8-K - Ocugen, Inc. | StockGist

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Ocugen, Inc. announced topline 12-month data from the Phase 2 ArMaDa clinical trial of OCU410 modifier gene therapy for geographic atrophy secondary to dry age-related macular degeneration, with the optimal (medium) dose showing a statistically significant 31% reduction in lesion growth versus control (lesions ≥2.5 mm² and ≤17.5 mm², N=39). The company scheduled a conference call and webcast for March 24, 2026, at 8:00 a.m. EDT to discuss the data.

Key Takeaways

1Phase 2 ArMaDa trial: medium dose 31% reduction in GA lesion growth vs control at 12 months (p-value via MMRM, lesions ≥2.5 mm² ≤17.5 mm², N=39 evaluable)

2High dose: 16% reduction in lesion growth vs control (same criteria)

3For stricter lesions ≥5 mm² ≤17.5 mm² (N=31): medium 33%, high 31% reduction vs control

4No OCU410-related SAEs or AESIs reported; all CNV unrelated per DSMB

5Optimal dose (medium) intended for Phase 3; primary analysis p-value with 95% power targeted 3Q 2026

6Conference call/webcast March 24, 2026, 8:00 a.m. EDT; presentations in Exhibits 99.2 and 99.3

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

of this Form 8-K, including Exhibits 99.1 , 99.2 and 99.3 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the

Regulation Fd

9.01

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Document 99.1 Press Release, dated March 24, 2026. 99.2 Webcast Presentation, dated March 24, 2026.

Exhibits Only

Source Document

Exhibits (4)

8-K

FORM 8-K

99.1

EXHIBIT 99.1

99.2

EXHIBIT 99.2

99.3

EXHIBIT 99.3