Biotech Currents

Biotech Currents

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Biotech Currents
Biotech Currents
SanaCurrents on the FDA decision for Ocuphire's Nyxol eye drops for consumers | $OCUP

SanaCurrents on the FDA decision for Ocuphire's Nyxol eye drops for consumers | $OCUP

Bill Langbein
May 12, 2023
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Biotech Currents
Biotech Currents
SanaCurrents on the FDA decision for Ocuphire's Nyxol eye drops for consumers | $OCUP
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SUMMARY

Drugs in development to treat life-threatening diseases or chronic, debilitating conditions typically produce the highest returns. Yet drugs to treat benign conditions also must be tested in clinical trials and receive FDA approval. Such is the case for Ocuphire Pharma, Inc.’s (NASDAQ:OCUP) Nyxol eye drops.

Ocuphire expects it can apply Nyxol to several ophthalmic conditions, the first of which is mydriasis (RM), or dilation of the eyes. Dilated pupils occur when the black center of the eye become larger than normal. Dilation in the eyes generally manifests when a medication is applied to enable a physician to examine the back of the eye. There is no approved treatment for the condition, even though it can take 6 to 24 hours for the eye to return to normal. During that time, patients can experience sensitivity to light, dizziness and blurred vision. Current “non-treatment” is to let the conditions fade away on an individual basis. Ocuphire tested Nyxol in four phase III trials to treat pharmacologically-induced mydrasis and now has a PDUFA date for the indication of September 28, 2023.

Next Key catalysts

  • PDUFA decision for Nyxol drops to treat Mydriasis (RM), or dilation of the eyes

Key catalyst dates

  • September 28, 2023

Sentiment, MACE Score & The Edge….

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