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Voclosporin ophthalmic solution yields positive results for dry eye
Aurinia Pharmaceuticals’ voclosporin ophthalmic solution demonstrated positive results in an exploratory phase 2 study evaluating the efficacy, safety and tolerability of the treatment for dry eye syndrome, according to a company press release.
The 100-patient, double-masked study compared voclosporin ophthalmic solution 0.2% and Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) twice daily in both eyes for 28 days.
The primary endpoint of drop discomfort at 1 minute on day 1 was not statistically significantly different between the two drugs. However, at 4 weeks, the study drug demonstrated a statistically significant improvement in Schirmer tear test (P = .0051) and in fluorescein corneal staining (P = .0003) vs. Restasis.
“The efficacy endpoints exceeded our expectations,” Neil Solomons, MD, Aurinia’s chief medical officer, said in the release. The company intends to pursue development of the drug.
Perspective
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At every meeting you have ever attended at which a new medicine (or new form of an older medicine) is presented, you and everyone else there has only one question you want answered: How does drug X (new drug) compare with drug Y (old drug)? That question goes unanswered every single time. Literally. No one ever does that study because of the expense involved (they must buy the drug at retail prices), and they certainly don’t do it as part of an FDA application. No one. Never.
Unless you are Aurinia. Head to head against Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) in the exact kind of study every dry eye disease (DED) doctor wants, VOS (voclosporin 0.2%) was found to be significantly more effective in increasing Schirmer results and decreasing corneal staining. Subjects tolerated VOS as well as, but not better than, Restasis (technically a missed primary endpoint); there was a “substantial and statistically significant” improvement in SANDE symptom scores. According to the release, VOS was superior to Restasis in every clinical measure evaluated and equally well tolerated.
This is a really big deal, at least as big as the introduction of lifitegrast. The underlying science looks solid. If these findings are borne out in the expected phase 3 trials, then we are potentially looking at a true breakthrough medication in the treatment of symptomatic DED. Again, if the follow-up trials show the same degree of effect and speed of onset, we will have on hand a medication that does everything we want it to do for our patients: rapidly improve the signs and symptoms of dry eye.
At least from this opening salvo, Aurinia is a company to be reckoned with. It did the exact trial practicing doctors want to see, head to head against the reigning class leader. Allow me to be the first to suggest pitting VOS against Xiidra (lifitegrast ophthalmic solution 5%, Shire).