Xdemvy Shortage: What Providers and Prescribers Need to Know in 2026

Xdemvy (Lotilaner ophthalmic solution 0.25%) has become a cornerstone treatment for Demodex blepharitis since its FDA approval in August 2023. As the only approved prescription therapy targeting Demodex mites directly, it's filling a significant gap in ophthalmic care. However, many eye care providers are fielding questions from patients who can't seem to find Xdemvy at their local pharmacy.

This briefing covers the current availability picture, prescribing considerations, cost and access information, and practical tools to help your patients get started on treatment.

Timeline: From Approval to Present

Understanding the trajectory of Xdemvy's rollout helps contextualize today's availability:

• August 2023: FDA approves Xdemvy (Lotilaner ophthalmic solution 0.25%) for the treatment of Demodex blepharitis — the first and only medication approved for this indication
• Late 2023: Commercial launch through limited distribution specialty pharmacy network
• 2024: Commercial insurance coverage begins expanding; Tarsus reports growing payer coverage across major plans
• 2025: Medicare Part D coverage becomes available; insurance access reaches approximately 85% of insured patients
• 2026: Coverage continues to expand across commercial, Medicare Part D, and Medicaid. Majority of insured patients pay $30 or less with coverage and available savings

Prescribing Implications

Distribution Model

Xdemvy is classified as a limited distribution drug (LDD). It is not stocked at retail pharmacies. Prescriptions must be routed to one of the approved specialty pharmacies in the Xdemvy distribution network, including:

• CVS Specialty
• Walgreens Specialty
• Other approved specialty pharmacy partners

Providers should e-prescribe Xdemvy directly to one of these specialty pharmacies. A prescription form is available on the Xdemvy HCP website for offices that prefer fax-based ordering.

Dosing and Treatment Course

The approved dosing is straightforward:

• Dose: One drop in each affected eye, twice daily (approximately 12 hours apart)
• Duration: 6 weeks (42 days)
• Rationale: The 42-day course covers at least two full Demodex mite life cycles

No dose adjustments are required for special populations. The systemic exposure from ophthalmic administration is minimal — approximately 0.005 mg/kg/day, well below preclinical safety thresholds.

Safety Profile

Clinical trial data demonstrate a favorable safety profile:

• Most common adverse reactions: Instillation site stinging (10%) and burning (10%)
• Less common (<2%): Chalazion/hordeolum, punctate keratitis
• No boxed warning
• No known drug interactions: Lotilaner is not expected to interact with systemic medications
• No contraindications listed in the prescribing information

For patients who report stinging or burning, counseling on the transient nature of these effects (typically lasting less than a minute) can improve adherence. For more on side effects, see our patient-facing side effects guide, which you can share with patients.

Current Availability Picture

Despite patient reports of difficulty finding Xdemvy, the medication is not on the FDA drug shortage list as of March 2026. Availability challenges stem from the limited distribution model rather than manufacturing supply issues.

Key points for your practice:

• Xdemvy is available and shipping from specialty pharmacies nationwide
• Home delivery is standard, with most patients receiving medication within 3-5 business days
• In-store pickup at CVS or Walgreens retail locations may be available through their specialty divisions
• If a patient reports difficulty, the most common cause is that the prescription was sent to a non-participating pharmacy or that prior authorization is pending

Cost and Access

Pricing

• Wholesale/cash price: Approximately $1,850 for a full 6-week course (10 mL)
• Individual bottle: 5 mL for approximately $600
• With insurance and savings: Majority of patients pay $30 or less

Insurance Coverage

Tarsus Pharmaceuticals reports that insurance coverage of Xdemvy has reached over 85% of insured patients across:

• Commercial insurance plans
• Medicare Part D
• Medicaid

Prior authorization is required by most plans. The specialty pharmacy typically initiates this process and can use CoverMyMeds to streamline approvals. Including the following on the prescription can expedite PA processing:

• Patient date of birth
• Contact phone number
• Prescription plan name and pharmacy member ID
• Clinical documentation of Demodex blepharitis diagnosis (ICD-10: H01.00 or B88.0)

Savings Programs

• Xdemvy Savings Card: Eligible commercially insured patients may pay as little as $0. The specialty pharmacy can help patients determine eligibility at the point of dispensing.
• Tarsus Connect Patient Assistance Program: For uninsured or underinsured patients who meet financial hardship criteria. Enrollment requires a provider-completed form.
• Tarsus Field Reimbursement Managers: Available to support your office staff with insurance navigation, prior authorization support, and savings solutions. Contact information is available on the Xdemvy HCP website.

Tools and Resources for Your Practice

Several tools can help you and your patients navigate Xdemvy access:

• Medfinder for Providers: Check pharmacy availability and help patients locate Xdemvy in stock. Our provider dashboard offers real-time data across pharmacy networks.
• Xdemvy HCP website (xdemvyhcp.com): Prescribing guides, office workflow resources, prescription forms, and reimbursement support contacts
• CoverMyMeds: Integrated prior authorization processing through participating specialty pharmacies

Consider developing a standard workflow for Xdemvy prescriptions in your practice. Key steps:

1. Diagnose Demodex blepharitis (slit lamp exam, collarettes, cylindrical dandruff at lash base)
2. Prescribe Xdemvy via e-prescribe to an approved specialty pharmacy
3. Include all required patient information for insurance processing
4. Inform the patient that a specialty pharmacy will contact them within 1-2 business days
5. Provide the patient with information about savings programs

Looking Ahead

The Demodex blepharitis treatment landscape continues to evolve. As screening awareness increases, diagnosis rates are rising — with an estimated 25 million Americans affected, many patients in your practice may benefit from evaluation. Insurance coverage for Xdemvy is expanding, and the specialty pharmacy process has become more efficient since the drug's 2023 launch.

For patients who cannot access Xdemvy, evidence-based alternatives include tea tree oil lid scrubs (Terpinen-4-ol), oral or topical Ivermectin, BlephEx microblepharoexfoliation, and IPL therapy. However, Xdemvy remains the only treatment with FDA approval and Level 1 clinical trial evidence for this indication.

Final Thoughts

Xdemvy represents a significant advance in Demodex blepharitis management. While the limited distribution model creates workflow differences from typical ophthalmic prescriptions, the infrastructure is now well-established. With proper routing to specialty pharmacies, proactive prior authorization, and patient education about the process, most patients can begin treatment within a week of diagnosis.

For more resources:

• Medfinder Provider Tools
• How to Help Your Patients Find Xdemvy in Stock: A Provider's Guide
• How to Help Patients Save Money on Xdemvy