New subgroup data and further analyses of the aflibercept 8 mg clinical trial program to highlight durability results of extended dosing intervals, patient characteristics, and efficacy and safety in wet age-related macular degeneration and diabetic macular edema

18 presentations reinforce Regeneron’s commitment to patients with serious retinal diseases

TARRYTOWN, N.Y., April 17, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and its collaborator Bayer today announced that aflibercept 8 mg and EYLEA® (aflibercept) Injection will be featured in 18 presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting from April 23-27. Among the presentations will be new subgroup data and further analyses of aflibercept 8 mg treatment from the pivotal PULSAR and PHOTON trials in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), as well as the Phase 2 CANDELA trial in wAMD.

“Our data presentations at ARVO build on the more than 20 years of industry-leading knowledge and dedicated research aimed at addressing the unmet needs of patients with serious retinal diseases,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Sciences General Medicine at Regeneron. “We look forward to sharing presentations on the efficacy and safety of EYLEA in multiple retinal diseases, as well as additional analyses of the pivotal aflibercept 8 mg trials – all of which reinforce our unwavering commitment to advancing retinal care for patients at risk of losing their vision.”

Notable podium presentations will highlight the pivotal aflibercept 8 mg trials PULSAR and PHOTON, respectively, in wAMD and DME with 48-week efficacy and safety results, in addition to an evaluation of baseline characteristics of patients randomized to aflibercept 8 mg who maintained their dosing intervals and those whose dosing intervals were shortened. A pooled safety analysis of aflibercept 8 mg across the PULSAR, PHOTON and CANDELA trials will also be presented.

Data from PHOTON and PULSAR were first presented at the American Academy of Ophthalmology’s annual meeting in September 2022. In February 2023, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg for treatment of patients with wAMD, DME and diabetic retinopathy with a target action date of June 27, 2023. Aflibercept 8 mg is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.

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 and future sales of aflibercept 8 mg following any regulatory approvals.

Aflibercept 8 mg and EYLEA presentations at ARVO:

*Bayer-run trial

About the Aflibercept 8 mg Clinical Trial ProgramPULSAR in wAMD and PHOTON in DME 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. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON.

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.

CANDELA was a Phase 2 trial investigating the safety and efficacy of aflibercept 8 mg extended dosing regimens compared to EYLEA in wAMD patients.

About wAMD and DMEwAMD 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.

DME 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.

About EYLEAEYLEA is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in ocular angiogenesis. The EYLEA safety and efficacy profile is supported by a robust body of research that includes eight pivotal Phase 3 trials, more than 11 years of real-world experience and greater than 57 million EYLEA injections globally.

IMPORTANT EYLEA SAFETY INFORMATION AND INDICATIONS

INDICATIONSEYLEA (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), Diabetic Retinopathy (DR) and Retinopathy of Prematurity (ROP) (0.4 mg [0.01 mL]).

CONTRAINDICATIONS

• EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

WARNINGS AND PRECAUTIONS

• Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.
• Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
• In infants with ROP, reactivation of abnormal angiogenesis and tortuosity may occur following treatment with EYLEA. Infants should be monitored closely after injection with EYLEA until retinal vascularization has completed or until the examiner is assured that reactivation of ROP will not occur. Treatment with EYLEA will necessitate extended periods of ROP monitoring and additional EYLEA injections and/or laser treatments may be necessary.
• There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.

ADVERSE REACTIONS

• Serious adverse reactions related to the injection procedure have occurred in