Apellis Ushers in a New Era of Geographic Atrophy Treatment with First Ever Approval, According to Spherix Global Insights

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Feb 28, 2023, 12:30 ET

Spherix Global Insights surveyed 85 US ophthalmologists, revealing awareness of Apellis's newly approved GA therapy, Syfovre is high, as are intentions to trial the agent

EXTON, Pa., Feb. 28, 2023 /PRNewswire/ -- Apellis Pharmaceuticals recently made history with the approval of Syfovre (pegcetacoplan) for the treatment for Geographic Atrophy (GA). GA is an advanced form of dry age-related macular degeneration (AMD) in which patients develop regions of the retina where cells die (lesions) resulting in blind spots in the visual field. This can cause a great disruption to patients' independence, affecting their ability to read, drive, and even see faces. Usually, once geographic atrophy starts, the region of atrophy expands slowly over several years until the central vision is lost. This devastating disease is estimated to affect >5 million people worldwide and approximately one-million patients in the U.S₁. Until now, patients had no treatment options.

Syfovre has been approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days. In the OAKS and DERBY studies in which the recent approval was based, Syfovre reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit occurring between months 18-24₂.

Spherix Global Insights recently conducted a pulse study with 85 US ophthalmologists to get an initial read on their perspective of this historic approval. Both aided and unaided awareness of Syfovre's FDA approval was high with most reporting having learned of the event through online news feeds and colleagues. A sizable portion of those surveyed also reported communications from Apellis or a Syfovre representative.

Looking specifically to GA patient types, ophthalmologists are most willing to prescribe Syfovre to those with significant vision loss in one eye and foveal encroachment in the other. There is more uncertainty when considering prescribing the agent to a GA patient that also has neovascular AMD (nAMD) in the same eye. While ophthalmologists have many years of experience treating nAMD, it is uncommon to administer two intravitreal injections in the same eye on the same day, leaving the logistics of treating both conditions as uncharted territory.

Virtually all surveyed ophthalmologists are willing to prescribe Syfovre at some point in the future, with only a minuscule proportion reporting no intention of ever prescribing. Specifically, the majority intend to trial the agent within the next six months.

Syfovre's 25-60-day flexible dosing schedule is considered an advantage by most ophthalmologists surveyed; however, reactions to how they intend to dose Syfovre are mixed. Indeed, half report they will initiate dosing on an every 60-day regimen, though some will start monthly with the intention of ultimately extending, while others will stick to monthly dosing indefinitely. As noted by one respondent, "This label leaves a lot of interpretation by the treating physician."

With fairly frequent dosing, even at the greatest extended option, patients will need to be seen on a regular cadence. Ophthalmologists also agree their GA referrals will increase now that Syfovre is available; however, even with the increased visits and referrals, they do not feel that it will strain the capacity of the practice. Respondents are less certain regarding their confidence in Apellis to provide their practice with the support it will need to fully utilize the new agent. While most ophthalmologists agree Syfovre will provide some value to GA patients, Apellis will play a vital role educating physicians on how to best approach their patients about this treatment.

Throughout 2023 into 2024, Spherix will be tracking the evolution of the US GA market via Launch Dynamix^™ service. Through partnership with Spherix's vast network of ophthalmologists, Spherix will collect monthly data on awareness, familiarity, use and uptake, timeline to trial, promotional effort, managed care trends, and projected use. On a quarterly basis, the company will conduct a deep dive into barriers, promotion, patient types, patient engagement, and the managed care experience from the perspective. As other therapies are approved in GA (Iveric Bio's investigational treatment avacincaptad pegol is currently under review with the FDA with an expected action date of August 19, 2023), Spherix will also track those agents closely with the ability to benchmark any future market entries to Syfovre's trajectory.

About Launch Dynamix^™

Launch Dynamix^™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.

About Spherix Global Insights

Spherix Global Insights is a leading provider of market research, business 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 https://www.spherixglobalinsights.com/ or connect through LinkedIn and Twitter.

Spherix Global Insights Contacts

Chrystal Ferguson, Senior Insights Director, Ophthalmology
[email protected]

Scott Upham, Corporate Communications
[email protected]

NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement by any company, brand, or product aforementioned.

SOURCE Spherix Global Insights