FDA Events for KALA BIO (KALA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by KALA BIO (KALA).
Over the past two years, KALA BIO has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KPI-012. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
KPI-012 - FDA Regulatory Timeline and Events
KPI-012 is a drug developed by KALA BIO for the following indication: Clinical diagnosis of PCED.
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:
- KPI-012
- Announced Date:
- July 9, 2025
- Indication:
- Clinical diagnosis of PCED
Announcement
KALA BIO, Inc. announced the completion of patient enrollment in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for the treatment of persistent corneal epithelial defect (PCED).
AI Summary
KALA BIO, Inc. announced that patient enrollment is now complete for its CHASE Phase 2b clinical trial. This study is testing KPI-012, a human mesenchymal stem cell secretome therapy, as a new treatment for persistent corneal epithelial defect (PCED). The multicenter, randomized, double-masked, vehicle-controlled trial will compare two doses of KPI-012 with a vehicle treatment, enrolling patients from 37 sites in the United States and Latin America.
The primary goal is to assess safety and effectiveness by measuring complete healing of PCED through corneal fluorescein staining. Topline results are expected by the end of Q3 2025. If the outcomes are positive, this trial could be pivotal in supporting a Biologics License Application submission to the U.S. Food and Drug Administration, offering a much-needed treatment option for the approximately 100,000 U.S. patients with PCED.
Read Announcement- Drug:
- KPI-012
- Announced Date:
- July 9, 2025
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 - 2025
- Indication:
- Clinical diagnosis of PCED
Announcement
KALA BIO, Inc. announced that Topline results from the CHASE trial expected by end of Q3 2025 --
AI Summary
KALA BIO, Inc. recently announced that it has completed patient enrollment in its CHASE Phase 2b clinical trial, which is testing KPI-012 for treating persistent corneal epithelial defect (PCED). The company expects to report topline data by the end of the third quarter of 2025. These results are critical because, if positive, the trial could become a pivotal study used to support a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The CHASE trial is conducted across multiple centers in the United States and Latin America, and it compares two doses of KPI-012 against a placebo over a 56-day period. KALA BIO aims to address the significant unmet need for an effective PCED treatment by potentially offering a product that covers all underlying causes of the condition.
Read Announcement- Drug:
- KPI-012
- Announced Date:
- July 7, 2025
- Indication:
- Clinical diagnosis of PCED
Announcement
KALA BIO, Inc. announced that the Company will host a webcast event with Key Opinion Leaders (KOLs) to discuss the potential of KPI-012 for the treatment of persistent corneal epithelial defect (PCED).
AI Summary
KALA BIO, Inc. announced it will host a webcast event on July 16, 2025, at 4:00 p.m. ET featuring Key Opinion Leaders (KOLs) in the field of ophthalmology. The event will center on the potential of KPI-012, the company’s lead product candidate, for treating persistent corneal epithelial defect (PCED), a rare condition where the cornea fails to heal properly. During the webcast, experts will discuss the challenges patients face with PCED and explore how KPI-012, derived from a mesenchymal stem cell secretome (MSC-S), could offer a new solution. Todd Bazemore, the interim CEO and President, will also review the commercial prospects and upcoming milestones of KPI-012. The presentation will include a Q&A session, allowing participants to engage directly with the specialists. Further details and registration information are available on the KALA BIO website.
Read Announcement
KALA BIO FDA Events - Frequently Asked Questions
As of now, KALA BIO (KALA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, KALA BIO (KALA) has reported FDA regulatory activity for KPI-012.
The most recent FDA-related event for KALA BIO occurred on July 9, 2025, involving KPI-012. The update was categorized as "Enrollment Completion," with the company reporting: "KALA BIO, Inc. announced the completion of patient enrollment in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for the treatment of persistent corneal epithelial defect (PCED)."
Currently, KALA BIO has one therapy (KPI-012) targeting the following condition: Clinical diagnosis of PCED.
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:KALA) was last updated on 7/11/2025 by MarketBeat.com Staff
