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A Second Opinion: Discussing the recent mixed results from Aurinia' Phase 2 trial in dry-eye for VOS vs. RestasisTicker(s): AUPH, AGN, TAK
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.
Please describe your clinical practice and how you currently manage DES patients.Added By: joe_mccann
What % of patients that you currently manage struggle to achieve sufficient efficacy from Restasis?
- How do you manage these patients?
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?
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?
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)
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?
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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