Kodiak shares more than double after two macular degeneration drugs succeed in trials

Kodiak Sciences shares more than doubled on the 28th (local time) after news that two macular degeneration drugs succeeded in phase 3 trials comparing them with Regeneron’s Eylea.

According to BioPharmaDive, Kodiak said that its eye disease treatments Zenkuda and tavirapusp alfa tedromer demonstrated noninferiority to Eylea in phase 3 trials for wet age-related macular degeneration. The news added more than $3 billion (about 4 trillion won) to Kodiak’s market capitalization.

Kodiak said Zenkuda delivered vision improvements equivalent to Eylea’s through an individualized dosing strategy. Fifty-four percent of trial participants received an injection only once every 6 months, while Eylea must be administered every 8 weeks.

The second drug, tavirapusp alfa tedromer, also showed efficacy equivalent to Eylea with an individualized dosing strategy.

In terms of efficacy, Zenkuda improved vision test scores by an average of 7.2 letters, similar to Eylea’s 7.6 letters. It was also noninferior on measures of retinal dryness. The number of adverse events was similar for the two drugs, including major adverse events such as retinal hemorrhage and cataracts.

Tavirapusp alfa tedromer improved vision test scores by 6.3 letters, and its scores for ocular dryness and number of adverse events were also similar.

Charles Wykoff, an ophthalmology professor at the Blanton Eye Institute at Houston Methodist Hospital, said in a statement provided by Kodiak, “The Zenkuda results exceeded expectations” and “provided the clinical profile that retina specialists are looking for.”

The results marked a turning point for Kodiak and Zenkuda. In a trial announced more than 4 years ago, Zenkuda had fallen short of Eylea. Kodiak said at the time that the failure was due to participants who needed more frequent dosing.

For the design of this phase 3 trial, Kodiak used a tool to check for fluid buildup in participants’ eyes and determine whether additional injections were needed.

Kodiak plans to submit Zenkuda for approval to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year. The submission will cover wet age-related macular degeneration, which was treated in this trial, and two other eye diseases. The company plans to submit tavirapusp alfa tedromer for approval by the end of next year.