A high percentage of GA patients are either being seen for the first time, or not returning for follow-up visits due to lack of options according to non-treating clinicians, making the need for timely referrals essential for getting new treatments to patients. With Apellis' pegcetacoplan nearing the finish line and Iveric Bios' avacincaptad pegol not far behind, treating ophthalmologists have started to consider who might come out on top
EXTON, Pa., Nov. 29, 2022 /PRNewswire/ -- Spherix Global Insights ("Spherix") recently surveyed 131 US ophthalmologists (81 of whom personally administer intravitreal injections) and 50 optometrists and followed up with 8 qualitative interviews to assess the current and future treatment paradigm of geographic atrophy (GA). This inaugural wave of research is included in Spherix's Market Dynamix™ service and highlights metrics on patient management, while also delving deeper into the opportunity for agents in development.
GA has long been considered an untreatable condition, with devastating consequences of disease progression (blindness and an inevitable loss of independence) well documented from the ophthalmology community. There has been little hope for patients suffering from this disease, that is, until recent positive late-stage data from Apellis and Iveric Bio has reignited the conversation.
Apellis has filed for FDA approval of pegcetacoplan, a targeted C3 therapy, for the treatment of GA with a current action date of February 26th, 2023. Iveric intends to file for their investigational complement C5 inhibitor, avacincaptad pegol, with the FDA in Q1 of 2023 – meaning two approved agents in GA may become a reality in the US by the end of 2023.
While both treating and non-treating ophthalmologists believe there is a high unmet need for new treatment options in GA, optometrists are not as convinced (though they do see the importance of treating early). Additionally, optometrists are less likely than ophthalmologists to believe asymptomatic GA patients will be likely to receive intravitreal injection proactively.
In the qualitative interviews, injecting ophthalmologists elaborated that GA is a chronic condition that can progress slowly; however, that does not translate into the luxury to delay evaluation for treatment. Ophthalmologists suggest "empathy for what patients go through with GA" is going to be necessary for referrers to fully understand the appropriate treatment approach. Some respondents speculate that even the retina community will need time to fully understand how and when to treat these patients.
Within this study, a deep dive analysis included agent profiles of Apellis' pegcetacoplan and Iveric's avacincaptad pegol – including potential limitations, clinical relevance of Phase 3 data, likelihood to prescribe, benefit to patient subgroups, timeline to prescribe after approval, percent of candidates, risk/benefit profile, and drivers for initiation.
Qualitative interviews suggested respondents did not see a clear differentiation between the two late-stage agents but would be inclined to favor the one that received the broadest label and best access. However, when asked if limited to one agent, pegcetacoplan came out on top.
Ophthalmologists are not particularly aware of the other pipeline agents in development, given the conversation has been dominated by Apellis and Iveric Bio's agents in anticipation of their potential near-term approval in GA.
Several other pipeline therapies were provided to respondents:
- ANX007 (Annexon Biosciences)
- Danicopan (Alexion Pharmaceuticals)
- Elamipretide (Stealth Biotherapeutics)
- GS030 (GenSight Biologics)
- GT005 (Gyroscope)
- HMR59 (Hemera Bioscience partnered with Janssen)
- Ionis-FB-Lrx (Ionis Pharmaceuticals in partnership with Roche/Genentech)
- Tinlarebant (Lin Biosciences)
- PPY988 (Novartis)
- OpRegen (Lineage Cell Therapeutics)
Awareness and familiarity of each pipeline agent, along with familiarity of the agents' manufacturers, are assessed in the Market Dynamix™ report.
Given prior exposure to failed trials with complement inhibitors in the past several years (the same mechanism of action of both pegcetacoplan and avacincaptad pegol, that this time is garnering success), some skepticism was expressed over the clinical relevance of the late-stage agents. This suggests newer approaches such as Gyroscope Therapeutics' GT005, an AAV2-based gene therapy, could be the direction to follow.
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the near-term. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.
Spherix Global Insights is a leading provider of market intelligence and advisory services to the global life sciences industry.
The company's unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.
A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology, and ophthalmology.
To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter.
Spherix Global Insights Contacts:
Chrystal Ferguson, Ophthalmology Franchise Head
[email protected]
Scott Upham, Corporate Communications
[email protected]
SOURCE Spherix Global Insights
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