Dive Brief:
- Clinical-stage biotech EyeGate Pharmaceuticals Inc.'s lead experimental product, called EGP-437, stumbled in a Phase 2a study, failing to significantly reduce pain and inflammation in patients who had previously undergone cataract surgery.
- While Eyegate's formulation of dexamethasone showed numerically superior results than the placebo vehicle, neither of the co-primary endpoints evaluating anterior chamber cell count and pain scores met the threshold for statistical significance.
- EyeGate said it will continue to review the data from this study, and will plans to advance EGP-437's development in ocular surgery.
Dive Insight:
Across the U.S. there were around 3.6 million cataract surgeries in 2015, a trend likely to increase as the population ages. Cataract surgery can dramatically improve quality of life, allowing people to keep working, for example. However, pain, swelling and inflammation can continue for days and weeks after surgery, and these side effects are the target of EyeGate's lead product.
The data is a setback for the product, which delivers dexamethasone across the sclera through a delivery platform developed by EyeGate.
The company blames a higher-than-expected response in the control group.
"The efficacy results for the absence of inflammatory cells in the EGP-437 treatment group met our expectations, but the vehicle group response was better than anticipated," said Randall Olson, a strategic advisor to EyeGate. "The magnitude of reduction for EGP-437 compares favorably with the historical data from studies of other anti-inflammatory products, which we believe is an encouraging sign."
The company isn't sending the post-cataract surgery program to the scrap heap just yet, pledging to review the data to determine next steps.
EGP-437 is also in development for non-infectious anterior uveitis. A pivotal Phase 3 trial reached 75% recruitment in December 2017, with topline data expected in the second quarter of 2018. This has triggered a milestone payment from licensee Valeant Pharmaceuticals International Inc., which holds exclusive global commercial and manufacturing rights to the treatment in uveitis and in post-operative ocular inflammation and pain in ocular surgery patients.