Aflibercept 8 mg first to achieve extended injection intervals of 16 weeks in up to 89% of patients

Berlin, September 8, 2022 – Bayer AG at the present time announced the major endpoint was once met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with neovascular (wet) age-associated macular degeneration (nAMD) and diabetic macular edema (DME) at week forty eight. The Section III PULSAR trial in nAMD and Section II/III PHOTON trial in DME evaluated the non-inferiority of the 2 aflibercept 8 mg extended-dosing regimens by manner of easiest corrected visible acuity (BCVA), when put next with Eylea^® (aflibercept 2 mg) dosed every 8-week following preliminary month-to-month doses. In these trials, the protection of aflibercept 8 mg was once in step with the smartly-established safety profile of Eylea. Bayer will submit these recordsdata to regulatory authorities exterior of the U.S..

“These groundbreaking results are wonderful recordsdata for patients. These outcomes dangle proven that aflibercept 8 mg no longer easiest improved vision with much less frequent injections, however also demonstrated a the same safety profile to Eylea,” acknowledged Jean-François Korobelnik, Professor of Ophthalmology and Head of the Department of Ophthalmology at College Clinical institution of Bordeaux in France and a trial investigator.

“These pivotal aflibercept 8 mg trials demonstrated that nearly 90% of patients with diabetic macular edema and nearly 80% of patients with wet age-associated macular degeneration were ready to abet a 16-week dosing regimen,” acknowledged David Brown, M.D., FACS, Director of Learn at Retina Consultants of Texas in the U.S. and a trial investigator. “These unprecedented sturdiness recordsdata coupled with a safety profile in step with that of Eylea make stronger aflibercept 8 mg as a doubtless contemporary long-established-of-care in these diseases.”

Aflibercept 8 mg was once investigated in two double-masked, energetic-controlled pivotal trials – PULSAR (n=1009) in nAMD and PHOTON (n=658) in DME – to mediate efficacy and safety when put next with Eylea. Each and each trials were performed in a pair of facilities globally with the same designs and endpoints. At forty eight-weeks, each and each trials met their major endpoints of non-inferiority of aflibercept 8 mg to Eylea. Extra results were as follows:

In the aflibercept 8 mg 16-week dosing groups, 77% of nAMD patients in PULSAR (n=312) and 89% of DME patients in PHOTON (n=156) were ready to abet 16-week injection intervals with an common of 5 injections in the first year.

In the aflibercept 8 mg 12-week dosing groups, 79% of nAMD patients in PULSAR (n=316) and 91% of DME patients in PHOTON (n=300) were ready to abet 12-week injection intervals with an common of 6 injections in the first year.

In a pooled diagnosis of aflibercept 8 mg dosing groups, 83% of nAMD patients in PULSAR and 93% of DME patients in PHOTON maintained 12-week dosing or longer.

The protection of aflibercept 8 mg in each and each trials was once the same to the smartly-established safety profile of Eylea and in step with the protection of Eylea noticed in previous scientific trials. Evaluating aflibercept 8 mg to Eylea, the rates of noteworthy ocular adversarial events were 1.6% versus 0.6% in PULSAR and zero.6% versus 0.6% in PHOTON. The rates of intraocular irritation for aflibercept 8 mg when put next with Eylea were 0.7% versus 0.6% in PULSAR and zero.8% versus 0.6% in PHOTON. There were no clinically relevant variations in intraocular stress between the remedy groups. In each and each trials, there were no cases of retinal vasculitis and no contemporary safety indicators.

“These recordsdata trace a recent period, because the extended dosing intervals of aflibercept 8 mg severely decreased the remedy burden for a colossal majority of patients when put next with the extra intensive injection frequency currently required,” acknowledged Dr. Christian Rommel, Member of the Executive Committee of Bayer`s Pharmaceutical Division and Head of Learn and Construction. “All of this was once carried out whereas improving and asserting vision with comparable safety to Eylea.”

Detailed efficacy and safety recordsdata from PHOTON and PULSAR are planned for presentation at an upcoming clinical meeting.

Aflibercept 8 mg is being collectively developed by Bayer and Regeneron. Regeneron maintains atypical rights to Eylea and aflibercept 8 mg in the US. Bayer has licensed the atypical marketing rights exterior the US, where the companies half equally the earnings from gross sales of Eylea.

Aflibercept 8 mg is investigational, and its safety and efficacy dangle no longer yet been evaluated by any regulatory authority.

About nAMD and DME

Neovascular (wet) age-associated macular degeneration (nAMD) is an witness disease that progresses instantly and if left untreated can lead to vision loss in as tiny as three months. nAMD is one in every of the leading causes of irreversible blindness and vision impairment across the arena. nAMD may perhaps perhaps well merely impact of us as they age. It occurs when irregular blood vessels grow and leak fluid under the macula, the segment of the witness to blame for fascinating central vision and seeing most attention-grabbing-making an try detail. This fluid can harm and scar the macula, that will trigger vision loss. 196 million of us worldwide live with AMD – it’s miles anticipated that this identify will amplify to 288 million by 2040.

Diabetic macular edema (DME) is a overall complication in eyes of of us residing with diabetes. DME occurs when high ranges of blood sugar lead to broken blood vessels in the witness that leak fluid into the macula. This may perhaps lead to vision loss and, in some cases, blindness. Globally, 146 million of us are currently residing with diabetic retinopathy (DR), that will dangle staunch into a extra serious situation which is diabetic macular edema (DME).

About Bayer

Bayer is a world enterprise with core competencies in the lifestyles science fields of health care and nutrition. Its products and providers and products are designed to assist of us and the planet thrive by supporting efforts to grasp the critical challenges offered by a rising and getting previous world inhabitants. Bayer is committed to riding sustainable development and generating a obvious impact with its companies. On the the same time, the Crew goals to amplify its incomes energy and form cost thru innovation and boost. The Bayer trace stands for belief, reliability and quality in the course of the arena. In fiscal 2021, the Crew employed around 100,000 of us and had gross sales of 44.1 billion euros. R&D costs earlier than particular objects amounted to 5.3 billion euros. For added recordsdata, trek to www.bayer.com.

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