Kalaris Therapeutics reports positive Phase 1a TH103 data showing vision gains, reduced plasma exposure

Kalaris Therapeutics reported positive expanded Phase 1a SAD data for TH103 showing mean 9.2‑letter BCVA gain and improved retinal anatomy.

Key Highlights:

• Expanded SAD dataset: 17 treatment‑naïve and 3 treatment‑experienced patients completed 6‑month follow‑up, reinforcing prior positive findings.
• Clinical efficacy: mean 9.2‑letter BCVA improvement at Month 1; mean 118µm reduction in CST and ~93% intraretinal fluid resolution.
• Durability signal: 41% of treatment‑naïve patients retreated ≥4 months, 35% ≥5 months, and 29% required no retreatment through 6 months.
• Pharmacokinetics: TH103 showed 27–53‑fold lower plasma Cmax on molar basis versus leading anti‑VEGFs, suggesting greater intraocular retention.
• Safety and manufacturing: no IOI observed among six patients at 2.5 mg using purified batch #2; one transient IOI at 5 mg resolved without sequelae.

Original SEC Filing:

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