Early intervention with Eylea has positive results in PANORAMA trial

More patients treated with Eylea than sham had an improvement in Diabetic Retinopathy Severity Scale scores.

Patients in the PANORAMA trial who underwent early intervention with Eylea experienced improvements in diabetic retinopathy severity, and the majority experienced prevention of serious vision-threatening complications.

Trial investigator Charles C. Wykoff, MD, PhD, presented the 1-year results of the phase 3 trial at Bascom Palmer Eye Institute’s Angiogenesis, Exudation, and Degeneration 2019 symposium in Miami. The double-masked, randomized trial included patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) treated with Eylea (aflibercept, Regeneron) every 16 weeks (135 participants) after four loading doses or every 8 weeks (134 participants) after five loading doses or with a sham control (133 participants).

Significant DRSS improvements

Moderately severe to severe NPDR was defined as Diabetic Retinopathy Severity Scale (DRSS) scores from 47 to 53.

Charles C. Wykoff
Charles C. Wykoff

“PANORAMA adds significantly to our understanding of how to manage NPDR without DME, as it is the first prospective trial involving high-risk NPDR eyes with moderately severe to severe NPDR since the landmark ETDRS trial of the 1980s, before we had pharmacologic treatments for DME,” Wykoff told Ocular Surgery News.

The primary endpoint was the proportion of patients who experienced a two-step or greater improvement in DRSS level from baseline for the combined Eylea treatment groups at week 24 and for each Eylea group separately at week 52.

The secondary endpoints assessed whether Eylea reduced vision-threatening complications or development of central-involved diabetic macular edema and the impact on visual acuity improvement, safety or other anatomic effects.

At 52 weeks, 65.2% of Eylea participants treated every 16 weeks and 79.9% of Eylea participants treated every 8 weeks experienced a two step or greater improvement in DRSS from baseline. The improvements in the Eylea-treated groups were statistically significant compared with the 15% of sham group participants who experienced a two step or greater improvement.

Limited vision-threatening events

Through 1 year, 40.6% of the sham treatment subjects developed a vision-threatening complication or center-involved diabetic macular edema compared with 9.6% of the Eylea subjects treated every 16 weeks and 11.2% of the Eylea subjects treated every 8 weeks.

“Improvements in diabetic retinopathy severity achieved with aflibercept loading doses were maintained through 1 year with every 16-week re-treatments, a management approach that could realistically be achieved in the real world,” Wykoff said.

Eylea every 16 weeks resulted in a mean 1.6 ETDRS letter gain, and Eylea every 8 weeks resulted in a mean 1.5 ETDRS letter gain at week 52 compared with a mean of 0.3 ETDRS letters for the sham-treated group.

“I look forward to additional data from PANORAMA as this is a 2-year trial, and in the second year, the every 16-week dosing arm continues fixed aflibercept dosing while the every 8-week dosing arm transitions to PRN aflibercept re-treatment,” Wykoff said. – by Robert Linnehan

References:

One-year results from positive phase 3 Eylea trial in diabetic retinopathy presented at Angiogenesis symposium. www.prnewswire.com/news-releases/one-year-results-from-positive-phase-3-eylea-trial-in-diabetic-retinopathy-presented-at-angiogenesis-symposium-300792822.html. Published Feb. 9, 2019. Accessed Feb. 12, 2019.

Regeneron presents positive data from PANORAMA trial. www.healio.com/ophthalmology/retina-vitreous/news/online/%7B148e238b-9ab5-4cb4-ad7a-d852368bb1d4%7D/regeneron-presents-positive-data-from-panorama-trial. Published Feb. 14, 2019.

Wykoff CC. Intravitreal aflibercept for moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The phase 3 PANORAMA study. Presented at: Angiogenesis, Exudation, and Degeneration 2019; Feb. 9, 2019; Miami.

For more information:

Charles C. Wykoff, MD, can be reached at Retina Consultants of Houston, 6560 Fannin St., Suite 750, Houston, TX 77030; email: ccwmd@houstonretina.com.

Disclosures: Wykoff reports he is a consultant for Alimera Sciences, Allegro, Allergan, Alnylam, Apellis, Bayer, Clearside Biomedical, DORC, EyePoint, Genentech/Roche, Kodiak, Notal Vision, Novartis, ONL Therapeutics, PolyPhotonix, Recens Medical, Regeneron, Regenxbio and Santen; is a researcher for Allergan, Apellis, Clearside Biomedical, EyePoint, Genentech/Roche, Neurotech, Novartis, Opthea, Regeneron, Regenxbio, Samsung and Santen; and is a speaker for Regeneron.

Patients in the PANORAMA trial who underwent early intervention with Eylea experienced improvements in diabetic retinopathy severity, and the majority experienced prevention of serious vision-threatening complications.

Trial investigator Charles C. Wykoff, MD, PhD, presented the 1-year results of the phase 3 trial at Bascom Palmer Eye Institute’s Angiogenesis, Exudation, and Degeneration 2019 symposium in Miami. The double-masked, randomized trial included patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) treated with Eylea (aflibercept, Regeneron) every 16 weeks (135 participants) after four loading doses or every 8 weeks (134 participants) after five loading doses or with a sham control (133 participants).

Significant DRSS improvements

Moderately severe to severe NPDR was defined as Diabetic Retinopathy Severity Scale (DRSS) scores from 47 to 53.

Charles C. Wykoff
Charles C. Wykoff

“PANORAMA adds significantly to our understanding of how to manage NPDR without DME, as it is the first prospective trial involving high-risk NPDR eyes with moderately severe to severe NPDR since the landmark ETDRS trial of the 1980s, before we had pharmacologic treatments for DME,” Wykoff told Ocular Surgery News.

The primary endpoint was the proportion of patients who experienced a two-step or greater improvement in DRSS level from baseline for the combined Eylea treatment groups at week 24 and for each Eylea group separately at week 52.

The secondary endpoints assessed whether Eylea reduced vision-threatening complications or development of central-involved diabetic macular edema and the impact on visual acuity improvement, safety or other anatomic effects.

At 52 weeks, 65.2% of Eylea participants treated every 16 weeks and 79.9% of Eylea participants treated every 8 weeks experienced a two step or greater improvement in DRSS from baseline. The improvements in the Eylea-treated groups were statistically significant compared with the 15% of sham group participants who experienced a two step or greater improvement.

Limited vision-threatening events

Through 1 year, 40.6% of the sham treatment subjects developed a vision-threatening complication or center-involved diabetic macular edema compared with 9.6% of the Eylea subjects treated every 16 weeks and 11.2% of the Eylea subjects treated every 8 weeks.

“Improvements in diabetic retinopathy severity achieved with aflibercept loading doses were maintained through 1 year with every 16-week re-treatments, a management approach that could realistically be achieved in the real world,” Wykoff said.

Eylea every 16 weeks resulted in a mean 1.6 ETDRS letter gain, and Eylea every 8 weeks resulted in a mean 1.5 ETDRS letter gain at week 52 compared with a mean of 0.3 ETDRS letters for the sham-treated group.

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“I look forward to additional data from PANORAMA as this is a 2-year trial, and in the second year, the every 16-week dosing arm continues fixed aflibercept dosing while the every 8-week dosing arm transitions to PRN aflibercept re-treatment,” Wykoff said. – by Robert Linnehan

References:

One-year results from positive phase 3 Eylea trial in diabetic retinopathy presented at Angiogenesis symposium. www.prnewswire.com/news-releases/one-year-results-from-positive-phase-3-eylea-trial-in-diabetic-retinopathy-presented-at-angiogenesis-symposium-300792822.html. Published Feb. 9, 2019. Accessed Feb. 12, 2019.

Regeneron presents positive data from PANORAMA trial. www.healio.com/ophthalmology/retina-vitreous/news/online/%7B148e238b-9ab5-4cb4-ad7a-d852368bb1d4%7D/regeneron-presents-positive-data-from-panorama-trial. Published Feb. 14, 2019.

Wykoff CC. Intravitreal aflibercept for moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The phase 3 PANORAMA study. Presented at: Angiogenesis, Exudation, and Degeneration 2019; Feb. 9, 2019; Miami.

For more information:

Charles C. Wykoff, MD, can be reached at Retina Consultants of Houston, 6560 Fannin St., Suite 750, Houston, TX 77030; email: ccwmd@houstonretina.com.

Disclosures: Wykoff reports he is a consultant for Alimera Sciences, Allegro, Allergan, Alnylam, Apellis, Bayer, Clearside Biomedical, DORC, EyePoint, Genentech/Roche, Kodiak, Notal Vision, Novartis, ONL Therapeutics, PolyPhotonix, Recens Medical, Regeneron, Regenxbio and Santen; is a researcher for Allergan, Apellis, Clearside Biomedical, EyePoint, Genentech/Roche, Neurotech, Novartis, Opthea, Regeneron, Regenxbio, Samsung and Santen; and is a speaker for Regeneron.