Outlook Therapeutics OTLK reported preliminary top-line results from the 90-day non-inferiority NORSE EIGHT clinical study evaluating ONS-5010 (Lytenava) to treat patients with wet age-related macular degeneration (AMD). The NORSE EIGHT study is the second of two adequate and well-controlled clinical studies evaluating ONS-5010 for the AMD indication.
Per the data readout, the candidate failed to meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment with the FDA. ONS-5010 is an investigational ophthalmic formulation of bevacizumab, which is being developed to treat AMD and other retinal diseases. Shares of Outlook Therapeutics plunged 65.2% on Wednesday in response to the news.
The NORSE EIGHT non-inferiority study enrolled newly diagnosed wet AMD patients, who were randomly divided equally to receive either 1.25 mg ONS-5010 or 0.5 mg Lucentis (ranibizumab) intravitreal injections. All subjects were dosed thrice during the study period. The primary endpoint of the study was the mean change in best-corrected visual acuity from baseline to week eight.
However, preliminary analysis of study data showed vision improvement, biological activity and a favorable safety profile for ONS-5010. Treatment with the candidate was also well-tolerated in the NORSE EIGHT study with overall ocular adverse event rates comparable to Lucentis. The safety profile of ONS-5010 observed in the NORSE EIGHT study was consistent with that observed in prior clinical studies, with no cases of retinal vasculitis reported in either study arm.
Further analysis of the NORSE EIGHT study data is currently ongoing with full three-month results expected to be reported in January 2025. Following the availability of the detailed three-month efficacy and safety data, Outlook Therapeutics plans to resubmit the biologics license application (BLA) for ONS-5010 in the first quarter of 2025. Year to date, shares of OTLK have plummeted 78.4% compared with the industry’s 7.8% decline.
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We remind the investors that in August 2023, Outlook Therapeutics received a complete response letter (CRL) from the FDA regarding the BLA for ONS-5010.
The FDA stated concerns related to chemistry, manufacturing, and controls and open observations of the manufacturing process, which were made during pre-approval inspections. Additionally, the regulatory body had cited that there was “a lack of substantial evidence” and asked for a second adequate and well-controlled study to be conducted. The first BLA was based on a phase III NORSE TWO study evaluating the safety and efficiency of ONS-5010 compared with ranibizumab for treating wet AMD.
In the latest press release, Outlook Therapeutics reported that it has successfully remediated the chemistry, manufacturing and controls issues raised by the FDA which formed the basis of the earlier CRL.
Approval of OTLK’s ONS-5010/Lytenava Outside the US
Please note that ONS-5010 received regulatory approval in the EU and the U.K. earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab to treat wet AMD. The drug will be marketed under the brand name, Lytenava.
Outlook Therapeutics plans to launch Lytenava in the U.K. and Germany in 2025, either independently or through a licensing partner. Dialogues with potential licensing partners for markets outside of the United States are ongoing.
The company is confident that ONS-5010/Lytenava is a critical therapy for wet AMD, offering a regulated alternative to off-label repackaged Avastin (bevacizumab), which is not approved for ophthalmic use.
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Zacks Rank and Stocks to Consider
Outlook currently carries a Zacks Rank #3 (Hold).
Some better-ranked pharma stocks are Allogene Therapeutics ALLO, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 21.5% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
Over the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 10.6% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.
Over the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024 while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 12.8% year to date.
Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.
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