AFLIBERCEPT 8 MG BLA FOR TREATMENT OF WET AGE-RELATED MACULAR DEGENERATION AND DIABETIC MACULAR EDEMA ACCEPTED FOR FDA PRIORITY REVIEW
BLA supported by two pivotal trials demonstrating non-inferior vision gains to EYLEA® (aflibercept) Injection, with vast majority of patients maintaining extended dosing regimens through 48 weeks
If approved, aflibercept 8 mg will be second ophthalmology medicine developed by Regeneron
TARRYTOWN, N.Y., Feb. 23, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg for treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy. The FDA target action date is June 27, 2023 following the use of a priority review voucher.
The BLA is supported by positive data from two pivotal trials – PULSAR in wAMD and PHOTON in DME – that were previously presented at the 55th Annual Scientific Session of The Retina Society in November 2022. In both trials, patients treated with aflibercept 8 mg (PULSAR n=673; PHOTON n=491) met the primary endpoint of non-inferiority in vision gains for both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks compared to patients treated with an EYLEA® (aflibercept) Injection (PULSAR n=336; PHOTON n=167) 8-week dosing regimen. Additionally, the vast majority of patients randomized to aflibercept 8 mg in both trials were able to maintain the 12- and 16-week dosing regimens to which they were respectively initiated through 48 weeks (wAMD: 79% and 77%; DME: 91% and 89%). The safety profile for aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials. Comparing aflibercept 8 mg to EYLEA, ocular adverse events occurred in 31% (n=491) versus 28% (n=167) in PHOTON and 38% (n=673) versus 39% (n=336) in PULSAR, and there were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in either trial.
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 is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.
About the Aflibercept 8 mg Trial Program
PHOTON 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 wAMD
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.
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 INDICATIONS
EYLEA (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).
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.
- Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment.
- The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
- In pre-term infants with ROP receiving EYLEA the most common adverse reactions (≥4%) reported were retinal detachment, conjunctival hemorrhage, and intraocular pressure increased. Adverse reactions established for adult indications are considered applicable to pre-term infants with ROP, though not all were observed in the clinical studies.
- Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 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.
The Macular Degeneration Association and MacuHealth Announce Partnership
BIRMINGHAM, Michigan, March 07, 2023 – The Macular Degeneration Association, an organization dedicated to educating age-related macular degeneration (AMD) patients and their caregivers so they can live fuller and more comfortable lives, announced today an exclusive multi-year partnership with MacuHealth, the leader in the field of innovative eye supplements.
This partnership occurs when AMD awareness is increasing among the general population and the eye supplement market is rapidly growing. However, patients are finding it increasingly difficult to find high-quality, natural solutions that are scientifically proven to manage and prevent the disease’s symptoms.
“Education is an important key to living with and reducing the risk for AMD. In addition to regular eye exams by eyecare professionals, high-quality eye supplements go a long way to reducing the most serious vision loss to AMD. That is the principal reason I chose to partner with Macuhealth,” said Larry Hoffheimer, Chairman and Founder of the Macular Degeneration Association.
MacuHealth’s scientifically researched Triple Carotenoid Formula, which features Lutein, Zeaxanthin and Meso-Zeaxanthin formulated in a 10:10:2 ratio, is proven to increase macular pigment, which is one of the reasons why Hoffheimer and the Association’s Medical Director, Jeffry Gerson, OD, FAAO, chose it as the sole supplement provided to the Association’s network of followers and doctors.
“I am thrilled to enter this partnership with a leading education association that has relentlessly put in the work of educating patients and eye care professionals on how to manage and reduce the impact of AMD and live a full life,” said Frederic Jouhet, Founder and CEO of MacuHealth. “Lawrence Hoffheimer and Dr. Gerson brought forth a brilliant program that we are happy to support by offering their audience the best solution for people suffering from and at risk for AMD.”
To learn more about the Macular Degeneration Foundation, please visit MacularHope.org.
MacuHealth is a leader in the eye supplement industry that is focused on innovation and providing premium products formulated with the purest, most stable ingredients proven to nourish and care for the whole eye at every stage of life. MacuHealth’s products must meet the highest standards in scientific research to ensure each supplement is safe and effective. For more information, visit MacuHealth.com.
For more information, contact:
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We are pleased to announce the retina and optometric practices awarded the distinction of
AMD Centers of Excellence!
Allisonville Eye Care (Fishers, IN)
Belle Vue Specialty Eye Care (Hattiesburg, MS)
Brown Retina Institute (San Antonio, TX)
Carolina Eye Associates, P.A (North & South Carolina)
Chous Eyecare Associates (University Park, WA)
Developmental Vision Center (Oswego, IL)
Dr. Dorothy L. Hitchmoth, PLLC (New London, NH)
Eye Associates of Boca Raton, P.A. (Boca Raton, FL)
Fresno S Street Health Center (Fresno, CA)
Grin Eye Care (Leawood, KS)
In Focus Eyecare (Sarnia, Ontario)
Integrative Vision (Shrewsbury, NJ)
Island Retina (Shirley, NY)
Joseph R. Podhorzer, MD, PLLC (Brooklyn, NY)
Lipski Eye Center, PC (Lewisburg, PA)
Low Vision Eye Care (Coeur d’Alene, ID)
Low Vision Optometry of New York (Garden City, NY)
Low Vision Optometry of Southern California (Mission Viejo, CA)
Low Vision Specialists of Maryland & Virginia (Timonium, MD)
Marshall EyeCare Physicians, PC (Holmdel, NJ)
Memorial Vision, PA (Houston, TX)
Ophthalmology Associates PSC (Louisville, KY)
Orange County Retina (Santa Ana, CA)
Paul Vision Institute (Wilmington, NC)
Peter E. DeGraziano, OD, PC (San Diego, CA)
Philadelphia Retina Associates (Plymouth Meeting, PA)
Premier Vision Group (Bowling Green, OH)
Professional Eye Care Center (Niles, IL)
Retina Associates of Orange County (Laguna Hills, CA)
Retina Consultants of Southern Colorado, P.C. (Colorado Springs, CO)
Retinal Consultants of Texas (San Antonio, TX & Houston, TX)
Sarasota Retina Institute (Sarasota, FL)
Schoenbart Vison Care (Garden City, NY)
Scott Eye Care Ltd. (Oswego, IL)
Southern Low Vision (Ocean Springs, MS)
The Macula Center (Clearwater, FL)
Vision Center of Lake Norman (Mooresville, NC)
Vitreo Retinal Associates (Gainesville, FL)
Wyomissing Optometric Center (Wyomissing, PA)
FDA Approves Apellis’ SYFOVRE™
FDA Approves Apellis’ SYFOVRE™, for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
Newly approved treatment for Geographic Atrophy by FDA
Geographic atrophy (GA) is the advanced form of dry age-related macular degeneration (AMD) which causes blindness in one million people in the United States and 5 million worldwide.
This is the first time that a treatment has been approved for this leading cause of blindness.
Apellis Pharmaceuticals, a global biopharmaceutical company, announced the U.S. Food & Drug Administration (FDA) has approved SYFOVRE™ (pegcetacoplan injection) for people with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of devastating central vision loss in people over 55 in developed countries. The newly approved therapy is the first ever approved by the FDA for GA. SYFOVRE slowed the growth of lesions (areas of retinal cell loss) in two Phase 3 clinical trials. In the trials, known as DERBY and OAKS, the treatment was safe and its beneficial effect increased over time. More than 12,000 injections were delivered to trial participants over 24 months.
At 24 months in the OAKS trial (637 participants), monthly injections slowed GA lesion growth by 22 percent. Injections administered every other month slowed GA lesion growth by 18 percent.
At 24 months in the DERBY trial (621 participants), monthly injections slowed lesion growth by 18 percent. Injections administered every other month slowed lesion growth by 17 percent.
SYFOVRE will be delivered through an injection into the vitreous, the soft gel in the middle of the eye, once every 25 to 60 days in an eye doctor’s office. Frequency of the injections will be at the doctor’s discretion.
Apellis is reaching out to 2,160 retinal specialists in the United States to launch the treatment in the weeks ahead. SYFOVRE is expected to be available by the beginning of March through specialty distributors and specialty pharmacies nationwide. The company expects an approval decision for SYFOVRE from the European Medicines Agency (EMA) in early 2024. A marketing application has also been submitted to Health Canada.
SYFOVRE is designed to slow the progression of GA by inhibiting C3, a protein in the complement system. While complement is part of the human immune system that wards off harmful bacteria and viruses, it can cause damage if not controlled properly. Researchers have strong evidence that an overactive complement system is involved in the death of retinal cells in AMD.
GA lesions are the regions in the retina where degeneration from dry AMD has occurred. The fovea is a small pit in the center of the retina, rich in cone photoreceptors, that provides the sharpest vision, including the ability to read and recognize faces. GA lesions often first develop outside of the fovea — these are known as extrafoveal lesions. Over time, the lesions encroach on the foveal region leading to more significant vision loss. Experts believe that targeting extrafoveal lesions with treatments before they affect the fovea may be the optimal strategy for preserving vision in people with GA. If you have geographic atrophy (GA) associated with dry AMD, consult your retinal specialist to determine if SYFOVRE is appropriate for you.
Apellis Pharmaceuticals is a corporate partner of the Macular Degeneration Association. Thank you.
PRESERVE & PROTECT YOUR VISION DONATE TODAY
Without ongoing contributions from generous donors like you, the Macular Degeneration Association would be
unable to fund Research and Education for the millions of people living with macular degeneration.
HOW TO GIVE
Phone, Mail or Online
Phone: Please call (941)893-4387 today to speak to one of our Donor Services Representatives.
Mail: Send your check or money order today payable to:
MACULAR DEGENERATION ASSOCIATION
5969 Cattleridge Boulevard, Suite 100 | Sarasota, FL 34232
Online: Please visit www.macularhope.org today and click on the Donation tab.
Stocks, Securities, Mutual Funds and IRAs
Please give serious consideration to the donation of stock and mutual fund shares as this offers numerous opportunities
to make a most gracious gift and receive tax advantages.
Wills, Bequests and Planned Gifts
Please give serious consideration to the designation of MDA in your Will, Charitable Trusts, Life Insurance, Appreciated
Securities and Real Estate as this offers preplanned giving opportunities that will serve the macular community for
years to come. Please call Lynne Henry (941)893-4389 at the Macular Degeneration Association, today, for personal
assistance in initiating this effort.
The following language has been reviewed and is deemed a legally acceptable form for including such a bequest in a will:
“I give and bequeath to the Macular Degeneration Association, 5969 Cattleridge Blvd. Suite # 100 Sarasota, FL 34232
for discretionary use in carrying out its aims and purposes, (the sum of $_____) or ( a sum equal to _______% of
the value of my gross estate at the time of my death under this will or any codicil hereto).”
The Macular Degeneration Association Federal ID number is 27-3025707
MEMORIAL AND HONOR GIVING
Honor a family member, friend or special event by donating to MDA. Pay tribute to someone you love whose life
has been impacted by macular degeneration. In lieu of flowers, please consider designating Macular Degeneration
Association as your charity of choice.
Launch a Giving Campaign
Please consider leading a team at work by encouraging your colleagues and staff to join together to help those
living with macular degeneration. Launch a workplace giving campaign today.
Ask about Matching Gifts
Many gracious employers double or even triple charitable donations made by individual employees. Some companies
will match gifts made by retirees and or their spouses. Contact your employer for matching gift eligibility
as this allows you to maximize your personal donation.