associates, told HCPLive.
Eye Care Disparities
Durga Borkar, MD: Trial Eligibility Race Issues for Treatment Naïve Diabetic Macular Edema
Clinical trial eligibility criteria using a hemoglobin A1c (HbA1c) of ≤10.0 excluded a significantly higher number of Black participants with diabetic macular edema (DME), than White participants, according to a new analysis.
A total of 12,782 individuals were recruited from the Optum Claims database for analysis. Of the eligible participants, 6864 were White, 2327 were Black, 2904 were Hispanic, and 688 were Asian. The breakdown of HbA1c < 10% for each race was 87.8% White (n = 6024; P < .001), 81.9% Black (n = 1906; P <.001), 82.4% Hispanic (n = 2393; P <.001, and 90.4% Asian (n = 622; P = .04).
“This study suggests one of the ways that we may potentially increase diversity in clinical trials is by taking a closer look at our inclusion and exclusion criteria and the differential impacts they may have on certain populations and to do this before a clinical trial event starts,” said Durga Borkar, MD, a vitreoretinal surgeon and director of clinical data science at Duke Eye Center, in an interview with HCPLive.
Julia A. Haller, MD: Disparities in Diabetic Macular Edema, Retinal Vein Occlusion Treatment
Disparities by race and gender persist among diabetic macular edema (DME) and retinal vein occlusion (RVO) treatment, as a new analysis found Black, Asian, and female patients received fewer treatments than White and male patients.
The analysis of the AAO Intelligent Research in Sight (IRIS) database revealed significant differences in the numbers of patients with DME and RVO treated with anti-VEGF injections in the first year post-diagnosis. Those who were identified as Black or Asian, women, or >70 years old, as well as patients with visual acuity outside of the <20/40 to 20/200 range were less likely to receive treatment.
“My main takeaway is that we’re making progress, but we still have a long way to go,” said Julia Haller, MD, Wills Eye Hospital, in an interview with HCPLive. “Eliminating healthcare disparities is a huge task for all of us in ophthalmology. Fixing disparities is a complicated problem and it’s one worthy of attention.”
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