Double-Barreled Biologic for Diabetic Retinopathy Emerging

Marcia Frellick

July 10, 2019

CHICAGO — Investigators searching for new ways to manage diabetic macular edema are targeting pathways beyond vascular endothelial growth factor (VEGF), the only pathway for which there are approved therapies, and are developing treatments that can be administered less often.

Phase 2 results from the BOULEVARD trial (NCT02699450), which is comparing faricimab, the first biologic to target both the Ang-2 and VEGF pathways, with ranibizumab, will be presented at the American Society of Retina Specialists (ASRS) 2019 Annual Meeting. The drug, from Roche and Genentech, is currently in phase 3 trials.

"We're all very interested to see if we have a drug that can be used less frequently than every 8 weeks but with outcomes similar to monthly therapy, and whether the improvement in acuity gains, compared with ranibizumab (Lucentis, Genentech), is replicated in phase 3," said Lloyd Clark, MD, from the Palmetto Retina Center in West Columbia, South Carolina.

In addition, questions about the early treatment of diabetic macular edema could be answered at the meeting when two studies are presented, said Charles Wykoff, MD, PhD, from Retina Consultants of Houston, Texas, who will present several clinical updates.

We're able to turn back the clock in roughly two thirds of patients who have vision-threatening diabetic retinopathy.   Lloyd Clark, MD

Two-year results from the randomized Protocol V trial (NCT01909791), comparing aflibercept (Eylea, Regeneron), laser, and observation in patients with good vision but center-involved diabetic macular edema, will be presented by Carl Baker, MD, from the Diabetic Retinopathy Clinical Research (DRCR) network.

And 1-year prospective data from the PANORAMA trial (NCT02718326) will show the effect of different doses of aflibercept on diabetic retinopathy when treatment is started at the threshold at which vision-threatening complications are most likely to occur. Clinically relevant regression rates of retinopathy are being tracked, Clark, who led the study, told Medscape Medical News.

Clark's presentation will follow early reports that showed that "we're able to turn back the clock in roughly two thirds of patients who have vision-threatening diabetic retinopathy," he explained.

"This is incredibly important because once patients get to severe nonproliferative diabetic retinopathy, they have about a 50% chance of developing sight-threatening disease within a year. If you can back them off of that ledge, it would make sense that this is meaningful."

Although the regression is very interesting, much needs to be learned about it over the long term, he acknowledged.

Artificial intelligence has also opened up advances in the field. The first artificial intelligence tool to detect diabetic retinopathy without a physician to interpret the image or results was approved last year by the US Food and Drug Administration, as reported by Medscape Medical News.

More Screening

"The concept of using noninvasive imaging to screen for a common blinding disease, especially diseases where people are not receiving the screening they should be, makes a lot of sense," said Wykoff.

A recent national analysis showed that almost half of 300,000 insured people with type 2 diabetes and no diabetic retinopathy had not undergone an eye exam in the previous 5 years, and only one in seven had undergone the recommended annual or biennial exams, as reported by Medscape Medical News.

Another theme likely to be of interest at the meeting is how to use wide-field imaging to guide management decisions for patients with diabetic retinopathy, Wykoff pointed out.

"A lot of people now have access to wide-field imaging, so they're seeing more pathology than with imaging the posterior pole," he explained. "The question is: Now that we can see more of the retina with standardized imaging, should that be changing our management?"

Clark is a consultant for Regeneron and Genentech/Roche. Wykoff has reported relationships with Aerpio, Alimera Sciences, Allergan, Bayer, Clearside Biomedical, Genentech/Roche, Kodiak, Novartis, and Regeneron.

American Society of Retina Specialists 2019 Annual Meeting.

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