At a KOL luncheon event held last week, leading retinal specialist, Dr. David Brown, outlined the shortcomings of current treatments for macular edema and discussed where CLS-TA for suprachoroidal administration, Clearside Biomedical’s (NASDAQ:CLSD) proprietary suspension formulation of the corticosteroid triamcinolone acetonide, could prove beneficial.
“Most notable was the physician’s positive reception to the data observed thus far, noting improvements in visual acuity and durations that are pushing past the ceiling seen with anti-VEGF treatment,” commented Stifel analyst Annabel Samimy, who attended the KOL event.
In a research note, Ms. Samimy writes that Dr. Brown also highlighted the ease of use of Clearside’s suprachoroidal CLA-TA; apparent benefit on adverse events, specifically intraocular pressure (IOP); potential to improve the patient experience; and potential to minimize overall treatment costs.
Clearside has demonstrated the potential benefit on IOP in the data so far, with only 8% of patients in all Phase 1 and Phase 2 trials of uveitis and retinal vein occlusion (RVO) experiencing increased IOP, (less than 5% excluding patients with pre-existing glaucoma).
According to Ms. Samimy, Dr. Brown noted that a product demonstrating less than 10% incidence of glaucoma, compared to up to 30% with other steroids, would be viewed very favorably by the ophthalmology community.
Clearside expects to release top-line Phase 3 data in the first quarter of 2018 from its PEACHTREE clinical trial, which is designed to evaluate the safety and efficacy of CLS-TA for suprachoroidal administration for the treatment of macular edema associated with non-infectious uveitis.
“A positive readout could yield an NDA filing in uveitis next year,” Ms. Samimy said, adding, “We expect the shares to gain momentum ahead of this catalyst.”
Ms. Samimy rates Clearside at “buy” with a price target of $18. The stock closed at $7.04 on Friday.
Dr. Brown also discussed typical practice patterns treating macular edema with RVO and diabetic macular edema (DME). Both long-duration steroid implants - Ozurdex and Iluvien - are used in conjunction with anti-VEGF treatment, administered with loading doses, followed by monthly administration.
In practice, however, physicians have sought to “stretch treatment,” but typically do not get past one-to-two weeks. In that vein, based on observations from Clearside’s Phase 2 post-TANZANITE extension in RVO, where 74% of patients did not receive additional treatment through at least nine months, “it looks highly plausible that CLS-003 could extend the durability of anti-VEGF administration meaningfully,” Ms. Samimy said.
“This would be a paradigm shift in treatment for RVO, taking away the frequency of injections and the significant cost of anti-VEFG treatment,” she added.
Clearside is proceeding with multiple parallel programs in macular edema, including non-infectious uveitis, RVO and DME.