Virtual KOL Roundtable Recap: Outlook Therapeutics and Firas Rahhal, MD, Discussed wet AMD Treatment Landscape and ONS-5010/LYTENAVA™
- Dr. Rahhal, a leading retinal clinician, offered insight on wet AMD treatment and the potential of ONS-5010/LYTENA
VA™ (bevacizumab-vikg), if approved, to improve available treatment options Outlook Therapeuticsdetailed ongoing development and pre-commercial planning of ONS-5010/LYTENANA™
- Webcast replay from the event is now available: click here
“Gaining perspective from a practicing clinician who frequently uses available anti-VEGF treatment options for his patients provides invaluable insight as we continue to advance the clinical development of our investigational ophthalmic formulation of bevacizumab, ONS-5010/LYTENAVA™. We believe ONS-5010, if approved, is strategically positioned to address many of the shortcomings in the treatment landscape for wet AMD that were discussed during the Roundtable, as it would offer patients and clinicians an approved ophthalmic formulation of a therapeutic that is already widely used. We thank
The Roundtable opened with a discussion of current treatment options for retinal diseases, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Such retinal diseases are characterized by excessive growth of abnormal blood vessels under the retina, which if untreated leads to vision loss and even blindness. Anti-VEGF medications control this abnormal growth, and for the past 15 years have become the standard of care for treating these diseases.
Bevacizumab is an anti-VEGF drug, but it is not approved for ophthalmic use. Although there are three anti-VEGF drugs currently approved to treat ophthalmic disease, they are extremely expensive. As a result, physicians who wish to treat their retinal patients with a less expensive anti-VEGF drug often use unapproved, repackaged IV bevacizumab from compounding pharmacists. ONS-5010, if approved, will be the first and only on-label ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD.
Payors have also weighed in on the value of bevacizumab in treating retinal diseases. Many now require use of off-label bevacizumab as a first-line treatment option before they will cover more expensive alternatives. The
Although he appreciates the significant cost savings of using off-label bevacizumab, he has at times encountered problems related to inconsistent potency, particulate contamination in the syringes, microbial contamination and syringe malfunctions. Problems can arise, he stated, as a result of variability across batches from different compounding pharmacies and from their storage practices. Additionally, silicone oil droplets can contaminate syringes, which when injected intravitreally, potentially can lead to an accumulation of silicone in patients’ eyes, causing vision problems.
“In my experience, there remains an unmet need for an FDA-approved and cGMP-produced bevacizumab that is specifically formulated for ophthalmic use. What the team at
Management Update on Outlook Therapeutics’ Development Program
The Roundtable concluded with an update from Outlook Therapeutics’ management on the current clinical development program and anticipated commercialization strategy for ONS-5010/LYTENAVA™. Management reported that the investigational compound is currently in Phase 3 registration clinical trials, with an expected read-out of pivotal data in mid-2021. Results from these trials will comprise the complete data package that is expected to be submitted to the
Outlook Therapeutics’ management emphasized that they intend to commercialize ONS-5010, if approved, at a responsible price, and in both unit-dose vials and pre-filled ophthalmic syringes. In anticipation of a first approval from the FDA in mid-2022,
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 will reduce the need for use of unapproved repackaged IV bevacizumab from compounding pharmacists for retinal disease.
ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally.
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “potential,” “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include statements about ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, the ability of ONS-5010 to gain widespread acceptance in the retinal treatment community, the timing of completion of, and pivotal safety and efficacy data from, the pivotal Phase 3 trial, the timing of BLA submission and sufficiency of exposures to support such submission, statements about commercial launch of ONS-5010, and plans for regulatory approvals in other markets. Although
Assistant Vice President
Chief Executive Officer
Source: Outlook Therapeutics, Inc.