Spherix Global Insights

November 03, 2022

Off-Label Avastin (Genentech) Dominates First-Line Biologic Use in Diabetic Retinopathy Despite Eylea’s (Regeneron) Best Efforts to Secure Share in the Space, According to Spherix Global Insights

While Eylea holds the second-place position, newcomer Vabysmo (Genentech) has already captured a small piece of the market and is the anticipated first switch for many current Eylea patients

EXTON, Pa., November 3, 2022 – Despite the availability of on-label products to treat diabetic retinopathy (DR), Genentech’s off-label option, Avastin, is the predominant first-line treatment.  114 ophthalmologists provided data from 357 charts of DR patients recently prescribed their first biologic (fielded from August 15 to September 26, 2022). The inaugural chart audit included in Spherix’s RealWorld Dynamix™: Biologic New Starts in Diabetic Retinopathy (US) service confirms Eylea falling short behind Genentech’s off-label product.

Genentech’s Lucentis paved the way for biologics entering the space, receiving the first-to-market approval for treatment of DR back in April 2017. However, Lucentis has been largely replaced by off-label Avastin and Eylea, claiming only a fraction of the first-line charts audited in this study compared to its two competitors.

Since Eylea’s DR approval in May 2019, Regeneron has continually aimed to improve its position through the Phase 3 PANORAMA trial, investigating both 8- and 16-week dosing in DR as well as additional research sponsored by the National Institute of Health (NIH) evaluating the agent in a 16-week dosing. Most recently, Regeneron filed for the addition of 16-week dosing to be included in the FDA approved label, potentially providing a longer treatment interval and more flexibility for individualized treatment.

While extending the treatment interval is an enticing proposition, is it really what ophthalmologists are looking for in a front-line treatment for diabetic retinopathy? Indeed, off-label Avastin has predominantly been selected for either its low copay for the patient or because it was a mandatory step-through therapy by the payer.

While those that did choose to prescribe Eylea as a first-line agent to their DR patients suggested they did so because they felt it was the best choice, those patients typically had better insurance coverage compared to that of the off-label Avastin patients. While reported preference for first-line treatment shows Eylea and Avastin neck-and-neck, actual use tells a different story as it is hard to compete with Avastin’s low price point and easy access.

Of note, Vabysmo, Genentech’s latest contribution to the retinal treatment landscape, has made small, but distinct headway in DR despite not having an official FDA label to support use in patients without diabetic macular edema (DME). A small proportion of patients are reported to have started biologic treatment on Vabysmo, with considerably more patients poised to switch from Eylea to Vabysmo within the next six months (according to the ophthalmologists’ reported patient plan).

The latest DR study from Spherix also documents the patient journey in managing the treatment of DR. The patients captured in the audit have an average age of 59, with most having been diagnosed with diabetes for at least two years. The majority engage in moderate activity and work full or part time. Approximately half of the patient records are documented by ophthalmologists as having a “good quality of life,” and many patients have high involvement in their own care and have made modifications to their lifestyle to control their A1C upon diabetes diagnosis.

Despite these efforts, most patients are still on an every 4-week dosing schedule, while very few can be extended beyond 8-weeks. This only further indicates there is a large unmet need for longer acting therapies if patients can gain access to them.

As new treatments become available and currently marketed therapies gain traction, it is likely that off-label Avastin will remain a first stop for DR patients due to its superior access, but patients will continue on to more durable treatments like Eylea and Vabysmo in the second line.

About RealWorld Dynamix™
RealWorld Dynamix™: Biologic New Starts in Diabetic Retinopathy (US) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~500 patients. The report uncovers the “why” behind treatment decisions, will include year-over-year trending to quantify key aspects of market evolution, and integrates specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select dermatology, gastroenterology, nephrology, neurology, ophthalmology, and rheumatology markets.

All company, brand or product names in this document are trademarks of their respective holders.

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