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ZUG, Switzerland - Oculis Holding AG (NASDAQ:OCS / ICX:OCS.IC), a biopharmaceutical company with a market capitalization of $860 million, has announced the completion of patient enrollment for its Phase 3 DIAMOND-1 and DIAMOND-2 trials, which are evaluating OCS-01 eye drops as a treatment for diabetic macular edema (DME). According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it remains pre-revenue with just $760,000 in revenue over the last twelve months. The trials have enrolled over 800 patients across 119 global sites, primarily in the U.S., marking a significant milestone in the development of what could be the first topical treatment for DME.
The DIAMOND program consists of two randomized, double-masked, multi-center trials designed to assess the efficacy and safety of OCS-01 following a 52-week treatment period. Topline data from these trials is expected in the second quarter of 2026, with a subsequent New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). Investors tracking this milestone should note that Oculis's next earnings report is scheduled for May 8, 2025, where management may provide additional program updates.
OCS-01, leveraging Oculis' proprietary OPTIREACH® technology, is a high-concentration dexamethasone eye drop that aims to offer a non-invasive treatment alternative for DME, a condition that currently requires invasive procedures like injections or implants. The OPTIREACH® technology is designed to improve drug solubility and ocular retention, facilitating drug delivery to the posterior segment of the eye.
DME is a major cause of vision loss in diabetic patients, with an estimated 37 million individuals affected worldwide. This number is projected to rise to 53 million by 2040. While InvestingPro analysis indicates the company isn't currently profitable, analysts are closely watching this market opportunity, with price targets ranging from $23 to $43 per share, suggesting significant potential upside if clinical trials succeed. The Phase 3 trials were initiated based on positive results from the earlier stage of the DIAMOND program, announced in the second quarter of 2023.
Riad Sherif, M.D., CEO of Oculis, expressed gratitude to all stakeholders for their support in advancing the program towards NDA submission. Arshad M. Khanani, M.D., M.A, FASRS, Chairperson of the DIAMOND Program Steering Committee, noted the strong progress of OCS-01 and the high level of interest from both investigators and patients in a topical eye drop treatment for DME.
An update on the DIAMOND program and Oculis' late-stage pipeline will be provided at the upcoming R&D Day on Tuesday, April 15. Oculis focuses on addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs. OCS-01 is currently an investigational drug and has not yet received regulatory approval.
This article is based on a press release statement from Oculis Holding AG.
In other recent news, Oculis Holding AG reported its financial results for 2024, revealing grant income of CHF 0.7 million and a net loss of CHF 85.8 million, or (CHF 2.12) per share. Despite the loss, the company maintains a strong cash position, with $109 million in cash and equivalents at the end of the fourth quarter, supported by a $93 million financing round. H.C. Wainwright adjusted its price target for Oculis to $29, down from $30, while maintaining a Buy rating, citing the increased market value and outstanding shares. Stifel analysts also reiterated a Buy rating, setting their price target at $35, following positive results from the Phase 2 ACUITY trial for OCS-05/privosegtor. Oculis is advancing its pipeline, with a New Drug Application for OCS-01 expected in early 2025 and ongoing Phase 3 trials for diabetic macular edema. The company has also confirmed a development path for licaminlimab (OCS-02) with the FDA and plans further discussions in 2025. These developments are part of Oculis's broader strategy to advance its clinical programs and engage with regulatory authorities.
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