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Ocular (OCUL) Announces Positive Data on Wet AMD Candidate

Ocular Therapeutix, Inc. OCUL recently announced positive interim seven-month data on its ophthalmology candidate OTX-TKI from a phase I trial to treat wet age-related macular degeneration (wet AMD) conducted in the United States. Consequently, shares are up in pre-market trading.

OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, evaluated for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.

The U.S.-based phase I study is a prospective, multi-center, randomized, controlled study that is evaluating a 600 µg dose of OTX-TKI in a single implant, with a 2 mg aflibercept injection four weeks after the implant, compared to 2 mg aflibercept injections administered every eight weeks in subjects previously treated with anti-VEGF therapy.

The trial will evaluate the safety, durability and tolerability of OTX-TKI. It will also assess biological activity in subjects by measuring visual acuity and anatomical changes in the retina using optical coherence tomography.

The study enrolled 21 subjects at six clinical sites in the United States, who were randomized 3:1 to the OTX-TKI arm or the on-label every eight-week aflibercept injection arm.

The interim results showed subjects treated with a single OTX-TKI implant demonstrated stable and sustained best corrected visual acuity (BCVA) (mean change from baseline of -1.3 letters) and central subfield thickness (CSFT) (mean change from baseline of +9.2 µm) in the OTX-TKI arm at seven months. This is comparable with the aflibercept arm dosed every eight weeks (mean change from BVCA baseline of -1 letter; mean change from CSFT baseline of +0.4 µm).

The data also showed that 80% of subjects in the OTX-TKI arm were rescue-free for up to six months, and 73% of subjects in the OTX-TKI arm were rescue-free for up to seven months.

OTX-TKI was well tolerated and demonstrated a favorable safety profile with no drug-related ocular or systemic serious adverse events (SAEs).

As a result, Ocular plans to complete its analysis of the interim data in the United States and meet with the FDA to discuss potential future clinical trial requirements. It intends to initiate a phase II wet AMD study in the third quarter of 2023, subject to these discussions.

In addition, the company targets to initiate a U.S.-based phase I study to evaluate OTX-TKI for treating diabetic retinopathy in the first quarter of 2023.

Shares of the company have lost 24.2% so far this year compared to the industry’s decline of 30%.


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Ocular’s first commercial drug product, Dextenza, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.

The successful development of OTX-TKI will broaden its portfolio further.

Aflibercept is marketed under the brand name Eylea.

Eylea is an anti-VEGF treatment developed by Regeneron REGN in collaboration with Bayer’s BAYRY.  The FDA has approved Regeneron/Bayer’s Eylea for multiple retinal indications, including DME, wet AMD and retinal vein occlusion.

While REGN records net product sales of Eylea in the United States, BAYRY records net product sales of Eylea outside the country.

Zacks Rank & Stocks to Consider

Ocular currently carries a Zacks Rank #3 (Hold).  A better-ranked stock in the healthcare sector is Bolt Pharmaceuticals BOLT, which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.


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