Dive Brief:

• Shares in eye-drug developer Kodiak Sciences more than doubled Monday after the company said its two drugs for macular degeneration succeeded in a Phase 3 clinical trial that compared them with Regeneron Pharmaceuticals’ Eylea.
• Kodiak’s Zenkuda was able to match Eylea’s eyesight improvement using an individualized dosing strategy that allowed more than half of trial participants to receive injections only once every six months compared with once every eight weeks for Eylea, Kodiak said. The biotech’s second drug, called tabirafusp alfa tedromer, also matched Eylea using an individualized dosing strategy.
• The company expects to ask the Food and Drug Administration for approval of Zenkuda in wet age-related macular degeneration, the condition treated in the trial reported Monday, along with two other eye disorders in the fourth quarter of 2026. The news marks a turnaround for Kodiak and Zenkuda, which failed to match Eylea in a trial that read out more than four years ago. Kodiak’s market value climbed by more than $3 billion.

Dive Insight:

Millions of Americans have age-related eye disorders that can be treated by drugs that block the overdevelopment of blood vessels and other inflammatory processes. That number is growing as the population ages, too. Roche’s Lucentis launched 20 years ago and was effective in arresting vision loss, but also put a burden on ophthalmologists’ offices because of the need for monthly eye injections.

Drugs that have emerged since have sought to lengthen the dosing interval while being as safe and offering similar effectiveness. Initially, Eylea reduced the dosing interval to once every eight weeks after a loading period, and a high-dose version introduced later can be injected as seldom as once every 16 to 20 weeks. A newer Roche drug called Vabysmo also can be injected once every 16 weeks.

However, Kodiak argues that these newer drugs have been falling short of their durability claims in real-world use, necessitating a newer generation of medicines that can space out shots even further.

Kodiak said its initial failure with Zenkuda was related to trial enrollees who needed more frequent doses. In designing the Phase 3 trial, the company decided to use a tool that would identify fluid buildup in enrollees’ eyes to determine whether they need another injection. Use of this tool enabled 54% of enrollees taking Zenkuda to go six months between shots, Kodiak said.

On efficacy, Zenkuda was “non-inferior” to Eylea, improving enrollees’ results on a visual acuity test by 7.2 letters on average compared to 7.6 letters for Eylea. It was also non-inferior on a measure of retinal drying. The two drugs had similar numbers of adverse events, including key side effects like retinal hemorrhage and cataracts.

“The Zenkuda results exceeded my expectations, delivering the clinical profile retina specialists are seeking: rapid vision and anatomic improvements comparable to aflibercept during loading, followed by meaningfully longer intervals between treatment for a majority of patients, while maintaining optimal fluid control,” Charles Wykoff, an ophthalmology professor at Houston Methodist Hospital’s Blanton Eye Institute, said in a statement provided by Kodiak.

The second drug, tabirafusp alfa tedromer or tabirafusp-ted, also was statistically non-inferior on efficacy, improving patient performance on the eye test by 6.3 letters and having similar ocular drying scores. It had similar numbers of adverse events as well.

Kodiak expects to ask the FDA for approval of tabirafusp-ted late next year.