Oculis Taps Legal Heavyweight to Steer Pivotal Pipeline Push

ZUG, Switzerland – February 17, 2026 – Oculis Holding AG, a global biopharmaceutical firm at the forefront of ophthalmic innovation, has fortified its executive leadership by appointing Katie Kazem as its new Chief Legal Officer. The move signals a strategic reinforcement of the company’s legal and governance framework as it approaches a series of critical clinical and regulatory milestones for its late-stage drug pipeline.

Ms. Kazem, a former capital markets partner at the international law firm Cooley LLP, will now lead Oculis’s legal, compliance, and corporate governance functions. The appointment comes at a moment of intense activity for the dual-listed company (Nasdaq: OCS / XICE: OCS), which is preparing for high-stakes data readouts that could reshape treatment paradigms for major eye diseases.

"Katie joins Oculis at an exciting moment, with Privosegtor advancing into the PIONEER program with registrational trials for a novel neuroprotective platform and just ahead of the much‑anticipated DIAMOND Phase 3 topline results for OCS‑01 eye drops in DME, expected in Q2," said Riad Sherif, M.D., Chief Executive Officer of Oculis. "This significant momentum reinforces our commitment to delivering transformational therapies. I look forward to working alongside Katie as we continue to make rapid progress across our highly differentiated pipeline and prepare for important late‑stage clinical, regulatory, and commercial milestones."

A Strategic Hire at a Pivotal Moment

The timing of Kazem's appointment is no coincidence. Oculis is standing on the precipice of potentially transformative results for its lead product candidates. The most anticipated is OCS-01, an eye drop formulation aiming to become the first-ever non-invasive topical treatment for diabetic macular edema (DME), a leading cause of blindness in working-age adults. The current standard of care involves invasive, and often burdensome, injections directly into the eye. With topline Phase 3 data expected in the second quarter of 2026 and a planned New Drug Application (NDA) submission to the FDA by year-end, the company is transitioning from a clinical-development focus to a potential commercial powerhouse.

Successfully navigating this transition requires ironclad legal and regulatory expertise. Kazem’s role will be instrumental in steering the complex NDA submission process, ensuring compliance with stringent FDA requirements, and preparing the legal groundwork for a potential product launch in a competitive market dominated by established injectable therapies like Eylea and Vabysmo.

Simultaneously, the company’s neuroprotective candidate, Privosegtor, is advancing into a registrational program for optic neuropathies. The significance of this asset was recently underscored when the U.S. FDA granted it Breakthrough Therapy Designation in January 2026 for the treatment of acute optic neuritis. This designation is reserved for drugs that may demonstrate substantial improvement over available therapy and is intended to expedite development and review. Guiding a drug with this designation through its final clinical and regulatory stages demands sophisticated legal oversight, a challenge for which Kazem’s background is well-suited.

From External Counsel to Internal Leader

A key aspect of this executive appointment is Kazem’s pre-existing relationship with Oculis. She has served as the company's external legal counsel since its U.S. public debut on the NASDAQ exchange in March 2023. This history provides her with an invaluable head start, eliminating the typical learning curve associated with a senior executive hire.

Her prior involvement means she possesses deep institutional knowledge of Oculis’s corporate structure, its intellectual property portfolio, its strategic objectives, and its existing legal and compliance frameworks. This continuity is a significant advantage in the fast-paced biotech sector, where speed and precision are paramount.

"I am honoured to be joining Oculis at such an important stage of the company’s journey to become a global leader in neuro-ophthalmology and ophthalmology," Kazem stated. "Over the past few years, I have had the privilege of serving as external legal counsel to Oculis... which allowed me to work closely with its exceptional executive team and board of directors, witness the company’s remarkable progress and unwavering business integrity, and gain deeper insight into its highly promising pipeline. I look forward to continuing this collaboration as we advance the company’s late‑stage assets toward future clinical milestones and commercialization.”

This transition from an external advisor to an internal leader suggests a seamless integration into the executive team, allowing for immediate impact on the strategic decisions facing the company as it navigates its most critical period to date.

Navigating the Complexities of a Dual-Listed Global Player

Beyond her familiarity with Oculis, Kazem brings a highly specialized skill set that is particularly crucial for the company's unique corporate structure. With over 15 years of experience, her tenure at Cooley saw her become a go-to expert for European life sciences companies seeking to navigate the U.S. capital markets. Oculis, headquartered in Switzerland with operations in the U.S. and Iceland, is dual-listed on the NASDAQ in the United States and the XICE in Iceland.

This dual-listing structure, while offering access to a broader pool of international investors, creates a complex web of regulatory obligations. The company must simultaneously adhere to the rules of the U.S. Securities and Exchange Commission (SEC) and NASDAQ, as well as European and Icelandic financial authorities. Kazem's track record includes advising numerous dual-listed biotechs through their IPOs and subsequent compliance needs, including high-profile transactions for companies like Valneva SE, Nanobiotix SA, and Genfit SA.

Her expertise will be vital in managing the distinct disclosure requirements, corporate governance standards, and investor relations strategies required for each market. As a foreign private issuer in the U.S., Oculis can follow certain home-country governance practices, but navigating this hybrid model requires nuanced legal guidance to ensure full compliance and maintain investor confidence on both sides of the Atlantic. Kazem’s appointment provides Oculis with in-house leadership specifically equipped to manage these cross-border challenges, a critical asset for any future capital raising, strategic partnerships, or M&A activities.

Fortifying for a Competitive Commercial Landscape

Ultimately, this strategic legal appointment is about preparing Oculis for commercial reality. The potential launch of OCS-01 for DME would pit the company against pharmaceutical giants in a multibillion-dollar market. While its non-invasive eye drop form presents a powerful differentiator, successfully carving out market share will require a robust commercial and legal strategy covering everything from marketing compliance to intellectual property defense.

The U.S. market for diagnosed DME alone is estimated at 1.8 million people, representing a significant opportunity for a novel, patient-friendly treatment. Analyst sentiment has remained broadly positive on Oculis, with multiple firms issuing "Buy" or "Outperform" ratings in recent months, reflecting confidence in the pipeline's potential.

By bringing a seasoned legal expert like Katie Kazem in-house, Oculis is not just preparing for its upcoming regulatory submissions; it is building the corporate infrastructure needed to evolve from a promising clinical-stage company into a sustainable, commercial-stage global biopharmaceutical leader. Her leadership will be fundamental in protecting the company’s innovations and maximizing the value of its assets as they move from the laboratory to the market.