Regeneron Pharmaceuticals REGN announced that it has met the primary endpoint in a late-stage study evaluating Eylea HD (aflibercept) Injection 8 mg to treat patients with macular edema following retinal vein occlusion (RVO). The intended patient population includes those with central, branch and hemiretinal vein occlusions.

Eylea is Regeneron’s blockbuster eye disease drug, which is already approved for wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy and RVO.The FDA has also approved Eylea to treat preterm infants with retinopathy of prematurity as well. Eylea HD is a high-dose version of Eylea.

REGN’s EYLEA HD Improves Vision in RVO Patients

Regeneron’s phase III QUASAR study evaluated the efficacy and safety of Eylea HD in patients with RVO compared with the current standard of care, Eylea. Data showed that patients treated with Eylea HD every eight weeks (after three or five initial monthly doses) achieved non-inferior vision gains, measured using best corrected visual acuity improvement, compared to those treated with the approved monthly dosing regimen of Eylea at week 36. Eylea HD results were consistent across patients with branch RVOs and those with central retinal or hemiretinal vein occlusions.

In the past three months, shares of REGN have plunged 35.7% compared with the industry’s 10.8% decline.

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According to Regeneron, all FDA-approved anti-VEGF therapies for the RVO indication currently require monthly dosing, which is a burden for many patients. The promising results from the QUASAR study demonstrate that Eylea HD can enhance vision in RVO patients while requiring fewer injections compared to Eylea. This marks a significant advancement in treatment, improving patients' quality of life and potentially boosting compliance rates.

Additionally, about 90% of Eylea HD patients were able to maintain eight-week dosing intervals through the 36-week treatment period. In the QUASAR study, Eylea HD demonstrated a safety profile comparable to that of Eylea. Additionally, it aligned with the established safety profile of Eylea HD observed in previous pivotal studies.

REGN’s Next Steps

Regeneron is currently gearing up to submit the phase III QUASAR study results to regulatory bodies around the world. A regulatory filing in the United States is anticipated in the first quarter of 2025. The regulatory submission will seek a label expansion for Eylea HD to treat RVO. The safety and efficacy of EYLEA HD for treating RVO is yet to be evaluated by any regulatory body.

Detailed results from the late-stage study of Eylea HD for RVO will be presented at a later medical conference.

Please note that Bayer’s BAYRY HealthCare unit co-develops Eylea with Regeneron. REGN records net product sales of Eylea in the United States. Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.

Regeneron Pharmaceuticals, Inc. Price and Consensus

Regeneron Pharmaceuticals, Inc. price-consensus-chart | Regeneron Pharmaceuticals, Inc. Quote

REGN’s Zacks Rank & Stocks to Consider

Regeneron currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Castle Biosciences CSTL and Spero Therapeutics SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, 2024 estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In the past three months, shares of Castle Biosciences have lost 7.8%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In the past three months, Spero’s shares have lost 23.6%.

SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.

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