Regeneron announces the US FDA approval of new drug for the treatment of Wet AMD, DME, and Diabetic Retinopathy

US Food and Drug Administration (FDA) has approved Eylea HD (aflibercept) Injection 8 mg, which will be used to treat patients suffering from wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), announced Regeneron Pharmaceuticals, Inc. today.

The dose for Eylea HD has been recommended as 8 mg (0.07 mL of 114.3 mg/mL solution) every 4 weeks (monthly) for the first 3 months against all the indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for diabetic retinopathy (DR).

“The FDA approval of Eylea HD is an important advancement in retinal care,” said Peter Kaiser, M.D., Chaney Family Endowed Chair in Ophthalmology Research at the Cole Eye Institute and Professor of Ophthalmology at Cleveland Clinic Lerner College of Medicine. “With Eylea HD, patients with wet age-related macular degeneration or diabetic retinal disease can now receive less frequent injections after their initial monthly doses and still experience the similar visual gains, anatomic improvements and safety profile of Eylea.”

“I look forward to offering Eylea HD to my patients as a new treatment option that builds off of the established efficacy and safety profile of Eylea,” said Allen C. Ho M.D., director of Retina Research and co-director of the Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. “In its clinical trial programme, Eylea HD demonstrated an unprecedented ability to maintain vision with extended dosing intervals, which created an exciting new advancement in the treatment of our patients with serious retinal diseases.”

The approval is based on the result of two double masked, active controlled pivotal trials analysing the Eylea HD in comparison to Eylea (Aflibercept) injection 2 mg. The trials lasted 48 weeks, named PULSAR and PHOTON, were conducted globally in several centres. The major sponsors for PULSAR and PHOTON were Bayer and Regeneron, respectively. Both the trials exhibited non-inferior and clinically equivalent vision improvement at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses, compared to an Eylea 8-week dosing regimen after initial monthly doses (3 in PULSAR and 5 in PHOTON). Most of the patients who were chosen randomly at the end of Eylea HD 12- or 16-week dosing regimens (following 3 initial monthly doses) were able to maintain the dosing breaks through 48 weeks.

The alleged most common (3%) adverse reaction in patients who were treated with Eylea HD included cataract, vitreous floaters, conjunctival haemorrhage, increased intraocular pressure, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous detachment, corneal epithelium defect, and retinal haemorrhage.

“More than 10 years ago, we fundamentally changed the way that certain serious retinal diseases were treated with the introduction of Eylea. With the approval of Eylea HD, we have elevated the high standard that Eylea set,” said George D. Yancopoulos, M.D., Ph.D., board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of Eylea. “Our continued commitment to retinal diseases resulted in an important scientific innovation – evolving the proven efficacy and safety of Eylea into a new treatment, Eylea HD, that provides lasting vision control with even fewer injections to further benefit those living with wet age-related macular degeneration or diabetic retinal diseases."

Regeneron has strong commitments towards helping patients with Eylea HD prescriptions against their medical conditions in order to make it accessible for them. Eylea also has a patient assistance and financial cost support called Eylea 4U which is committed towards assisting their patients in processing the importance of a health insurance and how the cost of Eylea HD may also be covered under their health insurance plans. Eylea HD also provides additional financial assistance for eligible patients only against Eylea HD prescriptions.

The development of Eylea HD is being done under the supervision and name of Regeneron and Bayer AG simultaneously. The licensing for Eylea and Eylea HD in United States is under Regeneron however, exclusive marketing rights outside of the US are licensed under Bayer AG. The profits coming from the sales of both Eylea and Eylea HD are shared between both the companies following regulatory approvals. The regulatory filing for Eylea HD (aflibercept) 8mg are under review in Europe and Japan. It has also been planned to submit the regulatory filings to other countries as well.

Cutting-edge research that took place about a decade ago resulted in the development of Eylea a vascular endothelial growth factor (VEGF) inhibitor, has been playing a vital role ever since in the retinal disease treatment landscape. With Eylea HD, Regeneron has proved that it has been consistently advancing the anti-angiogenesis expertise with new solutions with the target of providing optimal flexibility for patients as well as eye care professionals.