Drug development isn’t known for being fast-paced, and developing any new drug is generally a long process. However, OKYO Pharma Ltd. (NASDAQ: OKYO) is moving quickly to develop its eye treatment drug, OK-101. It plans to begin trials for the drug in the 2nd quarter of 2023.

OKYO Pharma is a biopharmaceutical company developing a treatment for Dry Eye Disease (DED). DED, a common disease often associated with aging, results in impaired vision, pain and eyesight fatigue. Treatments for DED currently cost healthcare systems and patients over $50 billion annually, and no drugs on the market are fully effective.

OKYO Pharma is developing a novel treatment for DED and plans on initiating a phase 2 efficacy trial for OK-101 within the next 1-3 months. The company anticipates releasing topline data on its 240-patient trial in DED patients by the fourth quarter of 2023. If the trial meets its pre-specified endpoints, the timeline for the drug’s approval could be significantly accelerated.

Food and Drug Administration (FDA)-approved treatments are notoriously slow to develop and require two well controlled double-blind registration phase 3 trials as the major support for drug approval. Collecting thise data for a new drug application (NDA) with the FDA normally involves three phases of clinical trials. Phase 1 is conducted solely with volunteers, and tests for drug safety. Phase 2 includes patients but typically starts with dose escalation studies for building data around safety. Finally, phase 3 involves two registration trials, where the focus is on establishing drug efficacy and further building support for drug safety. It typically takes an average of 10 years for companies to go from an initial concept performed in animal studies to get all the way to FDA approval, and it sometimes even takes much longer than that.

OKYO Pharma, which was founded in 2018, will have efficacy data available by the end of this year, meaning it may be in a position to get approval with only five or so years of drug development. OKYO is able to move fast with its drug development because the treatment is delivered topically as eye drops, so it doesn’t risk getting into the blood and has virtually no systemic exposure, and the company is additionally designing the clinical phase 2 trial with the inclusion of pre-specified primary endpoints, a hallmark of phase 3 trials.

Phase 2 Efficacy Trial Begins March 2023

OKYO Pharma filed an Investigational New Drug (IND) application in November, and now it’s starting a phase 2 efficacy trial on DED patients in the 2nd quarter of 2023. The trial will be conducted as a double-blind placebo-controlled trialtrial with the inclusion of pre-specified primary endpoints, meaning the data collected here could count towards its registration trials. The company has said it’s conducting these trials through the contract research organization (CRO) Ora Inc. Ora is a world-class ophthalmologically-focused CRO. It has seen over 50 product approvals and has been involved in developing three FDA-approved ocular drugs.

OKYO Pharma is led by Dr. Gary S. Jacob, who has a proven track record of drug development and has already brought two FDA drugs to market. Dr. Jacob has also remarked on the solid intellectual property (IP) estate for the drug, including patents issued on the drug composition and its use to treat DED patients. The company views this IP estate as an important component of the OK-101 franchise. It serves to ensure drug exclusivity should the company eventually seek a merger or acquisition as it continues to develop and market the drug.

Preliminary preclinical trials in animals suggest OK-101 is effective at both reducing ocular inflammation and decreasing the corneal neuropathic pain that comes from nerve damage. The drug works by latching onto an ocular immune cell receptor, ChemR23. This receptor protects the eyes from infection by activating a pro-inflammatory response. Often this is good, but DED causes chronic inflammation which can lead to serious damage to the cornea as well as to the ocular nerves. OK-101 has a modified chemerin that includes a 9-mer highly-stable peptide. This peptide binds to the receptor, initiating an anti-inflammatory response in the eye, as well as decreasing the ocular pain.

Comparable companies in the ocular and retinal disease space include Aldeyra Therapeutics (NASDAQ: ALDX), Ocular Therapeutix (NASDAQ: OCUL) and Tarsus Pharmaceuticals (NASDAQ: TARS).