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News - FDA Approves EYLEA HD for Macular Edema Following Retinal Vein Occlusion and Expands Monthly Dosing Options

December 2025 | Katie Ogden, Portfolio Manager – Pharma, SAE Media Group

Regeneron Pharmaceuticals announced that the FDA has approved EYLEA HD (aflibercept) Injection 8 mg for the treatment of macular edema following retinal vein occlusion (RVO). The approval includes dosing up to every eight weeks after an initial monthly dosing period, making EYLEA HD the first and only FDA-approved treatment for RVO with this extended interval option. The FDA also approved a monthly dosing option across all indications, providing physicians greater flexibility to personalize care for patients.


“We believe these approvals further position EYLEA HD as a treatment of choice for certain retinal diseases and underscore our relentless commitment to meeting the needs of patients and the retina specialists who treat them,” said George D. Yancopoulos, M.D., Ph.D., co-Founder, Board Co-Chair, President and Chief Scientific Officer at Regeneron. “EYLEA HD is the first treatment for retinal vein occlusion that can potentially cut the number of injections that patients receive in half compared to existing therapies. And with the addition of a monthly dosing option for all four approved EYLEA HD indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”


The approval for RVO is supported by data from the Phase 3 QUASAR trial, which compared EYLEA HD to EYLEA (aflibercept) Injection 2 mg. At 36 weeks, patients receiving EYLEA HD every eight weeks after three or five initial monthly doses achieved non-inferior visual acuity gains compared to those on EYLEA every four weeks. Results were consistent across central, branch, and hemiretinal vein occlusions. Common adverse reactions (≥3%) included increased intraocular pressure, blurred vision, cataract, conjunctival hemorrhage, ocular discomfort, and vitreous detachment.


EYLEA HD is approved for dosing intervals of eight to 16 weeks for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), eight to 12 weeks for diabetic retinopathy (DR), and every eight weeks for RVO, following initial monthly doses. Some patients may require resuming monthly dosing if extended intervals do not maintain response.


Regeneron continues to address manufacturing considerations for the EYLEA HD pre-filled syringe and plans to submit an application for an alternate manufacturing filler by January 2026. The company also offers patient support through EYLEA 4U, which provides insurance guidance and financial assistance for eligible patients.


EYLEA HD, jointly developed by Regeneron and Bayer AG, builds on more than a decade of experience with EYLEA and aims to reduce injection frequency while maintaining efficacy and safety for serious retinal conditions.
 



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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