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Expert Interview

Slingshot members are talking to an expert! The topic is:

A Second Opinion: Discussing the recent mixed results from Aurinia' Phase 2 trial in dry-eye for VOS vs. Restasis

Ticker(s): AUPH, AGN, TAK

Who's the expert?

Name: Dr Jeffery Goshe - MD

Institution: Cleveland Clinic

  • Cornea / comprehensive practice at Cleveland Clinic with a research focus on corneal transplantation.
  • Sees 20 Dry Eye patients per week, with over 2,000 in his practice.
  • Very familiar with the VOS data, but not involved in the trial.

Interview Questions
Q1.

Please describe your clinical practice and how you currently manage DES patients.

Added By: joe_mccann
Q2.

What % of patients that you currently manage struggle to achieve sufficient efficacy from Restasis?

  • How do you manage these patients?  

Added By: joe_mccann
Q3.

The side effect endpoint looked at in the VOS Phase 2 trial is "drop discomfort at 1-minute on Day 1"

Do you think this endpoint is the best way to quantify the side effect issues with these drops? 

  • What other endpoints would be interesting? 
  • What % of your DES patients has issues with Restasis' tolerability?

Added By: joe_mccann
Q4.

Looking at the dose used in the study VOS was a .2% solution vs. Restasis at 0.05%. Given that they are both CNIs do you think this played into the efficacy difference?

  • Have you seen at any PK data to see if the doses were equivalent? 

Added By: joe_mccann
Q5.

What is your opinion of the efficacy results?  Can we walk through your thoughts on each of these data points? These results are for the patient's "worst eye"

  • 42.9% of VOS subjects vs 18.4% of Restasis® subjects (p=.0055) demonstrated ≥ 10mm improvement in STT at Week 4
  • Mean increase in STT for VOS was 8.6 at week 4 vs. 3.3 (p=0.0051)
  • Fluorescein Corneal Staining (FCS) of -2.2 for VOS vs. -0.2 for Restasis (P=0.0003)

Added By: joe_mccann
Q6.

If these results held up in a Phase 3 trial and VOS was approved on a 0.2 concentration, what % of your patients would you be likely to prescribe VOS.

  • How does generic Restasis likely change this number?

Added By: joe_mccann
Q7.

On a scale of 1-10, how excited for VOS in Dry-eye are you after these Phase 2 results?

Added By: joe_mccann

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