Kalaris Therapeutics Stock Soars on Positive Early-Stage Eye Drug Data

Shares of Kalaris Therapeutics Inc. (NASDAQ:KLRS) jumped 29% on Friday after the biotechnology company announced positive data from a Phase 1a trial of its drug candidate, TH103, for neovascular age-related macular degeneration (nAMD).

Trial Data Shows Promise

Kalaris reported that expanded cohorts in its single ascending dose trial showed improvements in vision and retinal anatomy for patients with nAMD, a leading cause of vision loss. The data, which included 20 patients who completed six months of follow-up, suggests the potential for TH103 to be a longer-lasting treatment compared to current standards.

Key findings from the company's announcement include:

• After a single injection, 29% of treatment-naive patients required no additional anti-VEGF treatment during the entire six-month follow-up period.
• 41% of treatment-naive patients received their first retreatment at four months or later.
• In treatment-experienced patients, the time to retreatment was extended by an average of two months compared to their prior anti-VEGF treatment intervals.

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Pharmacokinetic data also indicated that TH103 had 27- to 53-fold lower maximum plasma concentration (Cmax) compared to leading anti-VEGF agents, which the company stated suggests greater retention of the drug within the eye.

Safety and Next Steps

Regarding safety, Kalaris noted no cases of intraocular inflammation were observed in six patients treated at a 2.5 mg dose using a manufacturing process with reduced impurities. One patient at a higher 5 mg dose experienced transient inflammation that resolved without lasting effects.

With these results, Kalaris is now enrolling patients in a Phase 1b/2 study to evaluate a standard four-dose loading regimen of TH103 in previously untreated patients. This next-stage trial will assess safety, tolerability, and preliminary efficacy of repeated injections. The company expects to release initial data from this study in the first half of 2027.