OKYO Pharma (NASDAQ: $OKYO), a clinical stage biopharmaceutical company, announced a major stability milestone for its drug candidate urcosimod on Monday, March 31, 2025.
Details Of The Trial
According to the announcement, the Phase 2b clinical trials for use of urcosimod in alleviating Neuropathic Corneal Pain (NCP) has demonstrated positive stability in single use ampoules. The ampoules were in storage for over 2 and a half years under refrigeration, with stability rates of 94.8%, for a concentration of 0.05%, and 97.4% for a concentration of 0.1%.
Stability testing is one of the key FDA requirements before approval. It addresses the shelf-life concerns for this promising drug candidate. Additionally, room temperature stability results are promising, with 100% stability rates. The company noted that use of single-use ampoules was increasingly preferred for ophthalmic medication over plastic bottles. They offer better sterility control for long-term daily use.
Urcosimod is currently undergoing a trial involving 48 patients with NCP, which currently lacks an FDA-approved treatment. The drug is also a candidate for treating inflammatory dry eye disease (DED), presenting a multi-billion-dollar market opportunity.
What The Leadership Team Had to Say
Commenting on the announcement, Okyo Pharma CEO, Gary S. Jacob, Ph.D., said that, “One of the major requirements for drug approval is that the drug is stable to degradation for a considerable period of time. This addresses the issue of shelf stability for a drug, and the fact that we have now established this for urcosimod is a critical positive step in meeting CMC requirements for a successful New Drug Application (NDA) with FDA.”
According to OKYO Pharma Chief Scientific Officer Raj Patil, Ph.D., they were also “conducting long-term stability testing of urcosimod at room temperature, and so far, the 3-month results at room temperature are at or above 100%. It’s important to highlight that urcosimod is administered to patients as eye drops, and we have been pleased not only with the drop comfort score observed with this drug but also with the efficacy results from an earlier trial of urcosimod to treat DED. These positive results have fueled our excitement for this drug’s potential to treat NCP.”
OKYO Pharma (OKYO) Market Performance
On March 31, 2025, at the closing bell, OKYO was trading at $1.2700. It is up 10.43% year to date, and 24.51% in the past six months. The stock is trading above its 50 and 200-day moving averages of $ 1.2084, and $1.1467, respectively.
Is OKYO Pharma A Buy After Its Latest Announcement?
The stability data released by OKYO Pharma marks a major milestone in the path to regulatory approval. It is worth noting that many promising drug candidates often fail FDA approval due to formulation stability issues.
The high percentage stability of over 97% at the 0.1% concentration is especially impressive for a drug candidate in the ophthalmic field. With room temperature stability at 100% for 3 months, it further bolsters the commercial viability of the drug candidate.
While the ongoing efficacy trial is the main value driver, the recent stability results significantly enhance the chances of regulatory approval. It sets a clear path to potential commercialization in the lucrative dry eye disease sector, which OKYO Pharma notes is valued at billions of dollars. Consequently, adding OKYO to your portfolio could potentially have a positive impact on your portfolio in the long term.
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