Oculis S.A., (‘Oculis’) a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, announces that the Phase 2 DX-211, a randomized, double blinded, multi-center and vehicle controlled clinical trial assessing the safety and efficacy of topical OCS-01 in patients with Diabetic Macular Edema (DME) (NCT05343156) has been published by the Acta Ophthalmologica journal. The publication is accessible on the National Institutes of Health (NIH) website here ( https://pubmed.ncbi.nlm.nih.gov/35848336/ ). In addition, a new subgroup analysis of this study was also recently presented by Pr R. Tadayoni at the 22nd EURETINA Congress on 2nd September in Hamburg, Germany.
— Positive Phase 2 data, published in journal ACTA, provides the first proof-of-concept for a topical drug effect in diabetic macular edema (DME)
— Dataset shows that OCS-01 eye drops were more effective than vehicle in reducing central macular thickness and improving visual acuity in patients with DME as per the pre-defined criteria for statistical superiority in the study protocol
— Subgroup analysis, presented by Pr Ramin Tadayoni at EURETINA, suggests even greater improvement in patients with lower baseline visual acuity
— If approved, OCS-01 has the potential to provide a new and potentially the FIRST non-invasive eye drop option for DME patients
The dataset published shows OCS-01 to be superior to vehicle in the primary efficacy analysis of BCVA change from baseline with a between group difference of +1.58 ETDRS letters at the pre-specified significance level of 0.15. Mean CMT showed a statistically significant greater decrease from baseline in the OCS-01 group compared to vehicle at all post-baseline time points up to and including Week 12 (-54micrometer OCS-01 vs. -17micrometer vehicle) and reversed towards baseline when treatment stopped at 12 weeks, demonstrating the pharmacological effect of OCS-01 on retinal edema. OCS-01 was well tolerated and no significant or unanticipated ocular adverse events were observed.
Subgroup analysis in patients with BCVA baseline is less than or equal to 65 letters, presented at EURETINA 2022, showed greater improvements in both CMT (-77.4micrometer OCS-01 vs. -23.1micrometer vehicle) and BCVA (+2.9 ETDRS letters in OCS-01 vs vehicle) at week 12.
Approximately 37 million people are affected by DME worldwide, representing around 7% of the large and growing diabetes patient population. DME is the build-up of fluid (edema) in the macula (the macula is important for the sharp, straight-ahead vision that is used for reading, recognizing faces, and driving). DME is the most common cause of vision loss among people with diabetic retinopathy and a leading cause of new cases of blindness in US adults. Although treatment options currently exist, all of them are invasive (injections or implants) and represent a significant burden for patients and caregivers.
OCS-01 is a novel, high concentration, preservative free, topical formulation of dexamethasone that has the potential to be the first topical eye drop and non-invasive treatment for DME. OCS-01 opens up the possibility of treating DME patients at all stages of disease with an eye drop. In addition, OCS-01 could increase the accessibility to treatment of those patients without easy access to specialists; together, this could significantly reduce the burden to the health care system and improve patient outcomes and quality of life.
OCS-01 is currently under investigation for the treatment of DME in the ongoing Phase 3 DIAMOND trial to confirm these findings in a larger patient population.
Riad Sherif, M.D., CEO of Oculis, said: “We are delighted by these data from the Phase 2 DX-211 study, which further reinforce the potential of OCS-01 to provide patients with a potentially transformative treatment of DME as the first non-invasive, eye drop, option. An effective topical treatment for DME could expand the proportion of patients treated, especially those with recent onset DME, as well as provide a treatment option to general ophthalmologists prior to referral to a retina specialist and thereby, improving access to treatment. We look forward to the results of the ongoing Phase 3 DIAMOND trial as Oculis seeks to deliver life-changing treatments that can be accessed globally for the world’s most prevalent ocular diseases.”
Pr Ramin Tadayoni, MD, PhD, Professor of Ophthalmology at Universite de Paris, said: “The development of effective topical eye drops for posterior segment disorders such as DME would offer easier, non-invasive options than those currently available, and could be widely adopted across all socioeconomic and geographic boundaries. This would allow earlier treatment in DME, reduce the burden on both patients and their caregivers with potentially less injections per year if combined with current standard of care, increase adherence and ultimately, improve outcomes worldwide. OCS-01 is the most developed and promising topical therapy for DME to date, and I look forward to its further development as a potentially transformative treatment for patients in need.”
About Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis’s highly differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Topic: Press release summary