Kalaris Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Kalaris Therapeutics (KLRS).
Over the past two years, Kalaris Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TH103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TH103 FDA Regulatory Timeline and Events
TH103 is a drug developed by Kalaris Therapeutics for the following indication: in Neovascular Age-Related Macular Degeneration.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TH103
- Announced Date:
- January 28, 2026
- Indication:
- in Neovascular Age-Related Macular Degeneration
Announcement
Kalaris Therapeutics, Inc. announced that clinical data from its Phase 1 study of TH103 will be presented at the 49th Annual Meeting of the Macula Society, taking place February 25-28 in San Diego, California.
AI Summary
Kalaris Therapeutics announced that clinical data from its Phase 1 study of TH103 will be presented at the 49th Annual Meeting of the Macula Society, taking place February 25–28 in San Diego, California. The company said the presentation will share early clinical findings for TH103, a candidate therapy aimed at treating retinal disease.
The Macula Society meeting is a highly selective, invitation-only forum where internationally recognized retinal specialists gather to present and critically evaluate emerging clinical data and novel treatment strategies for macular and retinal vascular diseases. Attendance and peer discussion at this meeting can help shape the scientific and clinical view of new retinal therapies.
Kalaris is a clinical-stage biopharmaceutical company focused on developing and commercializing treatments for common, sight‑threatening retinal conditions. The company was founded by Dr. Napoleone Ferrara and is committed to advancing novel therapeutic approaches for patients with major unmet needs.Read Announcement
- Drug:
- TH103
- Announced Date:
- December 17, 2025
- Indication:
- in Neovascular Age-Related Macular Degeneration
Announcement
Kalaris Therapeutics, Inc announced positive initial data from its Phase 1a single ascending dose (SAD) trial of TH103, a fully humanized, recombinant fusion protein that acts against VEGF as a decoy receptor, in treatment-naïve patients with neovascular age-related macular degeneration (nAMD).
AI Summary
Kalaris Therapeutics reported positive initial Phase 1a single ascending dose results for TH103, a fully humanized recombinant fusion protein that acts as a VEGF decoy receptor in treatment‑naïve neovascular AMD patients. In 13 patients followed for six months, a single intravitreal injection (0.5–2.5 mg) produced a mean 10‑letter gain in best corrected visual acuity at Month 1, a mean 129 µm reduction in central subfield thickness, and about a 95% drop in central intraretinal fluid. TH103 was generally well tolerated: no dose‑limiting toxicities or TH103‑related serious adverse events were observed. Two transient, mild–moderate intraocular inflammations at the 2.5 mg dose were attributed to host cell protein and were addressed by improved purification; no new cases occurred after the change.
Pharmacokinetics showed dose‑adjusted plasma Cmax 27–51‑fold lower than current leading agents, consistent with greater intraocular retention and lower systemic exposure. After one dose, 31% of patients needed no further anti‑VEGF therapy over six months. Kalaris plans further dose escalation and is accelerating its Phase 1b/2 multi‑ascending dose study, with preliminary data expected in H2 2026.
Read Announcement- Drug:
- TH103
- Announced Date:
- September 15, 2025
- Indication:
- in Neovascular Age-Related Macular Degeneration
Announcement
Kalaris Therapeutics, Inc. announced that it is now enrolling a Phase 1b/2 multiple ascending dose (MAD) study of TH103 in patients with neovascular age-related macular degeneration (nAMD).
AI Summary
Kalaris Therapeutics, a clinical-stage biopharmaceutical company focused on retinal diseases, has started enrolling patients in a Phase 1b/2 multiple ascending dose (MAD) study of its investigational drug TH103 for neovascular age-related macular degeneration (nAMD). This study builds on an earlier single ascending dose trial and marks a key step toward possible Phase 3 development.
In the MAD study, up to 80 nAMD patients will receive as many as four monthly injections of TH103 directly into the eye. Researchers will track safety and early signs of benefit, such as changes in vision and retinal structure. The main analysis will occur one month after the last injection, and patients will continue in an extension phase to assess longer-term effects.
Data from this dose-finding trial will help choose the best dose for future tests, with initial results expected in the second half of 2026. The ongoing Phase 1a study remains on track to report data in late 2025.
Read Announcement
Kalaris Therapeutics FDA Events - Frequently Asked Questions
As of now, Kalaris Therapeutics (KLRS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Kalaris Therapeutics (KLRS) has reported FDA regulatory activity for TH103.
The most recent FDA-related event for Kalaris Therapeutics occurred on January 28, 2026, involving TH103. The update was categorized as "Clinical Data," with the company reporting: "Kalaris Therapeutics, Inc. announced that clinical data from its Phase 1 study of TH103 will be presented at the 49th Annual Meeting of the Macula Society, taking place February 25-28 in San Diego, California."
Currently, Kalaris Therapeutics has one therapy (TH103) targeting the following condition: in Neovascular Age-Related Macular Degeneration.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:KLRS last updated on 1/28/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
