Dry eye disease is a multifactorial ocular surface disease characterized by tear-film and ocular-surface homeostasis loss, often accompanied by tear instability, hyperosmolarity, and inflammation. Patients commonly report dryness, burning, irritation, and fluctuating vision symptoms. It is a chronic condition with variable severity.
The FDA issued a complete response letter rejecting Aldeyra Therapeutics' reproxalap for dry eye disease, marking the third rejection in three years due to inconsistent trial results and lack of substantial evidence of efficacy.
Ocular Therapeutix's Axpaxli outperformed low-dose Eylea in a Phase 3 trial for wet AMD, while Oculis Holding reported narrowed Q4 losses and expects Phase 3 trial readouts for OCS-01 in Q2 2026.
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
The FDA is set to make approval decisions on five drug applications in March 2026, including treatments for psoriatic arthritis, dry eye disease, hypothalamic obesity, cholestatic pruritus, and a rare genetic disorder.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07540884 |
Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops |
NOT_YET_RECRUITING | NA |
| NCT07469865 |
Efficacy and Safety of 20% and 100% Autologous Serum Eye Drops in Patients With Severe Dry Eye Disease (AST) |
COMPLETED | NA |
| NCT07457021 |
A Study to Evaluate the Safety and Effectiveness of Perfluorohexyloctane Eye Drops on Treatment of Dry Eye Disease (DED) Related to Meibomian Gland Dysfunction (MGD) |
NOT_YET_RECRUITING | |
| NCT07363824 |
A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease. |
RECRUITING | |
| NCT07284381 |
A Clinical Study to Evaluate the Effect and Side Effect of a New Artificial Tear Formulation (ABBV-444) Compared to Refresh Optive Unit Dose in Adult Participants With Dry Eye Disease |
RECRUITING | PHASE3 |
| NCT07264517 |
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED). |
RECRUITING | PHASE2 |
| NCT07238699 |
An Evaluation of the Safety and Tolerability of Ocular Lubricants |
RECRUITING | NA |
| NCT07171710 |
Efficacy of 0.05% Cyclosporine A Eye Drops Combined With Absorbable Tear Duct Plugs in the Treatment of Dry Eye in Sjögren's Syndrom |
ENROLLING_BY_INVITATION | NA |
| NCT07140380 |
Phase 2b Controlled Study |
COMPLETED | PHASE2 |
| NCT07128628 |
A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease |
RECRUITING | PHASE2 |
