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Operator
Operator
Good day and thank you for standing by. Welcome to the Sight Sciences' second-quarter 2023 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.
美好的一天,感謝您的支持。歡迎參加 Sight Sciences 2023 年第二季財報電話會議。 (操作員指示)請注意,今天的會議正在錄製中。
I would now like to hand the conference over to your speaker today, Trip Taylor, Investor Relations. Please go ahead, Trip.
現在,我想將會議交給今天的演講者,投資者關係部門 Trip Taylor。請繼續,特里普。
Philip Taylor - IR
Philip Taylor - IR
Thank you for participating in today's call. Presenting today are Sight Sciences' Co-Founder and Chief Executive Officer, Paul Badawi; Chief Financial Officer, Ali Bauerlein; and Head of Corporate Strategy, Tom Huang. Earlier today, Sight Sciences released financial results for the three months ended June 30, 2023. A copy of the press release is available on the company's website at investors.sightsciences.com.
感謝您參加今天的電話會議。今天發言的是 Sight Sciences 聯合創辦人兼執行長 Paul Badawi;財務長 Ali Bauerlein;兼企業策略主管 Tom Huang。今天早些時候,Sight Sciences 發布了截至 2023 年 6 月 30 日的三個月財務業績。新聞稿的副本可在該公司網站 Investors.sightsciences.com 上取得。
I'd like to remind everyone that comments made by management today and answers to questions will include forward-looking statements within the meaning of the federal securities laws. These forward-looking statements include statements related to Sight Sciences' anticipated financial performance and operating results, market opportunity, business strategy, and plans for developing and marketing new products. Forward-looking statements are based on estimates and assumptions as of today are neither promises nor guarantees and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements. A description of some of the risks and uncertainties that could cause actual results to differ materially from those indicated by the forward-looking statements on this call can be found in the Risk Factors section of the annual report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.
我想提醒大家,管理層今天發表的評論和對問題的回答將包括聯邦證券法含義內的前瞻性陳述。這些前瞻性陳述包括與 Sight Sciences 的預期財務表現和經營績效、市場機會、業務策略以及開發和行銷新產品的計劃相關的陳述。前瞻性陳述是基於截至目前的估計和假設,既不是承諾也不是保證,並且存在風險和不確定性,可能導致實際結果與這些陳述明示或暗示的結果有重大差異。有關可能導致實際結果與本次電話會議中前瞻性陳述所表明的結果存在重大差異的一些風險和不確定性的描述,請參見截至本年度 10-K 表格年度報告的風險因素部分。2022 年 12 月31 日,向美國證券交易委員會提交。除法律要求外,本公司不承擔公開更新或修改任何前瞻性聲明的義務。
I will now turn the call over to Paul.
我現在將把電話轉給保羅。
Paul Badawi - Founder and CEO
Paul Badawi - Founder and CEO
Thanks, Trip. Our strong second quarter performance displayed the continued successful execution of our growth initiatives across surgical glaucoma and dry eye. We generated record total revenue of $23.5 million, growing 36% compared to the second quarter of 2022. We saw great revenue growth in both of our businesses, propelled by strong commercial activity and expanding clinical evidence supporting the value proposition of our technologies.
謝謝,特里普。我們強勁的第二季業績顯示我們在手術青光眼和乾眼領域的成長計畫持續成功執行。我們創造了創紀錄的總收入2350 萬美元,與2022 年第二季度相比增長了36%。在強勁的商業活動和支持我們技術價值主張的不斷擴大的臨床證據的推動下,我們的兩項業務收入都實現了巨大的成長。
Most notably, we were thrilled to announce the success of SAHARA, our landmark device versus drug, randomized controlled clinical trial, comparing interventional eyelid procedures enabled by our TearCare technology to Restasis for the treatment of dry eye. At the six-month endpoint, interventional eyelid procedures enabled by TearCare technology were superior to Restasis in improving tear break up time or TBUT, the primary objective signs endpoint. TearCare was also non-inferior to Restasis with respect to improvement in Ocular Surface Disease Index or OSDI, the primary subjective symptoms endpoint.
最值得注意的是,我們很高興地宣布SAHARA 取得成功,這是我們具有里程碑意義的設備與藥物的隨機對照臨床試驗,該試驗將我們的TearCare 技術實現的介入眼瞼手術與Restasis 治療乾眼症的效果進行了比較。在六個月的終點,由 TearCare 技術實現的介入性眼瞼手術在改善淚液破裂時間或 TBUT(主要客觀體徵終點)方面優於 Restasis。在眼表疾病指數或 OSDI(主要主觀症狀終點)的改善方面,TearCare 也不遜於 Restasis。
As importantly, patients in the TearCare Group demonstrated clinically and statistically significant improvements of all 10 signs and symptoms endpoints measured at every observation interval. We are extremely excited about these clinical results and believe they will lay the foundation for us to help physicians rethink how they treat dry eye and transform the market by moving away from daily prescription eye drops and towards once or twice a year interventional dry eye procedures.
同樣重要的是,TearCare 組的患者在每個觀察間隔測量的所有 10 個體徵和症狀終點均表現出臨床和統計學上的顯著改善。我們對這些臨床結果感到非常興奮,並相信它們將為我們奠定基礎,幫助醫生重新思考如何治療乾眼症,並透過從每日處方眼藥水轉向每年一次或兩次乾眼介入手術來改變市場。
An abstract of the six-month Phase 1 results from SAHARA has been accepted by the American Academy of Optometry for presentation at its annual meeting in October. We look forward to discussing the SAHARA data with payers as a key part of our efforts to establish reimbursement and fair patient access for TearCare treatments.
SAHARA 為期 6 個月的第一階段結果摘要已被美國視光學會接受,並在 10 月的年會上展示。我們期待與付款人討論 SAHARA 數據,作為我們努力建立報銷和公平患者獲得 TearCare 治療的關鍵部分。
To begin our surgical glaucoma discussion, I would like to address the draft LCDs for MIGS recently proposed by five MACs that could impact sales of our OMNI and SION products. These MACs administer Part B Medicare benefits for Medicare fee-for-service patients on behalf of CMS. We believe these proposals have numerous serious flaws and would adversely affect Medicare patients and limit surgeons' ability to provide proven, effective treatments for their glaucoma patients if implemented as currently drafted. In particular, the proposed LCDs have not considered all the available clinical data, demonstrating the benefits of OMNI procedures, which have been published in at least 18 peer-reviewed publications. Our extensive clinical data, real-world outcomes, and broad FDA label reinforce the safe and effective use of our OMNI technology in adult patients with primary open-angle glaucoma or POAG.
在開始討論青光眼手術之前,我想談談五家 MAC 最近提出的 MIGS LCD 草案,該草案可能會影響我們 OMNI 和 SION 產品的銷售。這些 MAC 代表 CMS 為 Medicare 按服務收費患者管理 B 部分 Medicare 福利。我們認為這些提案存在許多嚴重缺陷,如果按目前起草的實施,將對醫療保險患者產生不利影響,並限制外科醫生為青光眼患者提供經過驗證的有效治療的能力。特別是,建議的 LCD 並未考慮所有可用的臨床數據,證明了 OMNI 程序的優點,該程序已在至少 18 個同行評審出版物中發表。我們廣泛的臨床數據、真實世界的結果和廣泛的 FDA 標籤強化了我們的 OMNI 技術在原發性開角型青光眼或 POAG 成年患者中的安全有效使用。
These five MACs have hosted public open comment meetings regarding the proposed LCDs. Medical societies, physicians, and patients have provided overwhelming support for continued access to OMNI technology, expressing the critical nature of the benefits enabled by and the importance of continued access to our OMNI technology to help preserve the vision of POAG patients. In our presentations at the MACs open meetings, we reiterated the important role canaloplasty and trabeculotomy play in the treatment of glaucoma and highlighted additional clinical data which was not considered in the draft LCDs.
這五個 MAC 已就擬議的 LCD 舉辦了公開評論會議。醫學會、醫生和患者為繼續使用 OMNI 技術提供了壓倒性的支持,表達了繼續使用 OMNI 技術所帶來的益處的關鍵性質以及繼續使用 OMNI 技術以幫助保留 POAG 患者視力的重要性。在 MAC 公開會議上的演講中,我們重申了淚管成形術和小梁切開術在青光眼治療中的重要作用,並強調了 LCD 草案中未考慮的其他臨床數據。
Specifically, we presented results from the two-year extension of our multicenter ROMEO study. This important study demonstrated the reduction in both intraocular pressure or IOP and glaucoma medication use in mild-to-moderate POAG patients treated with OMNI that we originally observed at 12 months, extended out to 24 months. This longer-term data provides further evidence of the durability and efficacy of our OMNI technology.
具體來說,我們展示了多中心 ROMEO 研究延長兩年的結果。這項重要的研究表明,接受 OMNI 治療的輕中度 POAG 患者的眼壓或 IOP 以及青光眼藥物使用量均有所降低,我們最初在 12 個月時觀察到的情況延長至 24 個月。這些長期數據進一步證明了我們 OMNI 技術的耐用性和有效性。
We also presented 12-month results from GEMINI, our prospective multicenter trial of OMNI, in combination with cataract surgery. In GEMINI, we observed significant reductions in both IOP and medication usage with OMNI compared to the historical cataract control. GEMINI had prespecified success criteria to exceed the IOP reduction due to cataract surgery alone as observed in the control arms of the pivotal MIGS implant studies. The prospective study successfully met its prespecified efficacy endpoint with statistically significantly greater IOP reduction at 12 months than the historical control arm.
我們也發表了 GEMINI 的 12 個月結果,GEMINI 是我們對 OMNI 與白內障手術相結合的前瞻性多中心試驗。在 GEMINI 中,我們觀察到與歷史白內障控制相比,OMNI 的眼壓和藥物使用量均顯著降低。 GEMINI 預先設定了成功標準,以超過僅因白內障手術導致的眼壓降低,如在關鍵 MIGS 植入物研究的對照組中觀察到的那樣。這項前瞻性研究成功達到了其預先設定的療效終點,12 個月時眼壓降低程度顯著高於歷史對照組。
Our presentation to the various MACs further highlighted and described the consistency of positive outcomes observed across the published articles. We appreciate the efforts made by all of the physicians, patients, societies, and other stakeholders who helped educate the MACs regarding the necessary and crucial role that our OMNI technology plays in the treatment of POAG. We would also like to thank all of the dedicated site employees particularly in our clinical, commercial, and market access groups who coordinated our exceptional response.
我們向各個 MAC 的演示進一步強調並描述了已發表文章中觀察到的正面結果的一致性。我們感謝所有醫生、患者、社會和其他利害關係人所做的努力,他們幫助教育 MAC,讓他們了解我們的 OMNI 技術在 POAG 治療中所發揮的必要和關鍵作用。我們也要感謝所有敬業的現場員工,特別是我們的臨床、商業和市場准入團隊中的員工,他們協調了我們的出色反應。
We do not believe there is a supportable basis for the implementation of these proposed LCDs as they are currently drafted. Coverage criteria are based on published clinical evidence, significant clinical benefits that are equivalent or superior to other Medicare covered procedures, consensus clinical guidelines, generally accepted standard of care, and FDA clearance specific to glaucoma therapy, all of which favor and support continued coverage of the procedures enabled by OMNI technology.
我們認為目前起草的這些擬議 LCD 的實施沒有可支持的基礎。承保標準基於已發表的臨床證據、與其他Medicare 承保程序相當或優於其他醫療保險的顯著臨床益處、共識臨床指南、普遍接受的護理標準以及針對青光眼治療的FDA 許可,所有這些都贊成並支持繼續承保OMNI 技術支援的程序。
We plan to continue to communicate with all stakeholders regarding the published clinical evidence and real-world results, supporting the safety and efficacy of our OMNI technology and the importance of continued and appropriate coverage to preserve access to these treatment options for POAG patients. We don't have visibility at this time as to when the MACs will either revise, withdraw, or finalize their proposed LCDs, but we believe we have provided clinical information sufficient to maintain coverage for procedures enabled by our OMNI technology.
我們計劃繼續與所有利益相關者就已發布的臨床證據和實際結果進行溝通,支持我們 OMNI 技術的安全性和有效性,以及持續和適當的覆蓋範圍以保持 POAG 患者獲得這些治療選擇的重要性。目前我們無法得知 MAC 何時會修改、撤回或最終確定其提議的 LCD,但我們相信我們已經提供了足夠的臨床資訊來維持我們 OMNI 技術支援的程序的覆蓋範圍。
In other news, we were pleased to report in June that Cigna, one of the largest commercial health insurance companies in the United States with almost 15 million covered lives, revised their glaucoma surgical procedures coverage policy to include procedures performed with our OMNI technology as medically necessary and covered as of June 15, 2023. This decision further validates OMNI's clinical importance. We are excited to bring the benefits of OMNI to the Cigna community.
在其他新聞中,我們很高興在6 月報道Cigna,美國最大的商業健康保險公司之一,為近1500 萬人提供保險,修訂了其青光眼手術保險政策,將使用我們的OMNI 技術進行的手術納入醫療範圍。必要並自 2023 年 6 月 15 日起承保。這項決定進一步驗證了 OMNI 的臨床重要性。我們很高興能夠將 OMNI 的優勢帶給 Cigna 社區。
Commercially, our surgical glaucoma business growth continued to outpace the MIGS market overall as more clinicians adopted our OMNI technology. As evidenced by our record quarterly revenue, commercial activity for the second quarter exceeded our expectations. Notably, net account retention was particularly strong despite the current market considerations associated with the proposed LCDs. It's clear that with continued market access, we have a sticky, stable, and expandable revenue opportunity via our growing surgeon base. Feedback from surgeons who use OMNI continues to be very positive. We attribute this customer stability and stickiness to the differentiated consistency and degree of efficacy of our OMNI technology, its exceptional usability, and our commercial excellence.
在商業上,隨著越來越多的臨床醫生採用我們的 OMNI 技術,我們的青光眼手術業務成長持續超過 MIGS 市場。正如我們創紀錄的季度收入所證明的那樣,第二季的商業活動超出了我們的預期。值得注意的是,儘管當前市場考慮到與擬議的 LCD 相關的問題,但淨帳戶保留率仍然特別強勁。顯然,隨著持續的市場准入,我們透過不斷增長的外科醫生基礎獲得了黏性、穩定和可擴展的收入機會。使用 OMNI 的外科醫生的回饋仍然非常積極。我們將這種客戶穩定性和黏性歸功於我們 OMNI 技術的差異化一致性和功效程度、卓越的可用性以及我們的商業卓越性。
I would like to congratulate the graduating class of 2023 ophthalmic surgical residents and fellows. Our outstanding strategic accounts team has worked hand-in-hand with over 160 of these new surgeons to develop their expertise using our technologies. We look forward to partnering with this latest generation of surgeons to improve the lives of patients with POAG in the years to come.
我謹祝賀 2023 年眼科外科住院醫師和研究員的畢業班。我們優秀的策略客戶團隊與 160 多名新外科醫生攜手合作,利用我們的技術發展他們的專業知識。我們期待與最新一代的外科醫生合作,在未來幾年改善 POAG 患者的生活。
OMNI continues to perform well within the combo cataract segment, and we are encouraged by the market expansion and accelerating penetration we're observing in standalone MIGS. Based on projected claims data from a third-party analytics provider, we observed expanded stand-alone activity as measured by the growth in standalone patient visits involving CPT codes associated with OMNI. While stand-alone procedure volumes remain modest compared to the combo cataract segment, we remain confident in our ability to drive increasing awareness and growth of our OMNI technology in this segment through a comprehensive market development program, which leverages standalone clinical evidence, targeted field resources, comprehensive patient and physician education, and marketing initiatives.
OMNI 在組合白內障細分市場中繼續表現良好,我們對獨立 MIGS 中觀察到的市場擴張和滲透率加速感到鼓舞。根據第三方分析提供者的預期索賠數據,我們觀察到獨立活動的擴大,這是透過涉及與 OMNI 相關的 CPT 代碼的獨立患者就診量的增長來衡量的。雖然與組合白內障細分市場相比,獨立手術量仍然不大,但我們仍然有信心透過全面的市場開發計劃,利用獨立的臨床證據和有針對性的現場資源,提高OMNI 技術在該細分市場的認知度和增長。 、全面的患者和醫生教育以及營銷舉措。
The other product in our surgical glaucoma portfolio, SION, also contributed to our growth in the second quarter. SION addresses the needs of surgeons seeking a simpler MIGS solution for certain patients. We are pleased with the positive industry reception for SION, although it is still a small overall contributor to total revenue.
我們的青光眼手術產品組合中的另一個產品 SION 也為我們第二季的成長做出了貢獻。 SION 滿足了外科醫生為某些患者尋求更簡單的 MIGS 解決方案的需求。我們對 SION 受到業界的積極歡迎感到高興,儘管它對總收入的整體貢獻仍然很小。
Turning to our dry eye business. We designed our TearCare technology to address the serious unmet needs of patients with evaporative dry eye and meibomian gland disease or MGD, which is associated with up to 86% of dry eye cases. Historically, treatment for dry eye has been dominated by artificial tears and prescription eye drops, both of which have clinical limitations and do not address the underlying causes of MGD.
轉向我們的乾眼業務。我們設計 TearCare 技術是為了解決蒸發乾眼症和瞼板腺疾病 (MGD) 患者嚴重未滿足的需求,這種疾病與高達 86% 的乾眼症病例有關。從歷史上看,乾眼症的治療主要是人工淚液和處方眼藥水,這兩種方法都有臨床局限性,並且無法解決 MGD 的根本原因。
We believe the Phase 1 results observed in SAHARA demonstrate that our TearCare technology should play a prominent role in the dry eye treatment paradigm. During our controlled commercial launch, we have experienced growing adoption of TearCare as a self-pay treatment option, illustrating the pent-up demand for a procedure that can offer safe and effective relief from MGD. We believe there is immense potential for our TearCare technology with fair and appropriate reimbursement.
我們相信,在 SAHARA 觀察到的第一階段結果表明,我們的 TearCare 技術應該在乾眼治療範例中發揮重要作用。在我們受控的商業推出過程中,我們看到越來越多的人採用 TearCare 作為自費治療選擇,這說明了對能夠安全有效緩解 MGD 的手術的被壓抑的需求。我們相信,透過公平和適當的報銷,我們的 TearCare 技術具有巨大的潛力。
We are thrilled by the success of SAHARA, the first of its kind head-to-head device-first drug RCT, comparing treatments using our TearCare technology to twice daily use of prescription eye drop treatment with Restasis. In this trial, 345 patients at 25 sites in 14 states were randomized 1 to 1 between TearCare and Restasis groups. SAHARA achieved its primary clinical science six-month endpoint, demonstrating the superiority of interventional eyelid procedures enabled by TearCare over Restasis eyedrops and improving tear break up time, a key measure of aqueous retention, tear stability, and the tear film's ability to protect the ocular surface.
我們對 SAHARA 的成功感到興奮,這是同類中首個頭對頭設備優先藥物隨機對照試驗,將使用我們的 TearCare 技術的治療與每天兩次使用 Restasis 處方滴眼液治療進行比較。在這項試驗中,14 個州 25 個地點的 345 名患者被隨機分為 TearCare 組和 Restasis 組,分為 1 比 1。 SAHARA 實現了其六個月的主要臨床科學終點,證明了TearCare 實現的介入性眼瞼手術相對於Restasis 滴眼液的優越性,並改善了淚液破裂時間,淚液破裂時間是水瀦留、淚液穩定性和淚膜保護眼部能力的關鍵指標表面。
Throughout the study, interventional eyelid procedures with TearCare demonstrated clinically and statistically significant improvements of all 10 endpoints at every measurement interval evaluated to date: one week, one month, three months, and six months. We designed the SAHARA RCT with exacting standards to minimize potential bias and to ensure that the results, if successful, would provide meaningful support for healthy payer coverage discussions.
在整個研究過程中,使用TearCare 進行的眼瞼介入手術顯示,在迄今為止評估的每個測量間隔(一周、一個月、三個月和六個月)中,所有10 個終點均取得了臨床和統計學上的顯著改善。我們按照嚴格的標準設計了撒哈拉隨機對照試驗,以盡量減少潛在的偏見,並確保結果如果成功,將為健康的付款人保險討論提供有意義的支持。
These measures included setting the superiority endpoint at six months rather than the one or three months period common in dry eye studies. We did this intentionally to help ensure Restasis has sufficient time to reach peak effect. Endpoint assessments were carried out by assessors masked to treatment assignment to further minimize potential bias.
這些措施包括將優越性終點設定為六個月,而不是乾眼研究中常見的一到三個月。我們故意這樣做是為了幫助確保 Restasis 有足夠的時間達到峰值效果。終點評估由不接受治療分配的評估人員進行,以進一步減少潛在的偏差。
In coordination with the study's principal investigators, we plan to submit Phase 1 results from SAHARA to leading peer-reviewed journals. We are also preparing associated health economics and outcomes research and a budget impact model for publication. If successfully published, we believe these articles will encourage doctors to revamp the treatment of dry eye disease and provide payers with persuasive evidence to support patient access and reimbursement.
我們計劃與該研究的主要研究人員協調,將 SAHARA 的第一階段結果提交給領先的同行評審期刊。我們也正在準備相關的衛生經濟學和成果研究以及預算影響模型以供出版。如果成功發表,我們相信這些文章將鼓勵醫生改進乾眼症的治療方法,並為付款人提供有說服力的證據來支持患者獲得治療和報銷。
To date, payers have not received the rigorous RCT data for dry eye procedures that we believe SAHARA provides. SAHARA highlights our commitment to rigorous clinical evidence, and we are very pleased with the results. I would like to recognize the exceptional efforts of our clinical team, our team of investigators, and all the patients involved with this important trial. The TearCare technology was designed to intervene at the root cause of MGD comprehensively in a user-friendly way and has now demonstrated the ability to consistently produce best-in-class clinical outcomes in two RCTs. We look forward to advancing our TearCare market access strategy, expanding usage of our OMNI technology, and improving the lives of patients suffering from chronic eye diseases.
迄今為止,付款人尚未收到我們認為 SAHARA 提供的有關乾眼手術的嚴格 RCT 數據。 SAHARA 強調了我們對嚴格臨床證據的承諾,我們對結果非常滿意。我要對我們的臨床團隊、研究人員團隊以及參與這項重要試驗的所有患者所付出的傑出努力表示認可。 TearCare 技術旨在以使用者友好的方式全面乾預 MGD 的根本原因,現已在兩項隨機對照試驗中證明能夠持續產生一流的臨床結果。我們期待推進 TearCare 市場准入策略,擴大 OMNI 技術的使用,並改善慢性眼疾患者的生活。
I will now turn the call over to Ali to discuss our financials.
我現在將把電話轉給阿里,討論我們的財務狀況。
Ali Bauerlein - CFO
Ali Bauerlein - CFO
Thanks, Paul. I'm excited by the progress we have made this quarter across both surgical glaucoma and dry eye. Total revenue for the second quarter was $23.5 million, representing 36% growth compared to the second quarter of 2022. Surgical glaucoma revenues for the second quarter were $21.4 million, up 35% versus the comparable period.
謝謝,保羅。我對本季我們在手術青光眼和乾眼方面取得的進展感到興奮。第二季總營收為 2,350 萬美元,較 2022 年第二季成長 36%。第二季青光眼手術營收為 2,140 萬美元,較去年同期成長 35%。
Over 1,100 customers ordered surgical glaucoma products in the second quarter, up 30% compared to the prior-year period. Our commercial team did a tremendous job introducing our technologies to new customers and maintaining strong relationships with existing customers in the second quarter particularly given the uncertainty associated with the proposed LCD.
第二季有超過 1,100 名客戶訂購了青光眼手術產品,比去年同期成長了 30%。我們的商業團隊在第二季向新客戶介紹我們的技術並與現有客戶保持牢固的關係方面做得非常出色,特別是考慮到與擬議的 LCD 相關的不確定性。
Our dry eye revenue for the second quarter was $2.1 million, up 56% compared to the second quarter of 2022. As we prepare to evolve TearCare beyond the controlled launch phase in the coming quarters, we would like to help investors better understand our dry eye business by introducing new operating metrics and a more targeted view of our core addressable market.
我們第二季的乾眼收入為210 萬美元,比2022 年第二季成長56%。當我們準備在未來幾季將TearCare 發展到受控發布階段之外時,我們希望幫助投資者更好地了解我們的乾眼症透過引入新的營運指標和對我們的核心目標市場更有針對性的觀點來開展業務。
We see vast potential to improve the lives of patients across the spectrum of mild, moderate, and advanced dry eye disease. Our market research indicates that of the approximately 17.8 million patients with dry eye disease, there are between 11.6 million and 15.5 million diagnosed MGD patients in the US. Approximately 55% of these patients or 6.4 million to 8.5 million patients would be categorized with moderate to severe MGD, and we believe these patients are the most likely candidates for treatments like TearCare.
我們看到了改善輕度、中度和晚期乾眼症患者生活的巨大潛力。我們的市場研究表明,在美國約 1,780 萬名乾眼症患者中,有 1,160 萬至 1,550 萬名被診斷為 MGD 患者。這些患者中約 55% 或 640 萬至 850 萬患者被歸類為中度至重度 MGD,我們相信這些患者最有可能接受 TearCare 等治療。
While patients with mild MGD can also benefit from treatments such as TearCare, these patients and their eye care providers may not feel the same urgency to seek out a TearCare procedure until the patient symptoms progress. Given the significant MGD patient population, we believe it is important to initially target the patients that eye doctors can most easily identify and are more likely to proactively seek treatment. Consistent with the patient enrollment criteria in our SAHARA pivotal RCT and the corresponding coverage we will initially pursue in the United States, this core opportunity generally consists of moderate and advanced MGD patients.
雖然輕度 MGD 患者也可以從 TearCare 等治療中受益,但在患者症狀出現進展之前,這些患者及其眼部保健提供者可能不會同樣迫切地尋求 TearCare 手術。鑑於 MGD 患者群體龐大,我們認為首先針對眼科醫師最容易識別且更有可能主動尋求治療的患者非常重要。與我們 SAHARA 關鍵隨機對照試驗中的患者入組標準以及我們最初在美國追求的相應覆蓋範圍一致,這一核心機會通常由中度和晚期 MGD 患者組成。
Assuming moderate patients receive one treatment per year and severe patients received two treatments per year, resulting in an average of 1.3 treatments per year and our current SmartLids average selling price, this would yield a core addressable moderate to advanced treatment market of approximately $2.5 billion.
假設中度患者每年接受一次治療,重度患者每年接受兩次治療,平均每年接受1.3 次治療,按照我們目前的SmartLids 平均售價,這將產生約25 億美元的核心可尋址中度至高級治療市場。
Currently, over-the-counter and prescription eye drops are the dominant treatment for dry eye with the cost of payers and patients estimated to exceed $2 billion annually. We believe the superior results from SAHARA, coupled with ongoing technology enhancements, could allow us to increase overall prices in the future. In addition, there are opportunities for us to pursue mild MGD patients over time and expand into new markets worldwide, which would further increase our opportunity.
目前,非處方藥和處方眼藥水是乾眼症的主要治療方法,每年支付者和患者的費用估計超過 20 億美元。我們相信 SAHARA 的卓越成果,加上持續的技術改進,可以讓我們在未來提高整體價格。此外,隨著時間的推移,我們還有機會尋找輕度 MGD 患者並擴展到全球新市場,這將進一步增加我們的機會。
We believe informative metrics to measure the performance of our dry eye segment, including dry eye active customers, which we define as the number of customers who have ordered eyelid treatment units or SmartLids during the preceding three-month period and the number of eyelid treatment units sold. This data provides a broad picture of account activity and product utilization that we believe will be important as we expand.
我們相信衡量乾眼細分市場表現的資訊指標,包括乾眼活躍客戶,我們將其定義為在過去三個月內訂購眼瞼治療裝置或 SmartLids 的客戶數量以及眼瞼治療裝置的數量賣。這些數據提供了帳戶活動和產品利用率的整體情況,我們認為隨著我們的擴張,這些數據將非常重要。
For the second quarter of 2023, we had 370 active dry eye customers, a 75% increase versus the second quarter of 2022. Additionally, we sold almost 6,000 eyelid treatment units in the quarter, a 69% increase versus the prior-year period. Gross margin for the second quarter was 85.6% compared to 84.1% in the prior-year period. Gross margin improvement was attributed to improvement in both surgical glaucoma gross margin and dry eye gross margin.
2023 年第二季度,我們有 370 名活躍乾眼客戶,比 2022 年第二季度增加了 75%。此外,我們在本季度銷售了近 6,000 台眼瞼治療儀,比去年同期增加了 69%。第二季毛利率為 85.6%,去年同期為 84.1%。毛利率的改善歸因於手術青光眼毛利率和乾眼毛利率的改善。
Surgical glaucoma gross margin improved primarily due to manufacturing efficiencies generated as a result of higher production volumes, partially offset by lower average selling price due to product mix. Dry eye gross margin improved primarily due to an increased mix of higher gross margin SmartLids versus SmartHubs and higher average selling price of SmartHubs.
手術青光眼毛利率的改善主要是由於產量增加而提高了製造效率,但部分被產品組合導致的平均售價降低所抵消。乾眼毛利率的改善主要是由於 SmartLids 相對於 SmartHub 的毛利率更高以及 SmartHub 的平均售價更高。
R&D expenses were $5.2 million compared to $5.9 million in the second quarter of 2022. And SG&A expenses were $30.1 million compared to $31.4 million in the prior-year period. Total operating expenses for the second quarter were $35.3 million, a decrease of 6% compared to $37.4 million in the second quarter of 2022 and in line with our expectations.
研發費用為 520 萬美元,而 2022 年第二季為 590 萬美元。SG&A 費用為 3,010 萬美元,而去年同期為 3,140 萬美元。第二季總營運費用為 3,530 萬美元,比 2022 年第二季的 3,740 萬美元下降 6%,符合我們的預期。
We continue to monitor operating expenses closely and are pleased with the results. Adjusted operating expenses for the quarter were $31.5 million. As expected, adjusted operating expenses were slightly higher than our estimated 2023 quarterly average target of $30.5 million given the timing of certain expenditures within the year. Our loss from operations for the second quarter was $15.2 million compared to a loss of $22.9 million in the second quarter of 2022.
我們繼續密切監控營運費用並對結果感到滿意。該季度調整後的營運費用為 3,150 萬美元。正如預期的那樣,考慮到年內某些支出的時間安排,調整後的營運支出略高於我們估計的 2023 年季度平均目標 3050 萬美元。我們第二季的營運虧損為 1,520 萬美元,而 2022 年第二季的營運虧損為 2,290 萬美元。
We had a net loss of $14.8 million or $0.30 per share in the quarter compared to a net loss of $23.8 million or $0.50 per share for the second quarter of 2022. We ended the quarter with $154.5 million of cash and cash equivalents and $35 million of long-term debt, excluding debt discounts and amortized debt issuance costs. In July, we terminated our unused $5 million debt revolver facility since we had no intention to draw it.
我們本季的淨虧損為1,480 萬美元,即每股0.30 美元,而2022 年第二季的淨虧損為2,380 萬美元,即每股0.50 美元。本季末,我們的現金和現金等價物為1.545 億美元,現金及現金等價物為1.545 億美元,現金及現金等價物為3,500 萬美元。長期債務,不包括債務折現及攤銷債務發行成本。 7 月份,我們終止了未使用的 500 萬美元債務循環融資,因為我們無意提取它。
Demonstrating our progress to cash flow breakeven, cash usage decreased to $12.8 million in the second quarter of 2023 compared to $17.7 million in the first quarter of 2023 and $18.5 million in the second quarter of 2022.
2023 年第二季的現金使用量下降至1,280 萬美元,而2023 年第一季為1,770 萬美元,2022 年第二季為1,850 萬美元,證明了我們在實現現金流損益平衡方面取得的進展。
Overall, we expect operating loss and cash usage will continue to decrease over time as operating leverage increases driven by our high gross margins and targeted operating spend. Based on our solid year-to-date results, we are reaffirming our annual revenue guidance of $89 million to $94 million. We believe it is prudent to maintain our guidance range despite the solid year-to-date results, primarily due to the uncertainty associated with the proposed coverage changes in our surgical glaucoma segment. In addition, we expect the seasonality of our revenue to begin to align with typical industry patterns that see lower procedure volumes in the summer months.
總體而言,我們預計隨著時間的推移,隨著我們的高毛利率和目標營運支出推動營運槓桿增加,營運虧損和現金使用量將繼續減少。基於我們今年迄今的穩健業績,我們重申我們的年收入指引為 8,900 萬美元至 9,400 萬美元。我們認為,儘管今年迄今取得了穩健的業績,但維持我們的指導範圍是謹慎的做法,這主要是由於與我們的手術青光眼細分市場擬議的承保範圍變化相關的不確定性。此外,我們預期收入的季節性將開始與夏季程序量較低的典型行業模式保持一致。
We continue to expect that average quarterly adjusted operating expenses of approximately $30.5 million per quarter will allow us to achieve our plans for the year. We continue to target approximately 30% revenue growth in the medium term and positive free cash flow by year-end 2025 while maintaining a substantial cash cushion. Our medium-term financial outlook assumes that the seven MACs continue to cover OMNI procedures largely to the extent they are currently covered.
我們仍然預計,平均每季調整後的營運費用約為 3,050 萬美元,將使我們能夠實現今年的計劃。我們的目標繼續是中期收入成長約 30%,並在 2025 年底實現正自由現金流,同時保持大量現金緩衝。我們的中期財務前景假設七個 MAC 繼續在很大程度上覆蓋目前覆蓋的範圍內的 OMNI 程式。
With that, operator, you may open the line for questions. Tom Huang, our Head of Corporate Strategy, will also join us for Q&A.
這樣,接線員,您就可以打開提問線路了。我們的企業策略主管 Tom Huang 也將加入我們的問答環節。
Operator
Operator
(Operator Instructions) Craig Bijou, BofA.
(操作員說明)Craig Bijou,美國銀行。
Craig Bijou - Analyst
Craig Bijou - Analyst
Maybe just wanted to start. Obviously, you have this overhang with the MACs and the LCDs. And I appreciate the fact that you don't know what timing -- what the timing is to get an update. But maybe if we can -- if you could provide a little bit of color on what would happen if the LCDs were put into place, what are some of the options that you have if that were to happen? Maybe just kind of how to think about the timing of some of those.
也許只是想開始。顯然,MAC 和 LCD 存在這種懸而未決的情況。我很欣賞這樣一個事實,即您不知道什麼時間獲取更新。但也許如果我們可以——如果你能提供一些關於如果液晶顯示器安裝到位會發生什麼的信息,如果發生這種情況你有哪些選擇?也許只是如何思考其中一些的時機。
Ali Bauerlein - CFO
Ali Bauerlein - CFO
Sure. I'd be happy to take that question. First of all, what I would say is I'd remind everyone that we feel like we've done a very good job outlining our case to each of the MACs on why coverage should be maintained for our products. And I think that that's really important for investors to understand that we believe that the proposed LCDs will not be put in place as they currently stand, it will be revised in some capacity.
當然。我很樂意回答這個問題。首先,我想說的是,我想提醒大家,我們覺得我們已經做得非常好,向每個 MAC 概述了我們的案例,說明為什麼應該為我們的產品維持覆蓋範圍。我認為,讓投資者了解這一點非常重要,因為我們相信建議的 LCD 不會按目前的情況實施,而是會進行某種程度的修改。
We don't have, as we said in the prepared remarks, visibility on exactly when the MACs will decide to make a decision. They could individually make decisions of what they want to do for their coverage areas or they together could get together at a tax meeting again and have another discussion about options there.
正如我們在準備好的演講中所說,我們不知道 MAC 何時會做出決定。他們可以單獨決定他們想要在自己的覆蓋範圍內做什麼,或者他們可以再次聚在一起參加稅務會議,並就那裡的選擇進行另一次討論。
Of course, as we've said in our previous coverage of these issues, this is a significant portion of our surgical glaucoma revenue from 2022 are in the states covered by these MACs, so over 60%. So that is a significant portion of our revenue at risk, but we believe that it is a low chance that these LCDs will move forward in their current form. Our options, if they do, would be, of course, to go through an appeals process associated with those LCDs. Of course, we could also pursue an NCD or other coding options. So those would really be our main options if these do progress in the unlikely scenario that these move forward.
當然,正如我們在先前對這些問題的報告中所說,從 2022 年起,我們的青光眼手術收入的很大一部分來自這些 MAC 覆蓋的州,因此超過 60%。因此,這是我們收入的很大一部分面臨風險,但我們相信這些液晶顯示器以目前的形式向前發展的可能性很小。如果確實如此,我們的選擇當然是透過與這些 LCD 相關的上訴程序。當然,我們也可以追求 NCD 或其他編碼選項。因此,如果這些在不太可能發生的情況下確實取得進展,那麼這些確實將是我們的主要選擇。
Craig Bijou - Analyst
Craig Bijou - Analyst
Great, thank you, Ali. And I appreciate all of the color on the market opportunity for TearCare and would love to -- now that you have the strong data from SAHARA and the opportunity is now out there in front of you. Would love to get your updated thoughts or, I know it's early, but feedback on SAHARA from the docs. What you think SAHARA could do for insurance coverage going forward?
太好了,謝謝你,阿里。我很欣賞 TearCare 市場上所有的色彩機會,並且很樂意——既然您已經擁有來自撒哈拉的強大數據,而且機會就在您面前。希望得到您最新的想法,或者,我知道現在還為時過早,但是來自文件的關於 SAHARA 的反饋。您認為 SAHARA 可以為未來的保險覆蓋做些什麼?
And then I think you guys have talked about a similar growth between surgical glaucoma and dry eye going forward as part of your medium-range plan. So is that still the case? Or how should we think about the opportunity to grow the dry eye franchise in '24 and beyond?
然後我想你們已經談到了手術青光眼和乾眼症之間的類似增長,作為你們中期計劃的一部分。那麼現在還是這樣嗎?或者我們應該如何看待 24 年及以後發展乾眼特許經營權的機會?
Paul Badawi - Founder and CEO
Paul Badawi - Founder and CEO
Yeah. Hi, Craig, I'll take the first part of that question, and then maybe Ali can add on. I think the feedback from SAHARA from our investigators has been very, very strong. There's a lot of excitement. There's a lot of excitement internally here at Sight Sciences. I do want to remind everybody, SAHARA is our second RCT. Our first RCT, which was also very successful called OLYMPIA, we randomized TearCare against the first-mover leading MGD procedure and last year published superiority of symptoms in that trial.
是的。嗨,克雷格,我將回答這個問題的第一部分,然後也許阿里可以補充。我認為我們的調查人員對 SAHARA 的回饋非常非常強烈。有很多興奮。視覺科學公司內部充滿了興奮。我確實想提醒大家,SAHARA 是我們的第二個隨機對照試驗。我們的第一個隨機對照試驗(稱為 OLYMPIA)也非常成功,我們將 TearCare 與先行者領先的 MGD 手術進行了隨機對照,並在去年發表了該試驗中症狀的優越性。
This trial, SAHARA was another very ambitious study designed to transform treatment towards interventional procedures and away from drops, artificial tears and prescription eye drops, very rigorously designed. We spoke to a number of payer medical directors in advance of embarking on this journey.
SAHARA 試驗是另一項非常雄心勃勃的研究,旨在將治療轉向介入手術,遠離滴眼液、人工淚液和處方眼藥水,設計非常嚴格。在踏上這趟旅程之前,我們與一些付款人醫療主管進行了交談。
We wanted to make sure that the data that we would be able to provide payers if the study was successful would be meaningful to them making hopefully positive coverage decisions. We demonstrated, as we had mentioned in the prepared remarks, very consistent improvements in all signs and all symptoms. The study was a success. We demonstrated superiority to Restasis in our primary signs endpoint of tear break up time.
我們希望確保,如果研究成功,我們能夠向付款人提供的數據將對他們做出積極的核保決策有意義。正如我們在準備好的演講中提到的那樣,我們證明了所有體徵和症狀的持續改善。研究取得了成功。我們在淚膜破裂時間的主要徵兆終點方面表現出了優於 Restasis 的優勢。
In terms of the plan, we will be publishing or submitting for publication within the next few months. Hopefully, by the September timeframe, we'll submit to a top journal, if not the very top journal in eye care. We'd hope to get the publication by the end of the year, if all goes to plan. And we're in parallel assembling a very strong payer relations team.
就計劃而言,我們將在未來幾個月內出版或提交出版。希望在九月的時間範圍內,我們能夠提交給頂級期刊,即使不是眼保健領域的頂級期刊。如果一切按計劃進行,我們希望在今年年底前出版。我們同時正在組建一個非常強大的付款人關係團隊。
They're mapping out the strategy for 2024 in terms of which payers we're going to target first. So 2024 hopefully, with publication in hand, not just the publication in terms of the clinical data but also health economics research and the budget impact model with those publications and the strong payer relations team, we'll be working hard in 2024 with payers to hopefully start securing some coverage wins, which I would think in the 2025 timeframe, Ali, you can cover that what we would expect to see maybe with success.
他們正在製定 2024 年策略,確定我們首先要瞄準哪些付款人。因此,希望到2024 年,有了出版物,不僅是臨床數據方面的出版物,還包括健康經濟學研究和預算影響模型以及這些出版物和強大的付款人關係團隊,我們將在2024 年與付款人一起努力希望開始獲得一些報道勝利,我認為在 2025 年的時間範圍內,阿里,你可以報道我們期望看到的成功。
Ali Bauerlein - CFO
Ali Bauerlein - CFO
Yeah, sure. So happy to talk a little bit about where we see the trends going here. Obviously, we aren't prepared today to give any specific guidance for 2024 or 2025 associated with where we see the dry eye portion of the business going. We would be fairly cautious in expanding our commercial resources until we start seeing some market access wins.
好,當然。很高興能談談我們對這裡趨勢的看法。顯然,我們今天不准備就 2024 年或 2025 年的乾眼業務發展方向提供任何具體指導。在我們開始看到一些市場准入的勝利之前,我們在擴大商業資源方面將相當謹慎。
So for us, the priority in terms of our resources right now is to really go about securing appropriate and fair market access for TearCare. And as we get wins on that front, we would expect those to be accelerant to our revenue growth. Already, you see on our dry eye side of the business, because it's growing from a small base, it is growing quicker than our corporate average revenue growth rate. And we would expect, just given still the small base in the business, that that could continue.
因此,對我們來說,目前資源方面的首要任務是真正確保 TearCare 適當且公平的市場准入。當我們在這方面取得勝利時,我們預計這些將加速我們的收入成長。您已經看到我們的乾眼業務方面,因為它的成長基礎很小,所以它的成長速度超過了我們公司的平均收入成長率。我們預計,鑑於該業務的基礎仍然很小,這種情況可能會持續下去。
Now I think it will just depend on the timing of these market access agreements and how quickly we can ramp those up. But we see this as a very large market opportunity for us. We think we have great clinical results that we can share with the payers on why this is appropriate for coverage, but we need to go execute on that before we'll start talking about specific guidance and where we can take this opportunity.
現在我認為這將取決於這些市場准入協議的時間表以及我們能夠以多快的速度推進這些協議。但我們認為這對我們來說是一個非常大的市場機會。我們認為我們有很好的臨床結果,我們可以與付款人分享為什麼這適合承保,但在我們開始討論具體指導以及我們可以在哪裡利用這個機會之前,我們需要先執行這一結果。
Craig Bijou - Analyst
Craig Bijou - Analyst
Great, very helpful.
太棒了,非常有幫助。
Operator
Operator
(Operator Instructions) Tom Stephan, Stifel.
(操作員說明)Tom Stephan,Stifel。
Tom Stephan - Analyst
Tom Stephan - Analyst
Great. I'll start with TearCare and SAHARA more specifically. In regards to the payer discussions and ultimately trying to secure reimbursement, could you maybe put a little bit of a finer point around roughly, I guess, where you believe base case reimbursement for a single procedure might be for it to be viable? I guess, your ASP on the SmartLids is a good starting point, but maybe if you can just help us with how to think about when the reimbursement decisions come in, what's a good outcome? What's a great outcome, what you're targeting, et cetera. That'd be helpful.
偉大的。我將從 TearCare 和 SAHARA 開始更具體。關於付款人的討論以及最終試圖獲得報銷的問題,我想,您是否可以粗略地闡述一下,您認為單一程序的基本案例報銷可能是可行的?我想,您在 SmartLids 上的 ASP 是一個很好的起點,但也許如果您能幫助我們考慮如何考慮何時做出報銷決定,那麼好的結果是什麼?什麼是好的結果,你的目標是什麼,等等。那會有幫助的。
Ali Bauerlein - CFO
Ali Bauerlein - CFO
Yeah, Tom, what I'd say is, at this point, it's really too early. We are just now starting to think about engaging payers on that front, and we need to have those conversations and do the appropriate health economics and outcomes assessment to be able to set fair and reasonable reimbursement. I would say that even with our current business, we believe that this is a viable business on the self-pay market that we've already been accessing in the controlled launch. And we think that establishing fair reimbursement will only accelerate that patient access. But we aren't going to give specific ASP targets today because it's just too early for us to comment on that and provide anything realistic.
是的,湯姆,我想說的是,現在還太早。我們現在才開始考慮讓付款人參與這方面的工作,我們需要進行這些對話並進行適當的健康經濟學和結果評估,以便能夠設定公平合理的報銷。我想說的是,即使是我們目前的業務,我們也相信這在自付費市場上是一項可行的業務,我們已經在受控發布中進入了該市場。我們認為,建立公平的報銷只會加速患者獲得治療的機會。但我們今天不會給出具體的 ASP 目標,因為現在對此發表評論並提供任何實際的資訊還為時過早。
Paul Badawi - Founder and CEO
Paul Badawi - Founder and CEO
And I'll just add one comment to that, Tom. The design of SAHARA was deliberate. We randomized against the market-leading dry eye prescription Rx, which has sold billions of dollars over the years. And in discussions with payers, they naturally want to understand what they're paying for today, how it's working for the patients? Is it addressing their patient signs and symptoms? Is it addressing the underlying cause of disease? We know that TearCare does all of these things exceptionally well, and that prescription Rx can sometimes be prescribed to patients who really are in need of an interventional procedure addressing the underlying diseased meibomian gland.
湯姆,我只想對此添加一條評論。 SAHARA 的設計是經過深思熟慮的。我們隨機對照市場領先的乾眼處方藥 Rx,該藥多年來的銷售額已達數十億美元。在與付款人討論時,他們自然想了解他們今天支付的費用是什麼,它對患者有什麼作用?它是否能解決患者的徵兆和症狀?它是否解決了疾病的根本原因?我們知道 TearCare 在所有這些方面都做得非常好,有時可以為確實需要針對潛在患病瞼板腺進行介入手術的患者開處方 Rx。
So there's a lot of economics at stake right now. The design of SAHARA to randomize against costly prescription Rx was deliberate, and those prescriptions can cost thousands of dollars per year to the system and to patients -- so just you can rest assured on one thing that there's plenty of value here in terms of what the results look like for TearCare, the clinical value, the health economics value. So we're confident that, should we be successful in our payer coverage discussions, that there are -- there's a very attractive business model for all stakeholders, good value for all stakeholders.
所以現在有很多經濟問題。 SAHARA 設計隨機對照昂貴的處方 Rx 是經過深思熟慮的,這些處方每年會給系統和患者帶來數千美元的費用 - 所以你可以放心一件事,這裡有很多價值TearCare 的結果包括臨床價值、健康經濟學價值。因此,我們相信,如果我們在付款人覆蓋範圍討論中取得成功,就會有一個對所有利益相關者都非常有吸引力的商業模式,對所有利益相關者都有良好的價值。
Tom Stephan - Analyst
Tom Stephan - Analyst
Got it. That's helpful. And if I can set it to the glaucoma side of the business, maybe a two-parter. First, quickly, just on the IRIS Registry data, when can we expect to see the next tranche or set? I believe there were multiple analyses that were being explored? That's part one.
知道了。這很有幫助。如果我能把它放在青光眼方面,也許是兩方合作。首先,快速了解 IRIS 註冊數據,我們什麼時候可以看到下一批或一組?我相信正在探索多種分析?這是第一部分。
And then part two to this is just on competition in the US. Paul or Ali or Tom, just your latest thoughts and observations. More specifically, are you seeing Infinite a little bit more in the field? And then maybe how would you compare this year's competitive landscape in 2023 to last year where I think there were some challenges with new drugs.
第二部分只是關於美國的競爭。保羅、阿里或湯姆,只是您最新的想法和觀察。更具體地說,您是否在現場看到了更多的《Infinite》?然後,您如何將 2023 年的競爭格局與去年進行比較,我認為新藥面臨一些挑戰。
Tom Huang - Head of Corporate Strategy & Development
Tom Huang - Head of Corporate Strategy & Development
Yeah, Tom, I'll take a couple of those. First, starting off with IRIS. We're very excited about this data -- while we partnered with Verana who's got a license to this Iris real-world evidence database that's a American Academy of Ophthalmology's real-world outcomes database, thousands of cases of MIGS real world. We did -- our investigators have presented this year at various conferences, one-year outcomes, which are very exciting that show OMNI is very consistently effective in primary open-angle glaucoma.
是的,湯姆,我要幾個。首先,從 IRIS 開始。我們對這些數據感到非常興奮——我們與 Verana 合作,後者獲得了 Iris 真實世界證據數據庫的許可,該數據庫是美國眼科學會的真實世界結果數據庫,包含數千個 MIGS 真實世界病例。我們做到了——我們的研究人員今年在各種會議上展示了一年的結果,這些結果非常令人興奮,表明 OMNI 對原發性開角型青光眼始終有效。
And we're really looking forward to the two-year outcomes and getting those published. Very, very good results in terms of both IOP reduction as well as medication reduction. OMNI is -- the data showed OMNI was numerically greater than all of them and reached statistical significance across several of those arms.
我們非常期待兩年的成果並予以發布。在降低眼壓和減少藥物治療方面都取得了非常非常好的效果。 OMNI 是——數據顯示 OMNI 在數字上比所有這些都大,並且在其中幾個分支中達到了統計顯著性。
So it will be very important data, I think, for the field of MIGS to see. It will be submitted hopefully very soon within -- hopefully within a month or so, will be submitted to a very top journal, and we would hope to see publication by the end of the year. Yeah, that study, just to be more specific, it included OMNI cases, hundreds of OMNI cases, many, many Hydrus cases, many iStent cases, and cataract alone cases. And all of the MIGS interventions, OMNI, Hydrus, and iStent were performed in combination with cataract surgery. So that's IRIS. Hopefully, if all goes to plan, we could see a publication in a top-tier journal by the end of the year or early 2024.
因此,我認為,對於 MIGS 領域來說,這將是非常重要的數據。希望它很快就會提交——希望在一個月左右的時間內,將提交給一家非常頂級的期刊,我們希望在今年年底之前看到出版。是的,這項研究,更具體地說,它包括 OMNI 病例、數百個 OMNI 病例、很多很多 Hydrus 病例、很多 iStent 病例和單純白內障病例。所有 MIGS 介入措施、OMNI、Hydrus 和 iStent 均與白內障手術結合進行。這就是艾瑞絲。希望如果一切按計劃進行,我們可以在今年年底或 2024 年初在頂級期刊上看到一篇文章。
And that's two-year outcomes on both IOP reduction and medication reduction and it's very favorable to OMNI. In terms of competition, what are we seeing out there? We are seeing some use of stand-alone stents, Frankly, we welcome it, standalone, standalone market opportunities, as we've said many times, it's a huge market opportunity. There are many, many patients who need earlier effective surgical interventions. This market needs to be transformed away from meds, meds, meds, and lasers -- and then invasive surgery just like the combo cataract.
這是眼壓降低和藥物減少的兩年結果,這對 OMNI 非常有利。就競爭而言,我們看到了什麼?我們看到一些獨立支架的使用,坦白說,我們歡迎它,獨立的、獨立的市場機會,正如我們多次所說的,這是一個巨大的市場機會。有很多很多患者需要早期有效的手術介入。這個市場需要從藥物、藥物、藥物和雷射轉變,然後是侵入性手術,就像組合白內障一樣。
MIGS market has developed over the past decade. The standalone early intervention market needs to develop. It's a heavy lift. We've been doing a lot of that heavy lift on our own. For the past several years, we welcome others who can help in that lift as far as our position. We've been taking share and growing our business in the established MIGS market based on efficacy. We have very high confidence. That's why our surgeons and our customers are using OMNI in the stand-alone market based on that differentiated efficacy profile.
MIGS 市場在過去十年中不斷發展。獨立的早期介入市場需要發展。這是一個沉重的負擔。我們已經獨自完成了很多繁重的工作。在過去的幾年裡,我們歡迎其他能夠幫助我們達到我們職位的人。我們一直在基於功效的基礎上在成熟的 MIGS 市場中佔據份額並發展我們的業務。我們有很高的信心。這就是為什麼我們的外科醫生和客戶在獨立市場中基於差異化的功效特徵使用 OMNI。
So because we feel so confident that our surgeons love the clinical outcomes and rely on the clinical outcomes that they see with OMNI, and it's a touch a sticky business. It's in our interest to have competition come into the market and help develop the market and teach everybody, it's a very significant teaching exercise and education exercise, to move from standards of care of meds and lasers while patients are progressing to earlier surgical interventions.
因為我們非常有信心,我們的外科醫生喜歡臨床結果,並依賴他們透過 OMNI 看到的臨床結果,這是一項棘手的業務。讓競爭進入市場並幫助開發市場並教導每個人符合我們的利益,這是一項非常重要的教學活動和教育活動,從患者進展到早期手術幹預的藥物和雷射護理標準轉變。
And then lastly, in terms of the competition, 2022 versus 2023, I think 2022 was frankly noisier. There were a number of different products that were released that were new in terms of what they did, and it's harder to assess that market as those newer things were being introduced. I think this year, 2023, while there's introduction of standalone stenting as an example, that's something that's a little more familiar. It has been around for a long time, and it's something we understand and welcome.
最後,就競爭而言,2022 年與 2023 年相比,我認為 2022 年坦白說更加吵雜。發布了許多不同的產品,這些產品在功能上都是新的,隨著這些新產品的推出,評估該市場變得更加困難。我認為今年,即 2023 年,雖然會引入獨立支架置入術作為例子,但這是更熟悉的事情。它已經存在很長時間了,我們理解並歡迎它。
Tom Stephan - Analyst
Tom Stephan - Analyst
Got it. And maybe I can ask one follow-up to that. I wanted to ask about doctor trainings and facilities ordering on the MIGS side. I don't think we've received those figures for maybe a couple of quarters now. So Paul, if you can just talk to what a doctor trainings on OMNI, and I guess sign as well looked like over the past couple of quarters, maybe has competition or have the LCD noise slowed that a bit?
知道了。也許我可以問一個後續問題。我想詢問 MIGS 方面的醫生培訓和設施訂購情況。我認為我們可能已經有幾季沒有收到這些數據了。所以保羅,如果你能談談醫生在 OMNI 上接受的培訓,我想標誌在過去幾個季度看起來也像這樣,也許有競爭,或者 LCD 噪音是否減慢了一點?
Ali Bauerlein - CFO
Ali Bauerlein - CFO
Yeah. I'll take that one. We haven't disclosed the specific numbers on surgeon training. Q2 was also strong, saw great growth on a year-over-year basis, and we're pleased with that, and that's obviously a portion of what's driving our growth in overall surgical glaucoma up 35% year over year.
是的。我會接受那個。我們還沒有透露外科醫生培訓的具體數字。第二季也表現強勁,年比大幅成長,我們對此感到滿意,這顯然是推動我們整體手術青光眼年增 35% 的部分原因。
But we think the more important metric is active ordering accounts, and that is a number we do disclose that was up over 1,100 versus 875 in the second quarter last year, so up 30% year over year. In terms of impact associated with the proposed LCDs, we did have some sales rep just time impact in June associated with the proposed LCDs. Our staff spent time covering those changes, and that did have a small impact on surgeons trained and ordering accounts in the period, but not a material one. Obviously, we still exceeded expectations for the quarter, and we're happy with the overall growth rate in surgical glaucoma.
但我們認為更重要的指標是活躍訂購帳戶,我們確實披露了這個數字,與去年第二季度的 875 個相比,增加了 1,100 個以上,同比增長 30%。就與擬議的 LCD 相關的影響而言,我們確實在 6 月受到了一些與擬議的 LCD 相關的銷售代表的影響。我們的工作人員花時間報告這些變化,這確實對這段時期接受培訓的外科醫生和訂購帳戶產生了微小影響,但不是實質影響。顯然,我們仍然超越了本季的預期,並且我們對手術青光眼的整體成長率感到滿意。
Tom Stephan - Analyst
Tom Stephan - Analyst
Perfect, thanks everyone.
完美,謝謝大家。
Tom Huang - Head of Corporate Strategy & Development
Tom Huang - Head of Corporate Strategy & Development
Thanks.
謝謝。
Operator
Operator
Thank you. I am showing no further questions at this time. So I would like to turn the conference back over to Paul for closing remarks.
謝謝。我目前沒有提出任何進一步的問題。因此,我想將會議轉回由保羅發表閉幕詞。
Paul Badawi - Founder and CEO
Paul Badawi - Founder and CEO
Thank you all for your time and attention and interest in Sight Sciences. We appreciate it. Thank you and have a great day.
感謝大家的時間、關注以及對視覺科學的興趣。我們很感激。謝謝您,祝您有美好的一天。
Operator
Operator
This concludes today's conference call. Thank you for participating. You may now disconnect.
今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。