Factors Affecting the Price of Xiidra

Key factors influencing Xiidra's price may include:

1. R&D Investment:

Significant costs are incurred during extensive preclinical studies (animal toxicity, fertility) and large, multi-phase clinical trials (four 12-week studies involving over 1,000 patients) required for FDA approval.

2. Manufacturing Complexity:

Producing a sterile, isotonic ophthalmic solution with specific pH and osmolality controls, packaged in specialized single-use containers within protective foil pouches, adds cost.

3. Patent Protection:

As a branded drug (initial approval 2016, label revised 2020) with a novel mechanism (LFA-1 antagonist), Xiidra benefits from patent exclusivity, limiting competition.

4. Targeted Indication:

It addresses a specific chronic condition (Dry Eye Disease signs and symptoms) requiring long-term, twice-daily treatment, impacting volume and pricing strategy.

5. Post-Marketing Costs:

Ongoing safety monitoring (e.g., postmarketing adverse reaction reporting) and regulatory compliance contribute to expenses.