Ocuphire Pharma, Inc. (NASDAQ:OCUP)

Ocuphire is a developer of new therapies for ophthalmic indications with a huge calendar of catalysts for this year.

The company’s lead drug, an ophthalmic solution of phentolamine called Nyxol, is designed to inhibit the contraction of smooth muscles in the iris. The potential applications for this eye therapy are huge for this small company. Moreover, developmental risk has been reduced after the company reported positive Phase 3 data on Monday.

In a Phase 3 trial for pharmaceutically induced mydriasis, Nyxol produced statistically significant clinical results that met the trial’s primary goal.

Pharmaceutical mydriasis is just a fancy name for having your eyes dilated with a drug, something we’ve all experienced after a visit to the ophthalmologist for an eye exam. Then you end up walking around with hazy vision for hours and having to wear sunglasses to cut the glare from your dilated pupils. I’ve sometimes been worried about driving home in bright sunshine after a visit to the eye doctor because of this.

Half of subjects who got Nyxol drops after dilation saw their pupils return to their original diameter 90 minutes after. That’s a big improvement over the 7% in the control group who received placebo.

Plus, the eye drop therapy showed it was tolerable and safe.

The business case for Nyxol here is clear. Tens of millions of eye exams are conducted in the U.S. every year, and patients can be vision impaired due to dilation for up to 24 hours.

But Nyxol could become an important therapy in other eye indications, like dim-light or night-vision disturbances. Millions of people with DLD problems have impaired night vision when their pupils enlarge to take in more light. These issues can be caused by intraocular lens implants, LASIK, cortical cataracts and more. A moderate decrease in pupil size could help improve night vision for millions.

The company is also studying Nyxol in combination with another drug for use in presbyopia, which is something that affects many of us as we age. I started noticing it when I turned 40. As we get older, the lenses in our eyes become less elastic, so they aren’t able to flex as much.

This age-related farsightedness means we lose some ability to focus on objects that are close-up, leading us to resort to reading glasses, bifocals or progressive lenses to compensate. Reducing pupil size can help with short-distance vision, and in early trials Nyxol showed evidence of improvement as measured by vision tests. Patients could read more lines.

Imagine taking an eye drop once or twice per day and having more precise short-distance vision. A product like that could help millions and be worth billions.

The company is also looking into combining Nyxol in combination with latanoprost for the treatment of glaucoma. And as I mentioned earlier, the company has a catalyst-rich year ahead of it.

Early next year, the company expects Phase 2 data for a different drug, an oral pill called APX3330. APX3330 works over multiple biological pathways to reduce the production of new blood vessels and to reduce inflammation. The trial is set to begin later this year and will examine the effect of this drug on people with diabetic retinopathy and diabetic macular edema.

With Nyxol, Ocuphire just reported great Phase 3 data in pharmaceutically induced mydriasis, but there’s a Phase 2 readout in presbyopia expected in the second quarter. Plus, there’s Phase 3 data in DLD expected in the third quarter. These are huge catalysts that could really move OCUP’s valuation far beyond its current market cap of $76 million.

Phase I results for Supinoxin and RX-3117 should be released later in H1 2015 and Phase 2b for Archexin in H2 2015.

The release of positive data from any of these studies will result in a significant uptick in the stock price. More importantly, a positive result from the Archexin study will generate strong partnership interest.