Oculis | MedPath

Oculis Completes Enrollment in Phase 3 DIAMOND Trials for First-Ever Topical DME Treatment

a month ago

• Oculis has successfully enrolled over 800 patients across 119 global sites in its DIAMOND Phase 3 trials evaluating OCS-01, the first-ever topical eye drop treatment for diabetic macular edema. • The DIAMOND program represents a potential paradigm shift in DME treatment, offering a non-invasive alternative to current therapies that require intravitreal injections or ocular implants. • Topline data from both Phase 3 trials is expected in Q2 2026, with NDA submission to follow, potentially addressing the needs of millions of patients with this leading cause of vision loss in diabetics.

Oculis Expands Privosegtor Development to NAION and Multiple Sclerosis Following Positive Phase 2 Results

2 months ago

• Oculis announced the expansion of Privosegtor (OCS-05) development beyond acute optic neuritis to include non-arteritic anterior ischemic optic neuritis (NAION) and acute relapses in multiple sclerosis patients. • The company has completed enrollment of over 800 patients in two Phase 3 DIAMOND trials for OCS-01 eye drops in diabetic macular edema, with topline data anticipated in Q2 2026. • Licaminlimab (OCS-02), a topical anti-TNFα biologic, is advancing with a genotype-based personalized approach for dry eye disease, with Phase 2/3 studies expected to begin in the second half of 2025.

Oculis Advances Novel Therapies for Ophthalmic Diseases with Promising Pipeline Development

3 months ago

• Oculis' OCS-05 demonstrates significant neuroprotective effects in acute optic neuritis patients, showing preserved retinal ganglion cells and reduced multiple sclerosis relapses in Phase 2 ACUITY trial. • The company's lead candidate OCS-01, utilizing OPTIREACH® technology, progresses in Phase 3 trials for diabetic macular edema, offering potential non-invasive alternative to intravitreal injections. • Oculis develops OCS-02, a TNF inhibitor with biomarker-driven approach for dry eye disease, representing a shift toward precision medicine in ophthalmic treatment.

Isomorphic Labs Secures $600M to Advance AI-Powered Drug Discovery Platform

3 months ago

• Isomorphic Labs raised $600 million in its first external funding round in March 2025, representing the largest private biotech investment of the month. • The funding will accelerate the company's frontier artificial intelligence research to enhance its next-generation AI drug design engine. • March 2025 showed strong biotech fundraising activity with over $2.2 billion raised across private and public rounds, making it the second-best month of 2025 thus far.

Phase 3 Trial Shows Promising Results for Novel Encapsulated Cell Therapy in MacTel Treatment

3 months ago

• Phase 3 clinical trials of NT-501, an encapsulated cell therapy delivering CNTF, demonstrated significant reduction in disease progression for macular telangiectasia type 2 patients, with up to 52% reduction in ellipsoid zone loss. • The innovative implantable device, developed by Neurotech, maintains long-term viability with CNTF production documented for up to 14.5 years, offering a potential alternative to frequent intravitreal injections. • FDA review of the therapy is currently underway with a PDUFA date set for March 18, 2025, marking a potential breakthrough in MacTel treatment.

FDA Approves Roche's Susvimo for Diabetic Macular Edema, Offering Fewer Injections

4 months ago

• The FDA has approved Roche's Susvimo (ranibizumab injection) for treating diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. • Susvimo is the first FDA-approved treatment for DME that requires fewer injections than standard eye injections, helping to maintain vision for affected individuals. • The approval was based on the Phase 3 Pagoda study, which demonstrated non-inferior vision improvements with Susvimo refilled every six months compared to monthly ranibizumab injections. • Susvimo, a refillable eye implant, delivers a customized formulation of ranibizumab continuously, offering a convenient alternative to routine eye injections for DME patients.

Ocular Therapeutix Advances AXPAXLI for Wet AMD and Plans NPDR Clinical Trial

4 months ago

• Ocular Therapeutix's SOL-R trial for AXPAXLI in wet AMD has enrolled 311 subjects, showing significant progress in the registrational program. • The SOL-1 trial, another registrational study for AXPAXLI in wet AMD, completed randomization in December 2024, with topline data expected in Q4 2025. • Ocular Therapeutix plans to seek FDA feedback in H1 2025 on the clinical trial design for AXPAXLI in non-proliferative diabetic retinopathy (NPDR). • Phase 1 HELIOS trial results showed a single AXPAXLI injection potentially reduces vision-threatening complications in NPDR patients.

Global Diabetic Retinopathy Clinical Trials Landscape Analysis Reveals Key Research Trends for 2024

4 months ago

• A comprehensive analysis of global diabetic retinopathy clinical trials has been released, offering insights into trial distribution across G7 and E7 countries and various research phases. • The report highlights significant trends in trial enrollment patterns over the past five years, providing valuable data for healthcare stakeholders and pharmaceutical companies. • The analysis covers detailed assessment of trial statuses, sponsor types, and endpoint evaluations, helping identify key opportunities and challenges in diabetic retinopathy research.

Oculis' OCS-05 Shows Promise in Phase 2 Trial for Acute Optic Neuritis

5 months ago

• Oculis Holding AG's OCS-05 met the primary safety endpoint and achieved statistically significant results in key secondary efficacy endpoints in the ACUITY trial. • The Phase 2 trial evaluated OCS-05 in patients with acute optic neuritis, demonstrating a favorable safety profile compared to placebo. • Treatment with OCS-05 resulted in significant improvements in retinal structure and visual function, suggesting neuroprotective benefits. • The FDA has cleared the IND application for OCS-05, enabling clinical development in the U.S. as part of a global program.

Oculis Price Target Increased by BofA Following Promising Phase 2 Trial Results

5 months ago

BofA has raised Oculis's price target from $23 to $31, maintaining a Buy rating, after the company reported positive Phase 2 results from the ACUITY trial for OCS-05 therapy in treating acute optic neuritis (AON). The trial demonstrated both safety and promising efficacy, leading to an increased modeled AON contribution from $10M to $330M.

Oculis Announces Q3 2024 Results and Pipeline Updates, Anticipates OCS-05 Phase 2 Data

7 months ago

• Oculis reports significant progress in its product pipeline, notably in the OCS-01 Phase 3 DIAMOND program for diabetic macular edema (DME) and the OCS-05 Phase 2 ACUITY trial for acute optic neuritis (AON). • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in AON in December 2024, which will provide insights into the safety, tolerability, and neuroprotective potential of OCS-05. • Oculis's leadership team has been strengthened with key appointments, and the company's cash reserves of $125.0 million are expected to fund operations into the second half of 2026. • The company plans to be NDA submission ready in Q1 2025 for OCS-01 for post-operative pain and inflammation, following a pre-NDA meeting with the FDA in August 2024.

Oculis Announces Q3 2024 Results and Pipeline Updates, Anticipates OCS-05 Data

7 months ago

• Oculis reports significant progress in its product pipeline, notably in the Phase 3 DIAMOND program for DME with OCS-01 and the Phase 2 ACUITY trial for AON with OCS-05. • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in acute optic neuritis in December 2024, offering insights into its neuroprotective potential. • Oculis is preparing for an NDA submission for OCS-01 in post-operative pain and inflammation by Q1 2025, following a pre-NDA meeting with the FDA. • With a strong cash position of $125.0 million, Oculis expects to fund operations into the second half of 2026, supporting its clinical development programs.

Oculis Announces Q3 2024 Results and Pipeline Updates, Anticipates OCS-05 Phase 2 Data

7 months ago

• Oculis reports significant progress in its product pipeline, including enrollment in the OCS-01 DIAMOND Phase 3 program for diabetic macular edema (DME). • The company anticipates topline results from the OCS-05 Phase 2 ACUITY trial in acute optic neuritis (AON) in December 2024. • Oculis' cash, cash equivalents, and short-term investments totaled $125.0 million as of September 30, 2024, funding operations into the second half of 2026.

Oculis Accelerates Enrollment in Phase 3 DME Trial for OCS-01 Eye Drops

7 months ago

• Oculis Holding AG reports accelerated enrollment in its DIAMOND Phase 3 trials for OCS-01 eye drops to treat diabetic macular edema (DME). • The DIAMOND-1 trial has enrolled approximately 70% of patients, while the DIAMOND-2 trial has reached about 40% enrollment. • Oculis has expanded its DIAMOND program committees, adding globally recognized retina experts to provide strategic oversight. • OCS-01, if approved, could become the first topical eye drop for DME, potentially transforming the current treatment approach.

Oculis Discontinues Phase III OCS-01 Trial Due to Administrative Error, Still Eyes 2025 NDA Submission

9 months ago

• Oculis is halting the Phase III OPTIMIZE-2 trial of OCS-01 eye drops for post-cataract surgery due to a third-party administrative error that compromised data analysis. • The FDA has indicated that data from the Phase III OPTIMIZE-1 trial and Phase II SKYGGN study are sufficient to support a New Drug Application (NDA) for OCS-01. • OCS-01 is being developed for post-operative inflammation and pain following ocular surgery, as well as diabetic macular edema (DME). • The NDA submission for OCS-01, which would be Oculis’ first, is planned for the first quarter of 2025.