Presentations reinforce that aflibercept 8 mg demonstrated non-inferior vision gains to EYLEA at 48 weeks, with 93% and 83% of patients in PHOTON and PULSAR, respectively, maintaining dosing intervals of 12 weeks or longer after initial monthly doses
Additional new pre-specified and exploratory analyses showed aflibercept 8 mg led to sustained improvements in certain anatomical measures during the 48-week treatment period for both 12- and 16-week dosing regimens in PHOTON and PULSAR
TARRYTOWN, N.Y., Nov. 4, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced late-breaking presentations of updated results from two positive pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens, compared to EYLEA® (aflibercept) Injection, in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). The positive data from PHOTON and PULSAR were presented at the 55th Annual Scientific Session of The Retina Society in Pasadena, California.
"Investigational aflibercept 8 mg allowed the vast majority of patients to be maintained on extended dosing intervals with outcomes that were generally consistent with EYLEA across time points during the 48-week treatment period," said David Brown, M.D., FACS, Director of Research at Retina Consultants of Texas in the U.S. and a trial investigator. "Together, the PHOTON and PULSAR presentations at Retina Society show aflibercept 8 mg can potentially lead to significant and clinically meaningful outcomes with a reduced treatment burden for patients with diabetic macular edema and wet age-related macular degeneration."
As previously announced, the presentations at Retina Society showed that the PHOTON trial in DME (N=658) and the PULSAR trial in wAMD (N=1,009) met their primary endpoint, with aflibercept 8 mg demonstrating non-inferior vision gains at 48 weeks with both 12- and 16-week dosing regimens after initial monthly doses, compared to an EYLEA 8-week dosing regimen. Aflibercept 8 mg patients were rapidly initiated on extended dosing regimens and among patients who completed week 48, 93% (n=456) in PHOTON and 83% (n=628) in PULSAR maintained dosing intervals of 12 weeks or more.
In addition to data recently shared at the American Association for Ophthalmology Annual Meeting, the new efficacy analyses presented at Retina Society showed aflibercept 8 mg led to similar improvements in certain anatomical measures at 48 weeks, compared to EYLEA, despite extended dosing regimens. For the aflibercept 8 mg 12- and 16-week dosing regimens, respectively, the results showed that:
The safety of aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials. The most frequent ocular adverse events that occurred more commonly in aflibercept 8 mg versus EYLEA patients in PHOTON (aflibercept 8 mg n=491; EYLEA n=167) were cataract (3% vs. 1%), conjunctival hemorrhage (4% vs. 4%), punctate keratitis (2% vs. <1%), retinal hemorrhage (1% vs. <1%) and vitreous floaters (4% vs. 2%). In PULSAR (aflibercept 8 mg n=673; EYLEA n=336), they were cataract (4% vs. 3%) and intraocular pressure increased (3% vs. 2%). There were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in either trial.
"These data show unprecedented durability of aflibercept 8 mg in patients living with age-related macular degeneration and diabetic macular edema, who also experienced significant anatomical improvements at week 48," said Jean-François Korobelnik, Professor of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and principal trial investigator.
Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA.
Aflibercept 8 mg is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.
About the Aflibercept 8 mg Trial ProgramPHOTON in DME and PULSAR in wAMD are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or EYLEA every 8 weeks.
Patients treated with aflibercept 8 mg in both trials had 3 initial monthly doses, and patients treated with EYLEA received 5 initial monthly doses in PHOTON and 3 in PULSAR. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the study, with those results still to be assessed. Patients in all EYLEA groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.
The lead sponsors of the trials were Regeneron for PHOTON and Bayer for PULSAR.
About DME and wAMDDME is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Of the nearly 28 million American adults living with diabetes, an estimated 1.2 million have DME.
wAMD is a retinal disease that may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. An estimated 1.1 million Americans have wAMD, and this number is expected to double by 2050.
IMPORTANT EYLEA SAFETY INFORMATION AND INDICATIONSINDICATIONSEYLEA® (aflibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
CONTRAINDICATIONSFor more information, please see full Prescribing Information.
About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter.
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