EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting

TARRYTOWN, N.Y., Feb. 08, 2025 (GLOBE NEWSWIRE) — Regeneron Prescribed drugs, Inc. (NASDAQ: REGN) in the present day introduced the primary presentation of optimistic outcomes from the Phase 3 QUASAR trial investigating EYLEA HD^® (aflibercept) Injection 8 mg for the remedy of sufferers with macular edema following retinal vein occlusion (RVO), together with these with central, department and hemiretinal vein occlusions. The info had been introduced in the present day at the digital Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2025 annual assembly and can assist the submission of a supplemental Biologics License Software to the U.S. Meals and Drug Administration (FDA) in the primary quarter of 2025.

“Retinal vein occlusion is the second commonest retinal vascular illness. Nevertheless, the present remedy paradigm of month-to-month eye injections could make it difficult for sufferers to take care of their remedy plan, probably resulting in poor adherence and imaginative and prescient loss,” stated Seenu M. Hariprasad, M.D., Chair of the Division of Ophthalmology and Visible Science, The College of Chicago. “Based mostly on these new information, aflibercept 8 mg could provide the potential to halve the variety of injections wanted, as in comparison with standard-of-care aflibercept 2 mg and different anti-VEGF therapies.”

As introduced at Angiogenesis, the QUASAR trial met its major endpoint at 36 weeks, with each teams of EYLEA HD sufferers dosed each 8 weeks attaining non-inferior visible acuity positive aspects in comparison with these receiving EYLEA^® (aflibercept) Injection 2 mg dosed each 4 weeks. The EYLEA HD outcomes had been constant throughout sufferers with department retinal vein occlusions, and these with central retinal or hemiretinal vein occlusions. Moreover, in sufferers handled with EYLEA HD by way of 36 weeks, 88% of sufferers had been in a position to maintain an 8-week dosing routine following 3 preliminary month-to-month doses, and 93% of sufferers maintained an 8-week dosing routine after finishing 5 preliminary month-to-month doses.

The security profile of EYLEA HD (n=591) was just like EYLEA (n=301) in QUASAR and remained typically constant with the recognized security profile of EYLEA HD in its pivotal trials. Ocular treatment-emergent hostile occasions (TEAEs) occurring in ≥5% of all EYLEA HD sufferers included elevated ocular strain (5%); there was one case every of endophthalmitis and retinal vasculitis. The speed of intraocular irritation was 0.5% for EYLEA HD and 1.3% for EYLEA.

Knowledge from QUASAR had been first shared in December 2024.

EYLEA HD (often called Eylea™ 8 mg in the European Union and Japan) is being collectively developed by Regeneron and Bayer AG. Within the U.S., Regeneron maintains unique rights to EYLEA and EYLEA HD. Bayer has licensed the unique advertising and marketing rights outdoors of the U.S., the place the businesses share equally the income from gross sales of EYLEA and EYLEA HD.

The security and efficacy of EYLEA HD for the remedy of RVO has not been evaluated by any regulatory authority.

(*8*)Concerning the QUASAR Trial
QUASAR is a world double-masked, active-controlled Phase 3 trial evaluating the efficacy and security of EYLEA HD in sufferers with macular edema secondary to RVO, together with these with central retinal vein occlusion, department retinal vein occlusion, or hemiretinal vein occlusion.

Within the trial, sufferers had been randomized into three teams to obtain both: EYLEA HD each 8 weeks following 3 preliminary month-to-month doses; EYLEA HD each 8 weeks following 5 preliminary month-to-month doses; or EYLEA each 4 weeks. The first endpoint was imply change in BCVA from randomization by way of week 36, as measured by the Early Remedy Diabetic Retinopathy Examine letter rating.

Patients in the EYLEA HD teams can have their dosing intervals shortened to a minimal of each 4 weeks all through the trial if protocol-defined standards for illness development are met. Dosing intervals could also be prolonged based mostly on protocol-defined standards beginning at week 32 for sufferers who obtain EYLEA or EYLEA HD after 3 preliminary month-to-month doses or at week 40 for sufferers who obtain EYLEA HD after 5 preliminary month-to-month doses, with follow-up deliberate by way of week 64.

QUASAR is being operationalized by Bayer beneath a collaboration settlement with Regeneron.

(*8*)About Retinal Vein Occlusion
RVO is a standard explanation for imaginative and prescient loss in adults and the second commonest retinal vascular illness. RVO happens when there’s a blockage in a vein in the retina, which results in a buildup of blood, restricted blood circulation, elevated strain and typically ache in the attention. RVO could trigger sudden blurry imaginative and prescient or imaginative and prescient loss and might finally outcome in severe problems like swelling in the attention known as macular edema.

A protein known as vascular endothelial progress issue (VEGF) is instrumental in inflicting the vascular leakage that results in macular edema. When a vein in the retina is blocked, the degrees of VEGF enhance, which spurs new blood vessel progress. An excessive amount of VEGF can result in the formation of irregular blood vessels and should trigger imaginative and prescient to change into blurry. Anti-VEGF injections are generally used to deal with macular edema as a consequence of RVO.

There are two fundamental sorts of RVO: central retinal vein occlusion (CRVO) and department retinal vein occlusion (BRVO). In CRVO, the buildup happens in the attention’s central retinal vein and in BRVO, the buildup happens in one of many smaller department veins. Globally, RVO impacts over 28 million individuals.

(*8*)IMPORTANT SAFETY INFORMATION AND INDICATIONS

(*8*)INDICATIONS
EYLEA HD^® (aflibercept) Injection 8 mg is a prescription drugs permitted for the remedy of sufferers with Moist Age-Associated Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

EYLEA® (aflibercept) Injection 2 mg is a prescription drugs permitted for the remedy of sufferers with Moist Age-Associated 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).

(*8*)IMPORTANT SAFETY INFORMATION

• EYLEA HD and EYLEA are administered by injection into the attention. You shouldn’t use EYLEA HD or EYLEA when you’ve got an an infection in or across the eye, eye ache or redness, or recognized allergic reactions to any of the elements in EYLEA HD or EYLEA, together with aflibercept.
• Injections into the attention with EYLEA HD or EYLEA may result in an an infection in the attention, retinal detachment (separation of retina from again of the attention) and, extra hardly ever, severe irritation of blood vessels in the retina that will embrace blockage. Name your physician immediately for those who or your child (if being handled with EYLEA for Retinopathy of Prematurity) expertise eye ache or redness, gentle sensitivity, or a change in imaginative and prescient after an injection.
• In some sufferers, injections with EYLEA HD or EYLEA could trigger a brief enhance in eye strain inside 1 hour of the injection. Sustained will increase in eye strain have been reported with repeated injections, and your physician could monitor this after every injection.
• In infants with Retinopathy of Prematurity (ROP), remedy with EYLEA will want prolonged intervals of ROP monitoring.
• There’s a potential however uncommon threat of great and typically deadly unwanted side effects, associated to blood clots, resulting in coronary heart assault or stroke in sufferers receiving EYLEA HD or EYLEA.
• The most typical unwanted side effects reported in sufferers receiving EYLEA HD had been cataract, elevated redness in the attention, elevated strain in the attention, eye discomfort, ache, or irritation, blurred imaginative and prescient, vitreous (gel-like substance) floaters, vitreous detachment, harm to the outer layer of the attention, and bleeding in the again of the attention.
• The most typical unwanted side effects reported in sufferers receiving EYLEA had been elevated redness in the attention, eye ache, cataract, vitreous detachment, vitreous floaters, transferring spots in the visual view, and elevated strain in the attention.
• The most typical unwanted side effects reported in pre-term infants with ROP receiving EYLEA had been separation of the retina from the again of the attention, elevated redness in the attention, and elevated strain in the attention. Unwanted side effects that occurred in adults are thought-about relevant to pre-term infants with ROP, although not all had been seen in medical research.
• Chances are you’ll expertise momentary visible adjustments after an EYLEA HD or EYLEA injection and related eye exams; don’t drive or use equipment till your imaginative and prescient recovers sufficiently.
• For extra security info, please discuss to your physician and see the total Prescribing Data for EYLEA HD and EYLEA.

(*8*)You’re inspired to report damaging unwanted side effects of pharmaceuticals to the FDA. Go to (*8*)www.fda.gov/medwatch(*8*) or name 1-800-FDA-1088.

(*8*)Please click on right here for full Prescribing Data for (*8*)EYLEA HD(*8*) and (*8*)EYLEA(*8*).

(*8*)About Regeneron
Regeneron (NASDAQ: REGN) is a number one biotechnology firm that invents, develops and commercializes life-transforming medicines for individuals with severe illnesses. Based and led by physician-scientists, our distinctive skill to repeatedly and persistently translate science into drugs has led to quite a few permitted remedies and product candidates in growth, most of which had been homegrown in our laboratories. Our medicines and pipeline are designed to assist sufferers with eye illnesses, allergic and inflammatory illnesses, most cancers, cardiovascular and metabolic illnesses, neurological illnesses, hematologic circumstances, infectious illnesses, and uncommon illnesses.

Regeneron pushes the boundaries of scientific discovery and accelerates drug growth utilizing our proprietary applied sciences, resembling VelociSuite^®, which produces optimized absolutely human antibodies and new courses of bispecific antibodies. We’re shaping the following frontier of drugs with data-powered insights from the Regeneron Genetics Heart^® and pioneering genetic drugs platforms, enabling us to determine modern targets and complementary approaches to probably deal with or remedy illnesses.

For extra info, please go to www.Regeneron.com or observe Regeneron on LinkedIn, Instagram, Fb or X.

(*8*)Ahead-Wanting Statements and Use of Digital Media
This press launch consists of forward-looking statements that contain dangers and uncertainties regarding future occasions and the longer term efficiency of Regeneron Prescribed drugs, Inc. (“Regeneron” or the “Firm”), and precise occasions or outcomes could differ materially from these forward-looking statements. Phrases resembling “anticipate,” “anticipate,” “intend,” “plan,” “imagine,” “search,” “estimate,” variations of such phrases, and comparable expressions are meant to determine such forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. These statements concern, and these dangers and uncertainties embrace, amongst others, the character, timing, and potential success and therapeutic functions of merchandise marketed or in any other case commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Merchandise”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and analysis and medical applications now underway or deliberate, together with with out limitation EYLEA HD^® (aflibercept) Injection 8 mg; the probability, timing, and scope of potential regulatory approval and industrial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Merchandise, resembling EYLEA HD for the remedy of sufferers with macular edema following retinal vein occlusion (“RVO”); uncertainty of the utilization, market acceptance, and industrial success of Regeneron’s Merchandise and Regeneron’s Product Candidates and the influence of research (whether or not carried out by Regeneron or others and whether or not mandated or voluntary), together with the research mentioned or referenced in this press launch, on any of the foregoing or any potential regulatory approval of Regeneron’s Merchandise (resembling EYLEA HD for the remedy of sufferers with RVO) and Regeneron’s Product Candidates; the power of Regeneron’s collaborators, licensees, suppliers, or different third events (as relevant) to carry out manufacturing, filling, ending, packaging, labeling, distribution, and different steps associated to Regeneron’s Merchandise and Regeneron’s Product Candidates; the power of Regeneron to handle provide chains for a number of merchandise and product candidates; questions of safety ensuing from the administration of Regeneron’s Merchandise (resembling EYLEA HD) and Regeneron’s Product Candidates in sufferers, together with severe problems or unwanted side effects in connection with using Regeneron’s Merchandise and Regeneron’s Product Candidates in medical trials; determinations by regulatory and administrative governmental authorities which can delay or prohibit Regeneron’s skill to proceed to develop or commercialize Regeneron’s Merchandise and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Merchandise, analysis and medical applications, and enterprise, together with these regarding affected person privateness; the supply and extent of reimbursement of Regeneron’s Merchandise from third-party payers, together with personal payer healthcare and insurance coverage applications, well being upkeep organizations, pharmacy profit administration corporations, and authorities applications resembling Medicare and Medicaid; protection and reimbursement determinations by such payers and new insurance policies and procedures adopted by such payers; adjustments in legal guidelines, rules, and insurance policies affecting the healthcare trade; competing medicine and product candidates which may be superior to, or less expensive than, Regeneron’s Merchandise and Regeneron’s Product Candidates (together with biosimilar variations of Regeneron’s Merchandise); the extent to which the outcomes from the analysis and growth applications carried out by Regeneron and/or its collaborators or licensees could also be replicated in different research and/or result in development of product candidates to medical trials, therapeutic functions, or regulatory approval; unanticipated bills; the prices of growing, producing, and promoting merchandise; the power of Regeneron to satisfy any of its monetary projections or steerage and adjustments to the assumptions underlying these projections or steerage; the potential for any license, collaboration, or provide settlement, together with Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated corporations, as relevant), to be cancelled or terminated; the influence of public well being outbreaks, epidemics, or pandemics on Regeneron’s enterprise; and dangers related with litigation and different proceedings and authorities investigations regarding the Firm and/or its operations (together with the pending civil proceedings initiated or joined by the U.S. Division of Justice and the U.S. Legal professional’s Workplace for the District of Massachusetts), dangers related with mental property of different events and pending or future litigation relating thereto (together with with out limitation the patent litigation and different associated proceedings regarding EYLEA^® (aflibercept) Injection 2 mg), the last word consequence of any such proceedings and investigations, and the influence any of the foregoing could have on Regeneron’s enterprise, prospects, working outcomes, and monetary situation. A extra full description of those and different materials dangers could be discovered in Regeneron’s filings with the U.S. Securities and Trade Fee, together with its Type 10-Ok for the yr ended December 31, 2024. Any forward-looking statements are made based mostly on administration’s present beliefs and judgment, and the reader is cautioned to not depend on any forward-looking statements made by Regeneron. Regeneron doesn’t undertake any obligation to replace (publicly or in any other case) any forward-looking assertion, together with with out limitation any monetary projection or steerage, whether or not because of new info, future occasions, or in any other case.

Regeneron makes use of its media and investor relations web site and social media retailers to publish essential details about the Firm, together with info which may be deemed materials to traders. Monetary and different details about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations web site (https://investor.regeneron.com) and its LinkedIn web page (https://www.linkedin.com/firm/regeneron-pharmaceuticals).

(*3*)